Corporate Announcements

Founded in 1925, ATCC is the world's leading Biological Resource Center. Its mission is to acquire, authenticate, preserve, produce, develop and share biological materials for the advancement of scientific knowledge. ATCC provides these core services to government, industry, education, health care and research laboratories around the world.

Below are some of the ways that ATCC strives to fulfill this mission. You may contact us with comments or inquiries regarding these announcements.

2010 Releases

ATCC to Hosts Emergency Training Drills

ATCC Awarded MID-BRR Contract with NIAID

ATCC Announces Rebranding

Launch of ATCC Certified Reference Materials 

ATCC Hosts Science Event

ATCC Partners with Biological Industries Ltd. — Exclusive Distributor for Israel

2009 Releases

ATCC SDO Releases First Standardized Consensus Protocol

ATCC Develops Novel Avian Flu Monoclonal Antibodies

 

2008 Releases

MicroBioLogics, Inc. Joins ATCC Proficiency Standard® Program

ATCC Achieves Accreditation as a Reference Material Producer

ATCC Gains ISO 9001:2000 Quality Management Systems Certification

Innovative Biosensors Inc. and ATCC Partner to Develop High-Speed Test for Avian Flu 

2007 Releases 

ATCC Vero Cells Used to Manufacture Second Rotavirus Vaccine for Clinical Trials
ATCC Standards Development Organization Receives ANSI Accreditation

R&D Systems Joins ATCC Proficiency Standard Program
CEDARLANE® Becomes Exclusive Distributor for Canada
Novel Biological Markers for Type 2 Diabetes Identified
Non-Animal Origin Microbial Products
Proficiency Standard Program Enlists CSCQ
College of American Pathologists Joins Proficiency Testing Program
Proficiency Standard Program Enlists API
ATCC Vero Cells Selected for Rotavirus Vaccine
New Quality Control Testing Tool
ACP Joins ATCC Proficiency Standard Program

2006 Releases

Collaboration Between ATCC and CLSI
ATCC Proficiency Testing Standard Program Launched
2007 ATCC Cell Biology Catalog Published
Remel Inc. Newest Addition to ATCC's LD Program
License Derivative Program Expands with Addition of Mecconti
Roche Diagnostics and ATCC Sign Partnership Agreement
Miclev Settles With ATCC On Trademark Lawsuit
Web-Based Standards Search Tool
Standards for Biodefense-related Materials
Gibson Labs Joins ATCC's Licensed-Derivative Program
Genmab Signs License Agreement with ATCC

2005 Releases
NCI Contract Awarded
Licensed Derivative Program Expands
Transfection Partnership
Escrow Services for Licensed Biological Materials
Genuine Cultures Emblem
Licensed Derivative Program
Biospecimen Management Agreement

2004 Release

Telomerase Licensing Agreement with Geron

2003 Releases
Aquatic Animal Conference Held
JHU and ATCC Form Collaboration
FDA Contract Awarded
New Facility Opens
Safe Deposit Service


Proficiency Standard Program Enlists MicroBioLogics, Inc.

August 5, 2008

ATCC (American Type Culture Collection) today announced that the Saint Cloud, Minnesota based MicroBioLogics, Inc. has joined the ATCC Proficiency Standard program.

MicroBioLogics, a leading manufacturer of quality control microbiology products, will use highly tested reference strains from ATCC in the proficiency test panels it provides to its customers worldwide. 


ATCC developed the Proficiency Standard program to provide authenticated microorganisms and other biological materials for use in the manufacture of laboratory proficiency test panels.

"A successful qualified, proven proficiency testing program begins with reference strains that are defined to the genus and species level. Adding MicroBioLogics to the ATCC Proficiency Standard Program underscores the importance of quality samples for proficiency testing," said Liz Kerrigan, ATCC's Director of Standards and Certification in Microbiology, Biodefense and Emerging Infections. “We are delighted to have the opportunity to work with MicroBioLogics. Both organizations are committed to ensuring that the global community has access to the highest quality materials for proficiency testing.”

Launched in October 2006, the ATCC Proficiency Standard program improves the laboratory proficiency testing (PT) system by raising the quality and consistency of the microorganisms and biological materials used in PT samples. In addition, the program improves laboratory safety by working with PT providers and manufacturers to qualify microorganisms for biosafety level before being included in a PT panel and providing traceability of the PT sample materials. ATCC proficiency test standard materials are produced specifically for the purpose of inclusion in proficiency test panels. They are tested for confirmation of identity, viability and purity, and each vial of material is individually labeled to allow full traceability from production to end-use.

“Successful performance in an external PT program is a key indicator of high laboratory quality,” said Robert C. Coborn, MicroBioLogics’ CEO. “ATCC contributes to valid PT programs by ensuring the authenticity of the sample materials.”
 
The ATCC Proficiency Standard program is available to proficiency test providers and manufacturers throughout the United States. Visit our Web page for information about other ATCC Standards programs or e-mail standards@atcc.org with your inquiries.

About MicroBioLogics, Inc.
 
MicroBioLogics, Inc. is a leading manufacturer of lyophilized microorganisms for quality control in microbiology laboratories world-wide specializing in clinical, industrial, food quality, environmental and educational markets. Headquartered in St. Cloud, Minnesota, the company has been providing laboratories across the globe with reference stock cultures and enumerated microorganism preparations of the highest quality for more than 35 years. As veterans of the industry they have achieved accreditation in accordance with ISO 17025:2005, ISO 9001:2000 certification, CE Mark Conformity, and are an FDA registered company. MicroBioLogics currently has more than 130 international distribution partners in over 100 countries.

 

ATCC Achieves Accreditation as a Reference Material Producer

May 13, 2008

ATCC today announced the accreditation of its biological material production and testing processes for ISO Guide 34:2000 — an international multi-industry standard specifically designed for producers of reference materials.
“The scope of ATCC’s ISO Guide 34 accreditation, which extends across a wide range of the organization’s processes for biomaterial production, is unprecedented in the biological sciences,” said Raymond Cypess, PhD/DVM, ATCC President and CEO. “Objective, third-party accreditation for ATCC production of bacteria, viruses, cell lines, mycology products and nucleic acids reaffirms ATCC’s commitment to quality products, customer service and continuous improvement.”
Authenticated biological materials from ATCC are widely used as reference strains for research and product testing. The availability of such biological standards enhances the validity, reliability and reproducibility of biotechnology research and development.
The inherent variability of biological materials brings unique challenges to establishing standards for in vitro model systems and to setting up ISO-compliant processes to produce them. Biological reference materials produced under an ISO Guide 34-accredited process have confirmed identity, well-defined characteristics and an established chain of custody — qualities essential to their effectiveness as biological standards in research and development.
ATCC Senior Director for Quality, Compliance and Biosafety Barry Waters, PhD, remarked, “ISO 34 accreditation represents an objective measure of confidence in the consistency and quality of ATCC reference cultures. It expands ATCC’s ability to produce internationally recognized standards for biological research and development, including certified reference materials (CRMs).”
The ISO Guide 34 standard for reference material producers is among those promulgated by the International Organization for Standardization (ISO), a network of national standards institutes from 157 countries. The organization operates a central secretariat located in Geneva, Switzerland to coordinate and administer the system. The ISO Guide 34 standard requires that the methods used to produce reference material are reproducible and controlled.
ATCC’s accreditation for ISO Guide 34 came from the independent ISO-accrediting organization American Association for Laboratory Accreditation (A2LA). A2LA is a private nonprofit membership society offering laboratory accreditation and training.
In late 2007, ATCC became certified in ISO 9001:2000, a widely known international standard for quality management systems. 

Innovative Biosensors Inc. and ATCC Partner to Develop High-Speed Test for Avian Flu 

April 9, 2008

Innovative Biosensors Inc. and ATCC today announced a research and development partnership aimed at developing a rapid and portable test to detect Avian (H5N1) influenza virus.
Under the agreement, ATCC will provide IBI with highly sensitive, proprietary monoclonal antibodies for H5N1 flu. IBI will use the reagents with their proprietary molecular technology platform to develop a rapid and accurate diagnostic test. The product will be commercialized and distributed through the IBI Environmental Group further expanding the menu of available assays according to Richard Thomas, President, IBI Environmental Group.
“IBI’s biosensor technology platform allows development of accurate and sensitive diagnostic tests that yield results in minutes,” said Dr. Cohava Gelber, ATCC Chief Scientific and Technology Officer.
The rapid Avian flu diagnostic test will depend on powerful ATCC technology for generating antibodies against specific antigens.  Joe Hernandez, President and CEO for IBI, remarked, “The combination of high-specificity ATCC monoclonal antibodies and IBI’s sensitive diagnostic platform will enable us to develop the first rapid and reliable test specific for Avian Flu virus.”
Innovative Biosensors, Inc. (IBI) of Rockville, Md. develops rapid, ultra-sensitive tests to identify harmful pathogens. ATCC (American Type Culture Collection), of Manassas, Va., is a global nonprofit biological resource center and research organization that acquires, authenticates, preserves, develops and distributes biological products for academic and industrial research.
Health professionals are concerned that the continued spread of a highly pathogenic avian H5N1 virus across eastern Asia and other countries represents a significant threat to human health. According to CDC, the H5N1 virus has raised concerns about a potential human pandemic because: it is especially virulent, it is spread by migratory birds, and it can be transmitted from birds to other mammals including humans. The recent cases of human disease form the basis for concerns of a potential pandemic due to sustained human-to-human virus transmission.


ATCC Gains ISO 9001:2000 Quality Management Systems Certification

January 22, 2008

ATCC (American Type Culture Collection) today announced its certification by BSI Management Systems, a leading international third-party accrediting body for ISO 9001:2000.
ISO 9001:2000 is an internationally recognized standard for quality management systems. The standard prescribes that key processes surrounding the provision of products and services are monitored to ensure that product quality objectives and customer needs are met.

The quality management systems standard is among those promulgated by the International Organization for Standardization (ISO), a network of national standards institutes from 157 countries. ISO operates a Central Secretariat located in Geneva, Switzerland to coordinate the system.

“Accreditation by a third-party organization for ATCC’s quality management system reaffirms the organization’s commitment to quality products, customer service and continuous improvement,” said Dr. Raymond Cypess, ATCC President and CEO.

In gaining ISO recognition, ATCC joins a pioneering group of biological product organizations with ISO certification. Biological materials authenticated and preserved by ATCC, such as cell lines and microorganisms, are widely used as reference materials for research and product testing.

“Across industries, ISO 9001:2000 certification is widely thought to correlate with efficient, effective operation and with customer satisfaction,” said Barry Waters, ATCC Senior Director for Quality, Compliance and Biosafety. 


ATCC Vero Cells Used to Manufacture a Second Rotavirus Vaccine for Clinical Trials

November 19, 2007
 

ATCC (American Type Culture Collection) announced today that its master cell bank of highly characterized Vero cells will be used for the manufacture of a second promising rotavirus vaccine candidate.

The rotavirus vaccine candidate was developed by Murdoch Childrens Research Institute (MCRI) in Victoria, Australia. ATCC Vero cells will be used as substrates to grow the rotavirus strain that is being used in the vaccine.

Several features make ATCC’s Vero master cell bank a desirable substrate for vaccine development and manufacture. The bank was started from Vero cells provided to ATCC in 1967, establishing a known pedigree and allowing full traceability. The deposit date is well before the FDA-established 1980 cut-off date for concern about the risk of bovine spongiform encephalopathy (mad cow disease) in materials used in vaccines. The cells were grown under current Good Manufacturing Practice (cGMP) conditions using fully traceable and documented culture reagents. At cell passage number 123, the bank ensures sufficient additional population doublings for manufacturing effective, high-titer vaccines.

“Since the ATCC Vero cells were developed and handled according to cGMPs, they offer an excellent mechanism to grow the virus and move the improved vaccine candidate through clinical trials,” said Professor Ruth Bishop of the Enteric Virus Group at Murdoch Childrens, group leader for the development of the new vaccine.

The rotavirus vaccine, RV3, is developed from a strain of the virus that conferred 100% protection against severe rotavirus disease among children infected naturally. This and other qualities made the strain a good vaccine candidate. While initial tests with the vaccine were promising, the current effort with the ATCC Vero cells is aimed at producing a higher-titer vaccine in the hope that it will elicit a greater immune response in future trials.

“The pedigree of the ATCC Vero cells, as well as their lower passage number, make them excellent components in vaccine development projects,” said Dr. Raymond Cypess, ATCC President and CEO. “We are proud to be involved with a study that could have such a profound positive impact on the health of the world’s children.”

Rotavirus infection is the leading cause of severe gastroenteritis in infants and young children worldwide. Annual deaths among children under five from rotavirus total close to 500,000, with most deaths occurring in resource-poor regions where the dehydration caused by the gastroenteritis combines with malnutrition to form a lethal pair.

The ATCC Vero cells are provided to Murdoch Childrens Research Institute as part of an agreement with the global health organization PATH. In February 2007, ATCC and PATH announced that ATCC’s Vero cells were selected for the manufacture of a separate rotavirus vaccine developed by National Institute of Allergy and Infectious Diseases (NIAID) scientist Dr. Albert Kapikian and colleagues.


ATCC Standards Development Organization Receives ANSI Accreditation

October 5, 2007
 

As a developer of industrial standards related to biological materials, ATCC will coordinate the drafting and revision of a series of voluntary consensus standards that will address laboratory testing and research protocols involving microorganisms, cell lines and other biological products, as well as standardization of the materials themselves.

ATCC is the first biological resource organization to garner ANSI accreditation as a standards development organization.

“There are major unmet needs for standards in academia, government and industries where biological materials are used in testing and R&D,” explained Dr. Raymond Cypess, President and CEO of ATCC. “ATCC is proud of its leading role in establishing consensus standards that will improve safety and productivity in industries where biomaterials are used, as well as in the wider scientific community.”

“ATCC’s function as a multifaceted resource for the scientific community, coupled with the recognition of many ATCC materials as reference standards, places the organization in an ideal position to spearhead development of voluntary consensus standards for biological research and testing,” explained Dr. Joseph Perrone, ATCC VP for Standards and Certification.

ANSI has managed efforts in voluntary consensus standards and conformity assessment activities since 1918, overseeing the creation, promulgation and use of thousands of norms and guidelines in almost every industrial sector. The Institute is the U.S. member of the International Organization for Standardization (ISO), as well as the International Electrotechnical Commission and a member of the International Accreditation Forum.

Accreditation by this body means that ATCC has constructed a process for generating standards that meet ANSI and other internationally recognized requirements for openness, balance and transparency among stakeholder groups, as well as due process for review and revision of the standard before it is adopted.

Since they are created under these requirements, voluntary consensus standards developed by an ANSI-accredited organization are highly valued by industry groups once they are approved by ANSI as American National Standards and adopted as common practice.
For more information on ATCC standards, click on the “Standards” button at www.atcc.org.


ATCC Proficiency Standard™ Program Enlists R&D Systems Inc.

July 11, 2007

ATCC (American Type Culture Collection) today announced that the Minneapolis-based firm R&D Systems Inc. has joined the ATCC Proficiency Standard program.

The agreement means that R&D Systems, a leading manufacturer of specialty biological products, will use highly tested reference cell lines from ATCC in the proficiency test panels it provides to its customers.

ATCC developed the Proficiency Standard program to provide authenticated microorganisms and cell lines for use in the manufacture of laboratory proficiency test panels.R&D

"Adding R&D Systems to the growing ranks of the ATCC Proficiency Standard Program underscores the importance of quality samples for proficiency testing," said Joseph Perrone, ScD, ATCC VP for Standards and Certification. "We are proud R&D Systems is involved in the program because it means the program is expanding."

Launched in October 2006, the ATCC Proficiency Standard program improves the laboratory proficiency testing (PT) system by raising the quality and consistency of the microorganisms and cell lines used in PT samples. In addition, the program improves laboratory safety by allowing traceability of the PT sample materials and working with PT providers and manufacturers to vet biological materials for biosafety level before being included in a PT panel.

ATCC proficiency test standard materials are produced specifically for the purpose of inclusion in proficiency test panels. They are tested for confirmation of identity, viability and purity, and each vial of material is individually labeled to allow full traceability from production to end-use.

"Successful performance in an external PT program is a key indicator of high laboratory quality," said Marcel Veronneau, Vice President, R&D Systems Hematology Operations. "ATCC contributes to valid PT programs by ensuring the authenticity of the sample materials."

Founded in 1976, R&D Systems Inc. produces over 10,000 products for academic and government research institutions, biotechnology and pharmaceutical companies, as well as hospitals, reference laboratories and blood banks that perform patient testing and monitoring for quality control.

The ATCC Proficiency Standard program is available to proficiency test providers and manufacturers throughout the United States. For more information, please visit the standards page at www.atcc.org or e-mail standards@atcc.org with your inquiries.

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ATCC Names CEDARLANE Exclusive Distributor in Canada
July 3, 2007

ATCC (American Type Culture Collection) today announced an agreement with CEDARLANE® Laboratories Limited, a Burlington, Ontario-based company, now the exclusive distributor of ATCC products in Canada and the newest member of ATCC's global network of distributors.

The agreement will improve access to ATCC products for the Canadian academic, industrial R&D and quality control testing communities by facilitating the ordering process as well as streamlining logistics for shipping and customer service. Benefits include expedited import paperwork and the ability to purchase products with Canadian currency.

"The ATCC-CEDARLANE agreement gives Canadian researchers and quality control professionals even greater access to the many ATCC Genuine Cultures® that are used in their laboratories," said Michael Gove, ATCC VP for Sales and Marketing. "CEDARLANE's focus on customer service and quality products makes them a perfect fit to represent ATCC in Canada."

CEDARLANE will distribute ATCC Genuine Cultures®, many of which are cited as biological reference materials in standard research and testing protocols. Cited ATCC reference materials and standards can be searched with the Web-based ATCC Standards Resource™. In addition to cultures, CEDARLANE will distribute ATCC high-performance media, sera, genomic DNA and other products in Canada.

In business since 1957 and incorporated in 1975, CEDARLANE is a 100% Canadian Corporation and a leading supplier of research reagents in Canada and worldwide. The company is ISO 9001:2000 accredited and ISO 13485 certified.

Key components of the CEDARLANE mission are to provide quality products, assure customer satisfaction and respond to the changing needs of the research community.

"CEDARLANE is proud to add ATCC products to its extensive portfolio," said Cynthia Greer, CEDARLANE President. "Canadian scientists have an even greater opportunity to consolidate ordering from a long list of high-quality suppliers of scientific products."

For more information on ordering ATCC products through CEDARLANE, visit their website.

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ATCC® Scientists Uncover Novel Biomarkers for Type 2 Diabetes
June 25, 2007

ATCC (American Type Culture Collection) today announced that scientists at the organization have identified novel biological markers for type 2 diabetes.

The multidisciplinary ATCC team mapped proteins and patterns of gene expression in animal (rat) models of human type 2 diabetes, and uncovered 27 proteins that were expressed at different levels in healthy and diabetic rats. Of those, six proteins linked to diabetes resistance and sensitivity had not been described previously.

By analyzing gene expression levels, the scientists found patterns that differed depending on how far the disease had progressed, opening the possibility that these expression patterns could serve as indicators for predisposition to and development of type 2 diabetes.

"ATCC takes an integrated approach to biomarker discovery, using genomics, proteomics and immunology," said Dr. Cohava Gelber, ATCC Chief Science and Technology Officer. "The work by the ATCC team is a wonderful example of translational research that highlights another way ATCC promotes the discovery of reagents and medicines, and advances science for the benefit of the research community and the general public."

Diabetes — an impaired ability to produce or properly use the hormone insulin to convert sugars and starches into energy — increases the risk for other serious health problems, such as cardiovascular disease, blindness and damage to the kidneys and nerves. Early signs of diabetes include elevated blood glucose levels (pre-diabetes).

Treatment early in the progression of the disease can postpone or prevent diabetes, but few of the estimated 54 million pre-diabetics in the U.S. are identified and treated because no simple laboratory test exists to assess an individual's risk of developing diabetes. The work by the ATCC team could help assess diabetes risk and prevent future complications.

In the biomarker studies, the ATCC researchers used Cohen Diabetic (CD) rats, which manifest many common clinical features of human type 2 diabetes. They examined protein expression in pancreas tissue, serum and epididymal fat from rats, as well as in serum proteins from diabetic patients. The differentially expressed proteins found by the ATCC team are associated with a host of physiological processes, such as inflammation, insulin signaling and lipid metabolism.

ATCC has filed an application for an international patent involving the diabetes biomarkers under the Patent Cooperation Treaty.

In addition to diabetes, research teams at ATCC are developing biomarkers and methods of use for other major chronic health problems, such as lung, pancreatic and colon cancers.

ATCC scientists presented posters about the biomarkers at the American Diabetes Association Scientific Sessions meeting in Chicago in June and will present the research at the European Association for the Study of Diabetes conference in Amsterdam in September.

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ATCC® Launches SafeTsource™ Non-Animal Origin Microbial Products
May 23, 2007

ATCC (American Type Culture Collection) today launched SafeTsource™, a set of non-animal origin microbial products that can be used in a wide variety of applications where the presence of animal-derived products are of concern.

The SafeTsource product line includes microbial cultures, growth media and a cryoprotectant agent. They are applicable for quality control testing where products are manufactured using aseptic processing.

SafeTsource microorganisms are grown on vegetable-based media and freeze-dried without contacting animal-derived materials.

All SafeTsource cultures originate from pre-1980 seed stocks, meaning they are known to have been preserved at ATCC prior to the date cited in FDA-issued guidance regarding the risk of bovine spongiform encephalopathy (BSE).

The SafeTsource product line comprises 17 bacteria species, two yeasts and one fungus species. The group includes several strains commonly used as reference materials for industry QC testing, including Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Aspergillus niger and Candida albicans.

The SafeTsource product line also includes non-animal origin tryptic soy broth culture media and a cryoprotectant agent.

Microbial growth characteristics and phenotypic features have been shown to be maintained when growing cultures on non-animal origin media. (Cleland D, Jastrzembski K et al. Growth characteristics of microorganisms on commercially available animal-free alternatives to tryptic soy medium. Journal of Microbial Methods. 69: 345-352. 2007.)

More information on SafeTsource products can be found on our website.

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ATCC Proficiency Standard™ Program Enlists Swiss Center for Quality Control
May 17, 2007

ATCC (American Type Culture Collection) today announced that the Switzerland-based proficiency test provider Centre Suisse de Contröle de Qualité (CSCQ) has joined the ATCC Proficiency Standard program.

The agreement means that CSCQ will use highly tested reference microorganisms from ATCC in the proficiency test panels it provides to its customers.

ATCC developed the Proficiency Standard program to provide authenticated microorganisms and other biological materials for use in the manufacture of laboratory proficiency test panels.

"Adding CSCQ to the growing ranks of the ATCC Proficiency Standard Program underscores the importance of quality samples for proficiency testing," said Joseph Perrone, ScD, ATCC VP for Standards and Certification. "We are proud CSCQ is involved in the program because it means the program is expanding globally."

Launched in October 2006, the ATCC Proficiency Standard program improves the laboratory proficiency testing (PT) system by raising the quality and consistency of the microorganisms and biological materials used in PT samples. In addition, the program improves laboratory safety by allowing traceability of the PT sample materials and working with PT providers and manufacturers to vet microorganisms for biosafety level before being included in a PT panel.

ATCC proficiency test standard materials are produced specifically for the purpose of inclusion in proficiency test panels. They are tested for confirmation of identity, viability and purity, and each vial of material is individually labeled to allow full traceability from production to end-use.

"Successful performance in an external PT program is a key indicator of high laboratory quality," said Dr. Andre Deom, Director of CSCQ. "ATCC contributes to valid PT programs by ensuring the authenticity of the sample materials."

The nonprofit organization CSCQ provides proficiency tests to more than 5000 laboratories in Switzerland and other European countries. CSCQ is also a World Health Organization (WHO) collaborating center for quality assurance.

The ATCC Proficiency Standard program is available to proficiency test providers and manufacturers throughout the United States. For more information, please visit the standards page at www.atcc.org or e-mail standards@atcc.org with your inquiries.

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ATCC Proficiency Standard™ Program Enlists College of American Pathologists (CAP)
April 12, 2007

ATCC (American Type Culture Collection) today announced that the College of American Pathologists Proficiency Testing program has joined the ATCC Proficiency Standard program.

The agreement means that the College of American Pathologists Proficiency Testing program will use highly tested reference microorganisms from ATCC in proficiency test panels it provides to its customers. ATCC developed the Proficiency Standard program to provide authenticated microorganisms and other biological materials for use in the manufacture of laboratory proficiency test panels.

"Adding the College of American Pathologists Proficiency Testing program to the growing ranks of the ATCC Proficiency Standard Program underscores the importance of quality samples for proficiency testing," said Joseph Perrone, ScD, ATCC VP for Standards and Certification. "We are proud the College of American Pathologists is involved in the program because they represent a history of quality and leadership in proficiency testing in the United States and globally."

Launched in October 2006, the ATCC Proficiency Standard program improves the laboratory proficiency testing (PT) system by raising the quality and consistency of the microorganisms and biological materials used in PT samples. In addition, the program improves laboratory safety by allowing traceability of the PT sample materials and working with PT providers and manufacturers to vet microorganisms for biosafety level before being included in a PT panel.

ATCC proficiency test standard materials are produced specifically for the purpose of inclusion in proficiency test panels. They are tested for confirmation of identity, viability and purity, and each vial of material is individually labeled to allow full traceability from production to end-use.

"Successful performance in an external PT program is one of the key indicators of laboratory quality," said Thomas M. Sodeman MD, President of the College of American Pathologists. "The ATCC program helps to ensure the authenticity of the materials used in sample materials."

The ATCC Proficiency Standard program is available to proficiency test providers and manufacturers throughout the United States. Visit our Web page for information about other ATCC Standards programs or e-mail standards@atcc.org with your inquiries.

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ATCC Proficiency Standard™ Program Enlists American Proficiency Institute
March 20, 2007

ATCC (American Type Culture Collection) today announced that the American Proficiency Institute (API) has joined the ATCC Proficiency Standard program.

The agreement means that API will use highly tested reference microorganisms from ATCC in the proficiency test panels it provides to its customers. ATCC developed the Proficiency Standard program to provide authenticated microorganisms and other biological materials for use in the manufacture of laboratory proficiency test panels.

"Adding API to the growing ranks of the ATCC Proficiency Standard program underscores the importance of quality samples for proficiency testing," said Joseph Perrone, ScD, ATCC VP for Standards and Certification. "We are proud API is involved in the program because of their track record of top-notch proficiency testing service in hospitals, physician offices and in the food industry."

Launched in October 2006, the ATCC Proficiency Standard program improves the laboratory proficiency testing (PT) system by raising the quality and consistency of the microorganisms and other biological materials used in PT samples. The program improves laboratory safety by allowing traceability of the PT sample materials. In addition the program involves ATCC working with PT providers and manufacturers to vet microorganisms for biosafety level before being included in a PT panel.

ATCC proficiency test standard materials are produced specifically for the purpose of inclusion in proficiency test panels. They are tested for confirmation of identity, viability and purity, and each vial of material is individually labeled to allow full traceability from production to end-use.

"Successful performance in an external PT program is a key indicator of high laboratory quality," said API President Daniel Edson. "ATCC contributes to valid PT programs by ensuring the authenticity of the sample materials."

API provides innovative solutions and technical excellence to nearly 14,000 clinical laboratories. API also offers a unique PT program for the food industry. For more information, visit www.api-pt.com.

The ATCC Proficiency Standard program is available to proficiency test providers and manufacturers throughout the United States. Visit our Web page for information about other ATCC Standards programs or e-mail standards@atcc.org with your inquiries.

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ATCC Vero Cells Supplied For Rotavirus Vaccine Commercialization
February 13, 2007

ATCC (American Type Culture Collection) today announced a licensing agreement with the global health nonprofit organization PATH to provide a master cell bank of highly characterized ATCC Vero cells for use in developing and manufacturing a new type of rotavirus vaccine.

Master banks of Vero cells are used in vaccine manufacturing to grow viruses specially designed to elicit an immune response to infectious agents such as rotavirus.

Rotavirus is the most common cause of severe gastroenteritis in infants worldwide, causing half a million deaths and more than 2 million hospitalizations a year in children under 5 years of age. Children in the poorest countries consistently account for more than 90 percent of rotavirus deaths. Because access to medical care is limited in developing countries, the most effective strategy to reduce the toll of rotavirus disease is prevention through vaccination.

A UK Bovine Human Reassortant vaccine developed by National Institute of Allergy and Infectious Diseases (NIAID) scientist Dr. Albert Kapikian and colleagues specifically targets rotavirus strains common in lower-income countries. NIH has recently licensed the virus strains for this vaccine to eight manufacturers for vaccine development and introduction. PATH is providing technical support to the manufacturers in order to help accelerate development of safe, effective, and affordable vaccines for the developing world. The ATCC Vero cells will be a key component in the production of a rotavirus vaccine.

Several features make ATCC's Vero master cell bank a desirable substrate for vaccine development and manufacture. The bank was started from Vero cells provided to ATCC in 1966, establishing a known pedigree and allowing full traceability. The deposit date is well before the FDA-established 1980 cut-off date for concern about the risk of bovine spongiform encephalopathy (mad cow disease) in materials used in vaccines. The cells were grown under current Good Manufacturing Practice (cGMP) conditions using fully traceable and documented culture reagents. At cell passage number 123, the bank ensures sufficient additional population doublings for manufacturing effective, high-titer vaccines.

ATCC is proud to contribute to this global health effort," ATCC President and CEO Dr. Raymond Cypess remarked. "As part of ATCC's commitment to translational research by extending the use of its cultures to clinical applications, we will work to provide Vero cells to the wider vaccine development community for future vaccine projects."

"The ATCC Vero master cell bank is an invaluable resource for vaccine production," said Rajat Goyal, project director for PATH's Advancing Rotavirus Vaccine Development Project. "ATCC's involvement in PATH's rotavirus program will help address a pressing global health issue in the places where it hits hardest." For more information, contact Scott Jenkins at sjenkins@atcc.org.

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ATCC Launches New Quality Control Testing Tool — Authenticult™
February 6, 2007

ATCC announced the availability of Authenticult™, a new quality control microbiology testing tool that offers ATCC Genuine Cultures® in convenient, easy-to-use packaging.

The self-contained Authenticult packaging contains a lyophilized microorganism pellet, a reservoir of hydrating fluid and an inoculating swab.

The initial launch of Authenticult encompasses sets of microorganisms for use with the bioMérieux VITEK® Legacy microbial identification system. View the list of available QC sets.

In the future, additional sets for QC of microbial identification systems will be made available.

To ensure thorough characterization of every strain, Authenticult products are quality controlled utilizing a polyphasic approach that incorporates traditional biochemical methods, as well as automated phenotypic testing and genotypic analysis.

In the United States, Authenticult products are available directly from ATCC, and internationally through ATCC authorized distributors.

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ATCC Proficiency Standard™ Program Enlists American College of Physicians
January 29, 2007

ATCC (American Type Culture Collection) announced that the Medical Laboratory Evaluation division of the American College of Physicians (ACP) has joined the ATCC Proficiency Standard program, which provides authenticated microorganisms and other biological materials for use in the manufacture of laboratory proficiency test panels.

The agreement means that ACP will use highly tested reference microorganisms from ATCC in the proficiency test panels it provides to clinical laboratories.

"The addition of ACP to the ATCC Proficiency Standard program has major significance because it indicates that leading physicians embrace the concept of using well-characterized biological materials in proficiency testing," said Joseph Perrone, ScD, ATCC VP for Standards and Certification.

ACP is the nation's largest medical specialty society, with a membership of around 120,000 physicians in general internal medicine and related subspecialties, including cardiology, gastroenterology, nephrology, endocrinology, hematology, rheumatology, neurology, pulmonary disease, oncology, infectious diseases, allergy and immunology, and geriatrics. Its mission is to enhance the quality and effectiveness of health care by fostering excellence and professionalism in the practice of medicine.

The ATCC Proficiency Standard program is available to proficiency test providers and manufacturers throughout the United States. Visit our Web page for information about other ATCC Standards programs or e-mail standards@atcc.org. with your inquiries.

About ACP
The American College of Physicians is the largest medical specialty organization and the second-largest physician group in the United States. ACP members include 120,000 internal medicine physicians (internists), related subspecialists, and medical students. Internists specialize in the prevention, detection and treatment of illness in adults. www.acponline.org.

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ATCC Standards Resource™ Boosted By Support From CLSI
October 23, 2006

A collaboration between ATCC and the Clinical and Laboratory Standards Institute® (CLSI, formerly NCCLS) greatly enhances the usefulness and value of ATCC's Web-based standards resource to both CLSI members and other laboratory scientists in need of standard test methods.

This collaboration enhances the ATCC Standards Resource, providing mutual customers of the two organizations with rapid access to cross-referenced information about widely used microbiology test methods and laboratory procedural standards from CLSI that cite ATCC products.

Part of the wider ATCC standards program, the Web-based resource is a searchable database of standard test methods and commercial assays that is linked to information on ATCC's collection of reference cultures. The search tool allows scientists and laboratory professionals to determine which ATCC-held bacteria, viruses, fungi or cell lines are specified in CLSI standards.

"CLSI's participation with the ATCC Standards Resource makes up-to-date information on a wide range of CLSI documents easily available," said Joseph Perrone, ScD, Vice President for the Standards Program at ATCC.

"Websites for the two organizations will be conveniently linked so that users can quickly find and purchase procedural standards and the ATCC biological reference materials needed to carry out those standards," Perrone added.

ATCC cultures are commonly used as standard controls in areas as diverse as clinical laboratory testing, environmental monitoring and pharmaceutical development. They are also used widely in biological testing for industrial-scale manufacturing of foods, beverages, textiles, paint, cosmetics and personal care products.

Users of the ATCC Standards Resource can enter a specific CLSI standard and the Web tool will return information about the ATCC reference materials necessary for carrying out that procedure. The search tool can be accessed through ATCC's website.

"With ATCC and CLSI working together, there will be mutual benefits for clinical laboratory scientists in a host of fields in which microorganisms are used for testing," said CLSI Executive Vice President, Glen Fine.

For over 80 years, ATCC has played a key role in the area of standards. ATCC uses meticulous characterization and preservation methods that maintain reference materials in a manner that permits reproducibility of results across time and among laboratories around the world.

About CLSI
Clinical and Laboratory Standards Institute® (CLSI, formerly NCCLS) is a global, nonprofit organization whose vision is to be the leader in clinical and laboratory standards to improve the quality of medical care. Established in 1968, CLSI's mission is to develop best practices in clinical and laboratory testing and promote their use throughout the world, using a consensus-driven process that balances the viewpoints of industry, government, and the healthcare professions. For more information on CLSI and its global efforts in standardization, visit us online at www.clsi.org.

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ATCC Launches Laboratory Proficiency Testing Standards Program
October 10, 2006

In April 2005, nearly 4,000 proficiency test panels sent to clinical laboratories were recalled because they contained an influenza virus H2N2 subtype to which a large portion of the human population has no immunity. While the reasons for its inclusion in the panels are complex, the H2N2 virus posed significant public health risks had the test panels been mishandled by laboratory technicians.

The H2N2 recall illustrates the importance of using traceable and properly characterized microorganisms in proficiency panels in response to these critical health system risks. ATCC® (American Type Culture Collection) has developed the Proficiency Standard program to provide authenticated bioreagents for use in the manufacture of laboratory proficiency test panels.

"The public health ramifications of the H2N2 scare prompted ATCC to find a way to offer to the proficiency testing system its expertise in handling, storing, authenticating and distributing microorganisms," said Joseph Perrone, ATCC Vice President for Standards & Certification. "Laboratory personnel are not properly informed about the microbes they are handling in proficiency panels and therefore cannot know the full safety implications. Laboratory directors and technicians should always ask themselves, 'Where do my test panel's microbes come from?'"

Under current practices, microorganisms in proficiency panels are often subjected to excessive subculturing, have unknown pedigrees, and are misidentified, contaminated or stored under variable conditions. These factors can degrade the quality of the proficiency testing system or expose lab personnel to undue hazards.

The program improves the current situation in four ways. First, ATCC will work with proficiency test providers and manufacturers to select strains for the panels prior to manufacture, ensuring that microorganisms are vetted for appropriate biosafety level before they are sold. Second, the program prevents contamination and misidentification by testing the sample microbes' authenticity. Third, to improve year-to-year consistency, manufacturers will acquire new strains each year and destroy remaining material when panel assembly is complete. Fourth, serial numbers on each vial allows microbes to be traced individually.

"The ATCC Proficiency Standard program will improve the validity and safety of proficiency testing by using characterized reference microbes in test panels," said Perrone, adding, "Authenticated microorganisms bring consistency to the tests and allow results to be meaningfully compared among a group of laboratories." These features are absent if such reference material is not available for the panels and clinical isolates are used instead.

The ATCC Proficiency Standard program is now available to proficiency test providers and manufacturers throughout the United States. For more information, please visit the standards page on our website or e-mail standards@atcc.org.

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ATCC Announces 2007 Cell Biology Catalog
October 3, 2006

ATCC announced the release of the 2007 Cell Biology Catalog. The new catalog highlights the 3,600 cell lines and hybridomas that comprise the ATCC cell biology collection as well as the high-performance media, sera and reagents used to culture ATCC cell lines.

A guide to navigating the ATCC website is featured and an expanded technical section has been included to punctuate the usefulness of the catalog. Additional features include indexes that organize the cell biology collection by species of origin, tissue source, disease type and other traits allowing for user-friendly searching.

The 2007 Cell Biology Catalog, when used in conjunction with the website, gives researchers comprehensive information about ATCC's authenticated, low-passaged cell lines, which are fully-tested against contamination, misidentification and genetic instability. To request a copy of this resource, use the sign-up form on this website.

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ATCC Licensed Derivative Program Expands with Addition of Remel Inc.
August 24, 2006

ATCC® today announced the addition of Remel Inc. to the ATCC Licensed Derivative® (LD) program. The new agreement with Remel — a leading global provider of premium-quality microbiology products — strengthens the LD program and further benefits the global diagnostic and analytical testing markets.

Launched by ATCC in June 2005, the LD program allows confirmation of the identity, viability and purity of microbes contained in commercial microbiology products. Quality-control professionals as well as consumers are assured that products bearing ATCC's Licensed Derivative emblem contain microorganisms tested by ATCC to confirm they are viable, pure and accurately identified.

"Remel's addition to the ATCC Licensed Derivative program marks an important step in the evolution of this vital initiative," said ATCC President and CEO Raymond Cypess, DVM/PhD. "Remel's strong position in the global marketplace will greatly support ATCC's mission to help provide the QC microbiology community with products for which the identity and purity of ATCC-derived microorganisms are assured."

Remel's broad portfolio of trusted, market-leading brand names, combined with its extensive manufacturing and distribution capabilities, will further promote the objectives of ATCC's LD program. "Remel is deeply rooted in the marketplace and it is imperative that our products are properly handled and utilized to ensure their integrity and performance," said Rodney Smith, president and general manager of Remel Inc. "This program supports standards for quality control and further extends our commitment to help make the world a safer place."

"Remel's participation greatly reinforces the importance of setting and regulating quality control standards," Jesus Soriano, MD/PhD/MBA, ATCC Vice President for Licensing, Contracts and Compliance remarked. "Because of the magnitude of Remel's support system, the Licensed Derivative program will continue to expand as more professionals become aware of the positive impact verified LD microorganisms have on the validity of microbiology testing."

About Remel
Remel is a global provider of a wide range of high quality microbiology products used by clinical, industrial, research, and academic laboratories. Remel is a world leader in the manufacture and distribution of dehydrated and prepared culture media, collection and transport systems, diagnostic and rapid direct specimen tests, quality control products and much more. An extensive product portfolio, which includes trusted, market-leading brand names and superior product performance, is complemented by a team of experts dedicated to providing the highest levels of technical support and customer service. For more information about Remel or its products, visit www.remel.com or call 800-255-6730.

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ATCC Adds Mecconti to its Microbiology Products Quality Program
August 14, 2006

ATCC® announced today the addition of Luxembourg-based microbiology firm Mecconti s.a.r.l. to the ATCC Licensed Derivative® program, an initiative aimed at improving the quality of microbiology products and protecting consumers impacted by them.

The license agreement between ATCC and Mecconti represents a major expansion of ATCC's Licensed Derivative (LD) program for European quality control professionals and consumers.

The LD program assures QC microbiologists that commercial products bearing the LD emblem contain microorganisms with confirmed identity, viability and purity.

For-profit companies who claim to incorporate ATCC biomaterials into their own commercial products but are not part of the LD program do not comply with ATCC's quality controls and often violate ATCC's material transfer agreement. Any claims made by the companies about the equivalence of the microorganisms in their products directly to ATCC strains are unsubstantiated because ATCC does not test them.

ATCC VP for Licensing, Contracts and Compliance Dr. Jesus Soriano said "Quality control professionals need to know with certainty that the materials at the foundation of their testing are viable, pure and correctly identified. By purchasing materials that carry the Licensed Derivative emblem, customers can trust that the characteristics of the ATCC-derived microorganisms have been maintained and confirmed until they reach the end users."

"As a public science organization, ATCC takes very seriously our responsibility to try to ensure the safety and quality of the materials we provide," Soriano added.

"In joining ATCC's effort and passing their rigorous evaluation of our quality control process, our customers can be assured that our family of microorganisms is derived directly from ATCC cultures and is controlled to maintain its identity, purity and viability in products used in the industrial, clinical or environmental setting," Mecconti President Dr. Gerhard Huecker said.

ATCC is the world's largest biological resource center and the most comprehensive source of standard reference cultures and reagents used by life science researchers in academic, government and industrial laboratories.

Mecconti develops freeze-dried microorganism products and dehydrated culture media for use in quality control testing of pharmaceutical, biotech and food/beverage products manufactured around the world.

About Mecconti
Although founded in 2004, MECCONTI already has become one of the leading European suppliers for high quality products used in microbiological laboratories of the food, pharmaceutical and environmental industry, as well as in health care facilities. Its products are sold through a network of national distributors in all European countries. MECCONTI's mission is to serve industry with state-of-the-art products and services, which enable end users to concentrate on their original business. Visit us at www.mecconti.com.

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Miclev Settles Trademark Lawsuit with ATCC
Swedish Diagnostics Company Agrees to Comply with ATCC's Specifications
May 24, 2006

Miclev, a company that supplies the Scandinavian market with biotech diagnostic tests, has settled a trademark infringement lawsuit filed against it by U.S.-based ATCC over the misuse of the trademark ATCC®.

In its lawsuit ATCC charged that Miclev, without ATCC's consent, improperly used the mark ATCC in marketing and sales of Miclev's microorganisms.

Under the terms of the settlement, Miclev must join and comply with ATCC's Licensed Derivative Program if it uses the ATCC Licensed Derivative® emblem and Catalog Marks. ATCC created its Licensed Derivative Program to ensure that its microorganisms — which are resold and used worldwide by hundreds of laboratories, universities and companies —are not altered or compromised in any way. ATCC's program assures consumers that microorganisms found in products carrying this emblem meet ATCC's world-renowned standards for quality and safety.

"This legal action and subsequent settlement demonstrates that ATCC will aggressively pursue with all the means at our disposal any organization in the world that risks the integrity of our brand and the safety of the public by using ATCC microorganisms improperly," said Dr. Jesus Soriano, ATCC's Vice President of Licensing, Contracts and Compliance. "It is unfortunate, but imperative that we take such action in order to try to protect the consumers around the world who are using ATCC microorganisms every day."

ATCC, also known as American Type Culture Collection, is the world's largest biological resource center and the most comprehensive source of reference cultures and reagents used by researchers in academic, government and industrial laboratories.

By joining the ATCC Licensed Derivative® Program, companies agree to maintain the integrity of the ATCC ingredient contained in their product and allow ATCC to verify the identity of that ATCC ingredient before it reaches end users. The ATCC Licensed Derivative™ emblem is the symbol that signifies that ATCC ingredients in ATCC-derived products are endorsed by the organization. Without the emblem, customers lack ATCC's assurance that the microbial strains contained in quality control products have been handled according to ATCC's specifications.

Since 1925, ATCC has set the standard for authenticating and distributing biological materials for life science research in the public and private sector. ATCC's mission is to acquire, authenticate, preserve, develop, and distribute biological materials, information, technology, intellectual property, and standards for the advancement, validation, and application of scientific knowledge. Located in Manassas, Virginia, ATCC operates as a not-for-profit biological resource center, providing biological materials for use under the terms of a material transfer agreement (MTA).

While ATCC assures the authenticity of biomaterials and research tools provided by itself and its exclusive distributors, the organization cannot do the same in situations where for-profit companies have incorporated ATCC biomaterials into their own commercial products, a practice that lies outside the scope of the MTA. In those situations, ATCC does not have a relationship with the product's seller, making it impossible to vouch for the identity of the ATCC materials as they are applied in their final form.

Miclev supplies the Scandinavian market with diagnostic products for industrial microbiology and contamination control. It serves the pharmaceutical and biotechnology industries as well as other laboratories in Sweden, Denmark, Norway and Finland.

"We welcome Miclev as a member of ATCC's Licensed Derivative Program and we are happy we were able to resolve this litigation in a way that satisfies the needs of both our companies," Dr. Soriano said. "But most important, this settlement helps safeguard the health and well-being of consumers around the world." For more information, contact Intellectural Property and Asset Management Office at licensing@atcc.org.

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ATCC Launches Web-Based Standards Search Tool
May 22, 2006

ATCC® (American Type Culture Collection) announced today the launch of a searchable Web-based resource for cross-referencing ATCC strains with a database of widely used and agreed-upon test methods and laboratory procedural standards.

Part of the ATCC Standards Program, the Web-based resource is a searchable database of standard microbiology test methods and commercial assays that is linked to information on ATCC's collection of reference microorganisms. The search tool allows scientists and laboratory professionals to determine which ATCC-held bacteria, viruses, fungi or cell lines are specified in a particular standardized test method or procedure.

"This standards resource will be a tremendous help for communities of scientists in clinical laboratories, pharmaceutical development, quality control microbiology and a host of other fields in which microorganisms are used for testing," said Joseph Perrone, ScD, Vice President for the Standards Program at ATCC. "Users can quickly and easily find information about high-quality ATCC reference materials that are used in a wide range of tests and protocols."

ATCC cultures are commonly used as standard controls in areas as diverse as clinical laboratory testing, environmental monitoring and pharmaceutical development. They are also used widely in microbiology testing for industrial-scale manufacturing of foods, beverages, textiles, paint, cosmetics and personal care products. Professional organizations and government agencies draft procedural standards for microbiology assays and tests that often specify the use of particular ATCC strains.

For example, ATCC strains are cited in agreed-upon standard protocols for testing the efficacy of an antibiotic or cleaning technique such as handwashing or steam sterilization. They are also used as controls when testing for the ability of a product, such as paint or preserved lumber, to resist microbial attack. Other ATCC materials are cited in standard procedures for microbe identification.

Users of the ATCC Standards Resource can enter a specific protocol that has been established as a consensus standard. The standards resource will return information about the ATCC reference materials necessary for carrying out that standard procedure. Alternatively, persons can search for a particular ATCC standard reference microorganism and view all standards-related information associated with that material.

Standards resource users can search standard test methods by name or number of the organization or company that developed it, or by the number of the test that calls for ATCC strains. They can access product page descriptions for the cultures specified. The Web-based standards resource can be accessed through the ATCC Web site.

For over eighty years, ATCC has played a key role in the area of standards. ATCC uses meticulous characterization and preservation methods that maintain reference materials in a manner that permits reproducibility of results across time and among laboratories around the world.

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Biodefense Expert Summit Sets Stage For Standards Development
April 6, 2006

Some of the world's leading biodefense research and development leaders took a major step today toward establishing consensus standards for biodefense-related materials and processes during an exclusive summit convened by ATCC.

The distinguished group of experts established a foundation for future biodefense standards by cultivating agreement on a set of key questions and issues that will need to be addressed as the biodefense community develops standards.

The ATCC Expert Panel on the Development of Standards for Biodefense brought together academic, industry and government stakeholders from across the country to address the glaring need for standards in the biodefense community.

"Establishing standards brings validity to research efforts, and is absolutely critical for sustained research progress and accelerated product development in biodefense," said meeting chair Joseph Perrone, VP for Standards and Certification at ATCC. "The depth and breadth of experience and expertise brought to bear by the panelists and attendees at the conference bode well for our ultimate goal of filling the gap that now exists in the area of standards for biodefense."

Meeting attendees discussed those key biological materials, reagents and handling protocols that, if standardized, would have the most profound impact on biodefense research and product development. Biodefense standards are necessary to assure adherence to industry guidelines, maintain R & D best practices and promote public safety.

"This meeting had profound importance to the effort toward biodefense standards because it provided a common launching point and to a large extent mapped the way forward for members of the various stakeholder communities," Perrone asserted, adding, "Discussion during this meeting went a long way toward determining how standards should be developed for organizations involved in the development, authentication, storage, handling and transfer of materials used in biodefense R & D," Perrone added.

The future path toward comprehensive biodefense standards will involve additional meetings that incorporate a wider group of stakeholders. Once the key issues have been parsed out, voluntary consensus standards will be written for use in the biodefense industry and research community.

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ATCC Licensed Derivative® Program Expands Worldwide Reach with Addition of Gibson Labs
March 8, 2006

ATCC announced today the addition of Kentucky-based Gibson Laboratories, Inc. to the ATCC Licensed Derivative® (LD) program. With the Gibson agreement, the LD program now benefits thousands of quality control professionals who use commercial microbiology products at hospitals and laboratories in 36 countries.

Launched by ATCC in June 2005, the LD program establishes a mechanism to confirm the identity, viability and purity of microbes contained in commercial microbiology products sold by members of the program. Quality control professionals as well as consumers are assured that products bearing ATCC's Licensed Derivative emblem contain microorganisms tested by ATCC to ensure they are viable, pure and accurately identified.

Gibson Laboratories, an established provider of microbiology supplies, is the third company to join the ATCC Licensed Derivative program in recent months. The other companies involved in the program are Minnesota-based MicroBioLogics Inc., which joined in June 2005, and Quality Technologies LLC of California, a member since November 2005.

"We are delighted that Gibson has joined the roster of LD program firms," Jesus Soriano, MD/PhD, ATCC Vice President for Licensing, Contracts and Compliance remarked. "The reach of the Licensed Derivative program is expanding, and professionals responsible for microbiology testing have more of an opportunity than ever to take advantage of the extra confidence that comes with the verified microorganisms in LD products."

To learn more about Gibson Laboratories, visit: www.gibsonlabs.com.

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ATCC Licensing Program Aids Genmab Drug Development
January 6, 2006

ATCC® announced today the signing of a license agreement with Genmab A/S that supplies the biotechnology firm with an ATCC cell line standard for drug in vitro consistency studies.

The worldwide, nonexclusive Genmab agreement is the latest in a series of commercial licensing arrangements that enable highly characterized ATCC biological materials to be used for a variety of industrial R & D purposes.

Genmab A/S develops human antibodies for the treatment of a wide range of diseases, including cancer, infectious disease and autoimmune disorders.

The ATCC-Genmab agreement will allow the biotech firm to employ an ATCC cell line standard in testing the potency of manufacturing batches of human monoclonal antibodies that the company is developing. The assays will be used with Genmab antibodies designed to recognize specific cell surface receptors.

"ATCC is delighted to have the chance to provide our biomaterials to Genmab as they navigate the final stages of drug development," said ATCC VP for Licensing, Contracts and Compliance Jesus Soriano, MD/PhD. "Arrangements such as the one between ATCC and Genmab reflect ATCC's willingness to address the increasing demand for commercial use of ATCC biological standards."

ATCC's nonexclusive licensing program ensures equitable access to reference research materials that are otherwise available under the ATCC Material Transfer Agreement, a contract that limits the use of ATCC biomaterials to noncommercial scientific research.

About Genmab A/S
Genmab A/S is a biotechnology company that creates and develops human antibodies for disease treatment. Genmab has numerous products in development to treat cancer, infectious disease, rheumatoid arthritis and other inflammatory conditions. At present, Genmab has multiple partnerships to gain access to disease targets and develop novel human antibodies. Genmab has operations in Denmark, the Netherlands and the U.S. For more information, visit: www.genmab.com.

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ATCC Awarded Contract For NCI Biospecimen Network Program
November 7, 2005

The American Type Culture Collection (ATCC®) announced today its award of a contract from the National Cancer Institute to design and implement a system to collect and store biological specimens and associated clinical data for use in cancer research. The NCI project's ultimate goal is to enhance the quality and availability of clinical biospecimens and associated data to the broader scientific community.

The contract award allows ATCC to apply its core competencies in the acquisition, authentication, preservation, storage and distribution of biological reference materials to managing clinical biospecimens for cancer researchers.

The contract represents a significant part of NCI's biospecimen network pilot program, aimed at speeding the discovery and validation of biomarkers for prostate cancer.

The need for validated standards to make research results reproducible and comparable was a major factor in NCI's selection of ATCC to design the biospecimen coordination system. ATCC is the global leader in the definition and establishment of standard biological materials necessary for consistent experimental methodology and the valid comparison of research data.

"ATCC is delighted to take this role in the biospecimen network project and to team with NCI in delivering clinical biospecimen management services to cancer researchers around the world," ATCC President and CEO Raymond Cypess, DVM/PhD, said.

The Biospecimen Coordination System, which ATCC is charged with designing and implementing, will support the multi-site enrollment of patient volunteers as well as the collection of their biospecimens and associated clinical information. Harmonized approaches for ethical oversight, informed consent will be used. Standard operating procedures for clinical data collection and biospecimen preservation, processing, storage and dissemination will be developed based on ATCC long history of expertise in this area.

"With ATCC's involvement in the National Biospecimen Network, NCI-funded investigators can take advantage of our organization's technical know-how and experience in biorepository management services," Cypess added.

A not-for-profit organization with 80 years of biorepository experience, ATCC continually works to improve the science and technology knowledge base that underlies authentication and preservation of biological materials through its state-of-the-art translational research and development programs.

Partnering with ATCC on the NCI contract will be global consulting firm BoozAllenHamilton and the Johns Hopkins University. BAH will be designing the bioinformatics infrastructure to enable the management of the data associated with the clinical specimens. JHU will provide pathology support.

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Quality Technologies LLC Joins ATCC Licensed Derivative® Program
November 1, 2005

ATCC® announced today the addition of California-based Quality Technologies LLC to its Licensed Derivative program, a relationship that will improve the quality of microbiology products and protect consumers impacted by them.

The license agreement between ATCC and Quality Technologies, a provider of commercial products to microbiology laboratories, represents a major expansion of ATCC's Licensed Derivative program and assures quality control professionals and consumers that products bearing ATCC's Licensed Derivative emblem contain microorganisms with confirmed identity, viability and purity.

ATCC is the world's largest biological resource center and the most comprehensive source of reference cultures and reagents used by researchers in academic, government and industrial laboratories. Frequently, unauthorized for-profit companies incorporate ATCC biomaterials into their own commercial products without complying with ATCC's material transfer agreement. Without an established relationship with ATCC, those firms sell products containing microorganisms that lack affirmation of authenticity from ATCC.

ATCC President and CEO Dr. Raymond Cypess, said "We are delighted that Quality Technologies has joined ATCC's Licensed Derivative program and showed their dedication to aiding scientists and protecting consumers by expanding the range of products for which the identity and purity of ATCC-derived microorganisms is assured."

As a public science company, ATCC takes very seriously our responsibility to ensure the safety and quality of the materials we provide," Cypess added. "Quality control professionals need to know with certainty that the materials at the foundation of their testing are authentic. By purchasing materials that carry the Licensed Derivative emblem, customers can trust that the characteristics of the ATCC-derived microorganisms have been maintained and verified until they reach the end users."

For over 10 years, Quality Technologies LLC has developed, manufactured and distributed commercial products for use in microbiological laboratories around the world. "We are proud to be a part of the ATCC Licensed Derivative program," said Quality Technologies LLC President Dr. James Greenwood. "In joining ATCC's effort and passing their rigorous evaluation of our quality control and culture validation process, we further increase assurance for our customers that our family of microorganisms is derived directly from ATCC and maintains its characteristics in products used in the industrial, clinical or environmental setting."

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Nucleofector® Technology now Combined with the World's Largest Cell Line Collection
September 22, 2005

amaxa GmbH and the American Type Culture Collection (ATCC®) have entered into an agreement whereby ATCC will supply amaxa with cell lines to develop and optimize protocols using amaxa's Nucleofector® technology. This partnership will help researchers save valuable time by allowing them to work immediately with optimized and ready-to-use non-viral transfection protocols on a wide range of cell lines.

"It is our goal to enable our customers to genetically manipulate the cell types they consider the best experimental model. In looking for a partner, we needed a large collection of cell lines that came with reliable authentication. ATCC was the obvious choice," said Rainer Christine, CEO, amaxa. "Our combined efforts will bring the life science community a big step closer to this goal."

"Scientists purchase cell lines from ATCC for a variety of experimental tasks including transfection. By cross-referencing optimized protocols developed by amaxa with detailed information about ATCC cell lines, we are making it easier for researchers to be successful with genuine ATCC cultures and amaxa Nucleofector® technology," said Mike Gove, Vice President, Sales and Marketing, ATCC.

The partnership will be supported by easy access to comprehensive technical information provided on the companies' websites and by technical service specialists.

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ATCC and Competitive Technologies, Inc. Partner to Provide Novel Escrow Services for Licensed Biological Materials
August 23, 2005

ATCC and Competitive Technologies, Inc. (AMEX: CTT) announced today the launch of a new escrow service for biological materials that are the subject of license agreements. This relationship will combine ATCC's expertise in managing the storage and distribution of biological materials with CTT's technology commercialization expertise.

The escrow service is designed to assist technology companies and universities in protecting valuable biological materials, as well as associated information. The escrow service will assure organizations engaged in licensing activities that their biological materials will remain secure and available to the parties as necessary during the term of a license agreement.

Protecting the security of biological materials and associated data is critical to ensuring continued advances in research and development and applying new technologies in biomedicine and industry.

"ATCC is delighted to partner with CTT in providing this important service. License agreements involving biological materials require a mechanism for assuring the security and continued availability of these materials during the effective term of the agreement," said Dr. Jesús Soriano, ATCC's VP of Licensing, Contracts and Compliance. "CTT's expertise in commercializing intellectual property assures that the escrow service fully supports all elements of a licensing agreement. The new escrow service offers established and start-up technology companies a complete technology management service for biological materials."

"ATCC's extensive experience in cryopreservation and storage of biological materials provides the necessary assurance that deposits of these materials for escrow purposes are maintained under the highest standards of security, safety and confidentiality," according to Aris Despo, CTT's Senior VP for Life Sciences. "We are excited to bring this new escrow service to CTT's expanding relationships with industry and universities. Our alliance with ATCC is part of our technology commercialization strategy to deliver value-added services to generate recurring revenue and increase shareholder value."

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ATCC Launches the ATCC Genuine Cultures™ Emblem
June 6, 2005

ATCC today unveiled its ATCC Genuine Cultures™ emblem at the American Society for Microbiology's 105th General Meeting in Atlanta.

The ATCC Genuine Cultures emblem was designed to help customers identify authentic ATCC microbial strains that come directly from ATCC. The authenticity of microorganisms is paramount to the scientific process because these microorganisms serve as the foundation for scientific discovery.

Biological resource centers collect, authenticate, preserve and distribute biological materials for life science research. These knowledge centers advance science by providing access to and equitable distribution of biological materials such as cell lines, microorganisms and reagents.

ATCC catalog numbers are trademarks of the ATCC that have become universally recognized throughout the bioscience community to identify organisms. "Unfortunately, the frequent use of ATCC designations can make it difficult for the customer to tell which products are authentic ATCC strains and which are counterfeits," explained Raymond H. Cypess, D.V.M., Ph.D., ATCC President and CEO. "The ATCC Genuine Cultures emblem assures customers that the product is a genuine ATCC culture and meets ATCC's high standards backed by meticulous laboratory procedures and 80 years of experience."

The ATCC Genuine Cultures emblem signifies the highest quality for microbial strains, including:

  • Full characterization of each strain to establish identity
  • Use of a seed stock system to minimize subculturing
  • Careful preservation and storage protocols to maintain the culture safely and effectively.

Today's unveiling of the ATCC Genuine Cultures emblem follows last week's introduction of the ATCC Licensed Derivative® program. While the ATCC Genuine Cultures emblem distinguishes authentic ATCC microbial strains, the ATCC Licensed Derivative program employs licensing agreements to ensure the integrity of ATCC ingredients used in ATCC-derived quality control products. Both the ATCC Genuine Cultures emblem and the ATCC Licensed Derivative program are part of the broader ATCC Standard Initiative to ensure safety, quality and validity in support of the scientific method and protection of the public.

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ATCC Unveils Licensed Derivative® Program
June 2, 2005

ATCC unveiled its new ATCC Licensed Derivative® program and signed the first license agreement under the program with Minnesota-based MicroBioLogics, Inc. ATCC established the program to assure consumers that products carrying this emblem meet ATCC's world-renowned standards for quality and safety.

By joining the ATCC Licensed Derivative program, companies agree to maintain the integrity of the ATCC ingredient contained in their product and allow ATCC to verify the quality of that ATCC ingredient before it reaches end-users. In return, the ATCC Licensed Derivative emblem assures customers of the authenticity and quality of the ATCC ingredient contained in that product.

"Our industry is being reformed by global awareness; materials must be appropriately developed, handled, stored, used, shipped and disposed of in order to try to preserve the highest possible standards for health, safety and the environment," explained Robert C. Coborn, President and CEO of MicroBioLogics, Inc., a supplier of quality control microorganisms to clinical, pharmaceutical, cosmetic, food quality and environmental laboratories. "This license agreement offers MicroBioLogics and its distribution network verification of the ATCC materials used in MicroBioLogics products."

According to Raymond H. Cypess, D.V.M., Ph.D., ATCC President and CEO, the ATCC Licensed Derivative program was created to protect the public, as well as private industry, government and academic organizations around the world that use ATCC-derived materials in their products and services.

"As a public science company, we take very seriously our responsibility in ensuring the safety and quality of the materials provided by ATCC," Dr. Cypess explained. "Industrial scientists need to know with certainty that the materials at the foundation of their discoveries are authentic. By purchasing materials that carry the new ATCC Licensed Derivative emblem, customers can trust that the characteristics of the ATCC-derived products have been maintained and verified until they reach the end-users."

"We are very pleased that MicroBioLogics has become the first supplier to enter into a license agreement with ATCC," said Dr. Cypess. "This decision demonstrates MicroBioLogics' commitment to quality control microbiology."

"We are proud that MicroBioLogics is the first supplier to adopt the ATCC Licensed Derivative program," Coborn said. "It is an honor to have achieved the many levels of assurance and compliance required to gain the approval of ATCC as a licensed product manufacturer."

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ATCC and Ardais to Deliver Scalable Biospecimen Management
February 25, 2005

ATCC and Ardais Corporation have announced a strategic partnership to offer scalable biospecimen management services, addressing the escalating challenges faced by biotechnology, pharmaceutical, and academic institutions in managing biospecimens for drug development.

This partnership will combine ATCC's expertise in biological materials handling with Ardais' expertise in logistics, information technology, and clinical data solutions. "Translational medicine requires large-scale collection, management, and storage of clinically annotated biospecimens," said Donald B. Hawthorne, President and CEO of Ardais Corporation. "With its 80 years of biological materials handling expertise, ATCC has industrialized biospecimen storage, processing, and distribution. As adoption of the Ardais System accelerates, there will be a greater need for solutions of the scope offered by ATCC."

Biospecimen management is vital for generating and correlating the clinical and molecular data necessary to develop targeted diagnostics, therapeutics, and preventatives. The Ardais System addresses the need for large-scale, systematized, and standardized collection of biospecimens and associated donor- and sample-level clinical and molecular data. The System provides end-to-end support—from donor enrollment and informed consent through sample collection, processing and storage—as well as collection of associated clinical data. It also provides real-time tracking of the chain-of-custody for every biospecimen.

"As the world's leading biological resource center, ATCC offers the scientific community a broad range of products and services for the advancement, validation, and application of scientific knowledge," said Frank Simione, Vice President of Management and Compliance Services at ATCC. "Our partnership with Ardais will add value to our offerings in the form of a sophisticated logistics, information technology, and clinical data solutions for biospecimen management."

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ATCC to Develop and Distribute Products from Geron Corp.
May 24, 2004

Geron Corporation has granted to ATCC a nonexclusive license to create and distribute cell lines immortalized with human telomerase reverse transcriptase (hTERT) and the hTERT gene itself to the research-use-only market.

Geron has also designated ATCC as ex-situ repository and distributor of Geron-created immortalized cell lines and hTERT plasmids to non-profit institutions worldwide. The license to ATCC excludes therapeutic or diagnostic use of hTERT, use in human clinical research, and certain other uses that would compete or conflict with Geron's product development programs.

Telomerase is an enzyme that maintains telomere length and allows cells to divide indefinitely while retaining normal function and phenotype. Telomerase-immortalized human cells provide stable, uniform cell populations for functional cell-based assays and long-term gene expression studies. These cell lines can undergo repeated rounds of genetic engineering and scale-up.

"Telomerase is a very important tool in biopharmaceutical research," said Calvin B. Harley, Ph.D., Geron's chief scientific officer. "There has been a consistent demand among researchers for hTERT-immortalized cell lines, which can proliferate indefinitely while maintaining normal physical and biological characteristics. Many repeated or long-term studies cannot readily be done with mortal cells or with cells transformed in ways that change their morphology or function, but can be done with hTERT-immortalized cells."

"Because Geron is focused on its therapeutic and diagnostic product development programs, we have not been able to meet this demand the way ATCC can," added David L. Greenwood, Geron's executive vice president and chief financial officer. "As the leading global bioresource center, ATCC is an ideal partner for the standardization and distribution of hTERT plasmids and immortalized cell lines."

Dr. Raymond H. Cypess, president and CEO of ATCC, said "ATCC continues to play an essential role in the technology transfer process. This partnership is a mechanism by which ATCC will make available important research tools and models to the scientific community, while protecting intellectual property rights and promoting commercialization. In addition, ATCC will use the hTERT technology to develop new reference tools and models in support of scientific discovery and development processes across a wide variety of disciplines."

Geron is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic products for cancer based on its telomerase technology, and cell-based therapeutics using its human embryonic stem cell technology.

Learn more about hTERT products from ATCC.

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ATCC Hosts Aquatic Animal Conference
October 31, 2003

ATCC and the University of Miami hosted an international conference titled "Aquatic Animal Models of Human Disease" at the ATCC facility on September 29 through October 2, 2003. Sponsored primarily by the National Center for Research Resources of NIH, the conference drew 100 participants from government, academic, and private laboratories to examine a wide range of research tools through convened sessions, workshops, and posters.

Sessions offered discussions on a variety of topics, including using aquatic animals to investigate genomics, cancer, toxicology, infectious diseases, and neurological disorders. Workshops and posters were also featured at the conference.

Both the scientific content and the venue for the conference were praised by the attendees, who appreciated the opportunity to network with researchers in similar fields. Because of the proximity of the meeting location to Washington, D.C., several different government agencies were represented. Many participants expressed the hope that the conference would be held every two years.

Dr. Carrie O'Farrell, Director of Collections at ATCC and co-organizer of the conference, was pleased with the participation. "Because there is no one scientific society to bring these researchers together, this was an excellent opportunity for scientists to meet and share their exciting work with colleagues who use similar systems to investigate a variety of human disorders," she said.

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The Johns Hopkins University and ATCC Form Collaboration
September 11, 2003

In an unusual collaboration, The Johns Hopkins University and ATCC have established the Johns Hopkins Special Collection, an ever-expanding set of biological materials developed at Johns Hopkins that will now be more readily available to researchers worldwide through ATCC.

The research materials offered through the special collection include cell lines (such as rat prostate cancer and lung cells from a person with cystic fibrosis), clones of important human genes, and "kits" that simplify creation of viruses carrying genetic instructions.

"This collaboration disseminates, publicizes and safeguards our faculty's research materials through a highly regulated channel," says William Tew, Ph.D., associate provost and assistant dean of Licensing and Technology Development at Johns Hopkins. "Our scientists can more easily share important research materials, and ATCC strengthens their product listings. Scientists worldwide stand to benefit from these efforts."

Once a new potential product, such as a cell line or key bit of DNA, is described in a peer-reviewed scientific literature and a few outside scientists have requested the item, it will be eligible for inclusion in the special collection. ATCC, a leading source of biologic research materials since 1925, provides secure maintenance of the materials, promotes their availability, protects intellectual property rights and documents compliance with regulations regarding the shipping of materials.

"Our expertise in all aspects of materials management provides global access to materials developed by Johns Hopkins researchers," says Raymond Cypess, D.V.M., Ph.D., President and CEO of ATCC. "The Johns Hopkins Special Collection offers scientists access to important biological reagents efficiently, promptly and safely."

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FDA Taps ATCC in Fight Against Antibiotic Resistance
February 14, 2003

ATCC has been awarded a three-year, $600,000 contract by the federal Food and Drug Administration (FDA) to study the mechanism and speed at which microbes develop resistance to veterinary antibiotics after they are introduced and become widely used on the farm.

Many scientists believe that overuse of antibiotics in livestock contributes to the growing problem of antibiotic-resistant bacteria in humans. The Centers for Disease Control and Prevention (CDC) calls antimicrobial resistance one of its top concerns. Infections caused by resistant microbes are becoming more serious and difficult to treat, and the cost in the United States may be as high as $4.5 billion per year.

ATCC will acquire and characterize resistant strains, study the mechanism and degree of resistance, and make cultures available to medical researchers around the world to aid in their study.

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New Facility Opens, Enhances ATCC Service to Customers
February 14, 2003

With the dedication early last December of a new 19,000-square-foot addition to its existing 100,000-square-foot headquarters building, ATCC has significantly increased its distribution capacity to meet rising global demand for ATCC materials, especially genomic and cell biology products.

"This state-of-the-art facility permits us to serve our customers more quickly and efficiently than ever, and gives us additional repository storage for our general collections," said ATCC president and CEO Raymond H. Cypess. ATCC's general collections of biological materials contain more than 153,000 individual strains and some six million DNA clones.

Begun in April 2002, the addition was designed by the Smith Group architects of Washington, DC, and built at a cost of $4 million by Hitt Contracting, Fairfax, Virginia. It adjoins the original facility which was completed in 1998.

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ATCC Offers Protection for Valuable Proprietary Materials
February 14, 2003

ATCC has added cGMP-compliant safe deposit to its spectrum of laboratory services. This state-of-the-art, comprehensive service is offered to corporations, government laboratories and academic institutions to protect cell cultures and other valuable proprietary biological materials.

All materials are stored in large-capacity dedicated and validated liquid nitrogen freezers equipped with monitoring systems and 24-hour electronic and human surveillance, seven days a week. The facility alarm system is also monitored by an off-site central service, and staff equipped with pagers and cell phones are on call for immediate response to any alarm conditions. Back-up freezers are available if stored materials need to be temporarily relocated.

To assure confidentiality as well as safety, all rights to the cultures deposited with ATCC remain with the depositor, and all information regarding the material is retained in confidence. Culture material is available only to depositors or their designees, who must have written authorization to gain access to the material.

Only ATCC employees trained in current Good Manufacturing Practices (cGMP) have access to these deposited materials. In addition, all freezer entry and retrieval activities are supervised and verified by ATCC Quality Assurance personnel and third-party audits are provided annually to all depositors. In addition to cGMP compliance, repository staff are trained in the correct handing of material stored at cryogenic temperatures (-145°C or lower) and in good inventory practices.

ATCC also offers standard safe deposit and patent deposit services in addition to the general scientific collection.