In the search for new solutions to advance global health and strengthen our nation's biodefense, you need a partner who has the track record and the expertise to tackle intractable problems. Preparing for, responding to, and recovering from complex infectious diseases, whether naturally occurring or intentionally introduced, requires scientific expertise and support from a trusted partner like ATCC. We provide government agencies with diagnostic reagents and surveillance kits, subject matter expertise, and research and development (R&D) services to support infectious and chronic disease agent characterization and medical countermeasure development.
Infectious diseases and pandemic response
Recent experience shows the devastating effects that result from an unchecked biothreat. Your preparedness requires a reliable partner to focus on the mission with integrity, expertise and the utmost security. We support pandemic responses and other global health priorities with agility and expertise to help save lives and ensure the protection of people worldwide. We are an essential collaborator for the federal government’s pandemic preparedness and response to global health emergencies, supporting responses to the SARS-CoV-2 pandemic, the 2009 swine influenza pandemic (H1N1pdm09), the 2011 influenza outbreak (H3N2), the 2013 avian influenza outbreak (H7N9), and the 2015 Zika virus outbreak.
SARS-CoV-2 Response Support
We are supporting the government's SARS-CoV-2 response by providing laboratory services, logistical operations, and expertise. Our Subject Matter Experts (SMEs) are advising the government on viral propagation and genomic analysis, optimizing supply chains, and communicating end user requirements, including:
- Production and global distribution of customized reagents, such as heat-inactivated virus, challenge stocks, and antibodies
- Participation in working groups and subject matter expertise on topics such as large-scale virus preparations and genomic analysis
- Receipt, storage, inventory, and distribution of clinical study samples and investigational products
Diagnostic and surveillance kits
ATCC has more than 10 years' experience collaborating with government SMEs to gather requirements for viral and bacterial diagnostic and surveillance kits for development, production, and distribution, and related reagents panels. Subsequently, we tailor standard operating procedures and perform testing to ensure government quality and acceptance requirements are met for solutions that include:
- In Vitro Diagnostic (IVD) Real-time RT-PCR Kits
- Research Use Only (RUO) Real-time RT-PCR Kits
- Multi-Segment Reverse Transcription (MRT) PCR Kits
- Viral and Bacterial Reagent Panels and Reference Stains
- Yellow Fever Surveillance Kits
ATCC provides labeled vials, printed package inserts and packaging materials and associated labels. After assembly, we store and distribute kits to stakeholders worldwide.
Subject Matter Expertise
Our scientists provide expertise to solve your most challenging problems. We support the federal government with advice and expertise in global health, biodefense, clinical studies, and biological resource management to ensure programs meet their goals and missions are achieved.
We help achieve your objectives through:
- Assessing mission needs
- Developing technical requirements and R&D strategies
- Performing analysis of alternatives
- Surveying published research
- Producing white papers
- Convening and leading working groups
- Conducting procurement activities
- Executing programs
Our expertise, facilities, and quality biological materials allow us to support R&D for medical countermeasures including development of diagnostic assays, vaccines, and therapeutics. ATCC has supported infectious disease research and the pharmaceutical industry with the following reagent types and services:
- ATCC’s unparalleled collection of microbial pathogen strains, including CLSI, FDA and USP-cited standards for health industries
- Bacterial, viral and protist reference strains and derivatives widely used in development of diagnostic assays using protein or nucleic acid detection
- Human and mammalian cell lines and models for injury-induced and infectious disease research
- Inactivated pathogens for biological research and use as controls in detection and diagnostic assays
- Synthetic biological standards based on pathogen nucleic acid sequence
- Antibody production for bacterial and viral pathogens, including production, validation, sequencing and neutralization testing of monoclonal antibodies
- Purified nucleic acids and proteins from pathogens
- Recombinant and chimeric proteins and expression vectors
- Expertise in providing in vitro assay capabilities for Minimum Inhibitory Concentration (MIC) screening of potential antimicrobial therapeutics
- Whole genome and next generation sequence analysis for strain identification, differentiation and detection of SNPs and mutations, transcriptomics and population bioinformatics
- CRISPR technology for genetic modification
ATCC offers full lifecycle support to epidemiological and other clinical studies, from planning sample collection to final disposition. For more than 30 years we have supported clinical studies ranging from investigation of cancer and associated genetics to health and nutrition. We have processed, stored and distributed millions of government clinical research materials including:
- Human biospecimens and their derivatives
- Cell lines and models for inherited and injury-induced disease
- Viruses and other intracellular and bloodborne pathogens
- Biological reagents and derivatives (eg, cell lysates, serum samples, nucleic acids, and proteins)
- Drug compounds, chemicals, investigational drug products, and antivirals
We support cutting-edge cancer research by developing a wide variety of next-generation 2D and 3D patient-derived in vitro cancer models, including organoids and conditionally reprogrammed cells. These authenticated models are derived from primary, metastatic, and recurring tumors and are characterized in terms of clinical and sequence data.
We provide clinical sites with supplies, equipment, and manuals for collecting, processing, and aliquoting biospecimens. We coordinate with clinical sites, study coordinating centers, couriers, testing laboratories, and other repositories to ensure sample integrity during shipment and document full life cycle data management. We process clinical research biological samples on-site, many on the day of receipt, to include blood fractionation, nucleic acid extraction and quantitation, aliquoting, and cryopreservation. In addition, we provide weighing, dispensing, aliquoting, and labeling of pharmaceutical products. For more details visit, Clinical Study Support.
Our state-of-the-art facilities and equipment are designed to support emerging global health and biodefense research. Since 1996, ATCC has been authorized by the Centers for Disease Control and Prevention (CDC) and United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) to possess, use, and transfer select agents and toxins. Our existing facilities feature Biosafety Level (BSL)-1, BSL-2, BSL-2 enhanced (BSL-2+), BSL-3, and BSL-3 enhanced (BSL-3+) production and authentication laboratories for bacteriology, virology, parasitology, mycology, protein, nucleic acid, and immunological reagents. For projects requiring BSL-4 facilities, ATCC works with several qualified partners. The CDC/USDA has inspected all applicable laboratories where we are registered for work with highly pathogenic biospecimens under the United States Federal Select Agent Program. In addition, we offer an Animal Biosafety Level (ABSL)-2 Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) accredited small animal models vivarium.
Samples stored in ATCC’s repositories are under constant temperature monitoring (i.e., room temperature, +4°C, -20°C, -80°C and liquid nitrogen (LN2) and our facilities are equipped with alarm systems that monitor facility-wide adverse conditions such as fires, unauthorized access, and equipment malfunctions.
Shipping logistics and compliance
ATCC follows formal protocols for sample receipt and inspection. We coordinate with depositors and submitters to ensure proper packaging and cold chain is maintained. Our Customer Care team provides support for execution of User Agreements and Material Transfer Agreements (MTAs) to protect intellectual property rights. Distribution to recipients worldwide, such as Public Health Laboratories and testing laboratories, are coordinated to ensure that shipments arrive in a timely manner under proper cold chain. This includes compliance with all Department of Transportation (DOT) regulations (49 CFR 100-185) and International Air Transport Association /International Civil Aviation Organization (IATA/ ICAO) regulations for shipping containers, documentation, and processes. ATCC’s Regulatory and Compliance department ensures all laws and regulations are followed, including obtaining licenses and permits such as:
- 9 CFR 122: Import or domestic transfer of livestock pathogens or biological materials that may contain animal origin material
- 42 CFR 71.54: Import of infectious biological agents, infectious substances or vectors of human disease
- 15 CFR 730-774: Export of agents listed on the Commerce Control List (CCL)
- 50 CFR 10, 13, 17 and 23: Import, export, trade and sale of products covered by Federal Fish and Wildlife laws
- §4-71A: Import of restricted microorganisms
- 7 CFR 330: Import or domestic transfer of plants and plant products
- 42 CFR 73, 9 CFR 121, and 7 CFR 331: Import or domestic transfer of select agents
Quality management and best practices
Our facilities comply with our International Standards Organization (ISO) 9001 accredited Quality Management System (QMS), which provides oversight of materials, data and procedures in order to assure reliability of results and sample safety. Additionally, we maintain:
- ISO 13485 - Design, development, production, testing, and distribution of medical devices
- ISO 17034 - General Requirements for the competence of reference material producers
- ISO/IEC 17025 - Accreditation for testing
As a founding member of the International Society for Biological and Environmental Repositories (ISBER), we follow all best practices and guidelines for repository management. We operate in accordance with the Office of Science and Technology Policy (OSTP) requirement for good stewardship of scientific collections by federal agencies, Office of Management and Budget (OMB) clearance, Institutional Review Board (IRB), and confidentiality requirements.
Third-party conformance testing
ATCC performs authentication and quality control (QC) tests to assure identity and performance of government materials for biodefense and public health responses. Authentication tests verify the identity, purity and/or functionality of the material for its intended use. QC tests provide lot-specific measures and criteria to qualify both the initial and subsequent lots produced to ensure product consistency and equivalency to the authenticated source material. Authentication and quality control tests used for evaluation of products produced in-house and submitted as part of third-party testing includes:
- Genotypic tests
- Phenotypic tests
- Purity and contamination
- Functional activity
- Composition or concentration
Our modern inventory management systems assure accountability and traceability of your government materials. Our technical teams use multiple electronic inventory management platforms, including platforms shared with government agencies and their stakeholders, to document full life cycle sample tracking. Routine physical inventory activities confirm data accuracy. We also develop and manage dedicated website portals for government user communities that serve as a single point for registration, ordering, depositing, documents, and customer service.
ATCC has over 50 years of successful government contract management experience of global health and biodefense programs. Our PMP-certified project management team uses the processes, procedures, and standards defined by the Project Management Institute in the Project Management Body of Knowledge (PMBOK®) as the principal guidelines for the management of all internal and external activities. Our proactive approach to program management minimizes government risk and allows for efficient, flexible support to changing government priorities.
Global Health and Biodefense Contracts
USDA National Bio and Agro-Defense Facility (NBAF) Biorepository Transfer Support (as a subcontractor to Merrick and Co. Inc.)
ATCC is supporting the transfer of biological materials from the Plum Island Animal Disease Center in New York to the NBAF in Manhattan, Kansas.Learn more
Joint Program Executive Office (JPEO) CB Defense (JE-RDAP)
ATCC is a performer on this omnibus IDIQ contract vehicle to attain future research, development, acquisition, procurement, and fielding of CBRNE defense systems, equipment and materiel.Learn more
NIAID Preclinical Models of Infectious Diseases
ATCC is a performer on this IDIQ contract for the “Non-traditional Animal Models” focus area.Visit the website
Biodefense and Emerging Infections Resources
Biodefense and Emerging Infections (BEI) Resources was established by the National Institute of Allergy and Infectious Diseases (NIAID) to provide reagents, tools and information for studying Category A, B, and C priority pathogens, emerging infectious disease agents, non-pathogenic microbes and other microbiological materials of relevance to the research community.Get details
International Reagent Resource
The International Reagent Resource (IRR) was established by the Centers for Disease Control and Prevention (CDC) to provide registered users with reagents, test kits, and information for the study and detection of emerging bacterial and viral pathogens, as well as outbreak response.Get details
HIV Reagent Program
The NIH HIV Reagent Program was established in 1988 to provide critical research reagents and resources to the scientific community. The NIH HIV Reagent Program acquires, develops and produces state-of-the-art reagents and provides these reagents at no cost to qualified investigators throughout the world.Get details
Additional ATCC support for government programs
Biological Resource Support
ATCC operates and manages biological resource programs, including new product development, accessions, production, authentication, storage, and distribution.Learn about our expertise
Clinical Study Support
ATCC provides clinical and epidemiological study support to include provision of collection supplies, sample receipt and storage, biospecimen processing, and distribution.explore now
Contact ATCC Federal Solutions
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