Standards and Controls

 

There is a recognized need for fully characterized, globally accepted reference materials and standards for establishing comparability and accuracy of results across time and among laboratories around the world. As a recognized standards development organization, ATCC is committed to providing the trustworthy reference materials and standards needed to support reproducibility in the life sciences.

We offer an extensive breadth and depth of content ranging from fully authenticated, characterized reference materials to national consensus standards for biomaterials and related processes. Many our products are recognized globally by government and commercial organizations as reference materials and they are specified as test organisms in several USP chapters and in test methods, guidances, and manuals prepared by the FDA, EPA, and USDA. Explore our resources below to see how we can support your testing and assay development needs.

 

Pharmaceutical Testing   Mycoplasma Testing   Water testing   Reference Materials   Standards

 

The United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP) have developed quality standards to support the production of safe pharmaceutical products. These standards specify the use of highly authenticated microbial strains from ATCC as challenge organisms to ensure that pharmaceutical products are free from objectionable microorganisms. As an ISO 9001–certified and ISO/IEC 17025–accredited organization, ATCC ensures that each of our quality control strains are carefully authenticated, managed, and preserved using protocols that maintain the genotype and phenotype.

Mycoplasma contamination is a serious concern for biopharmaceutical and gene therapy developers as it can pose significant safety risks for patients. Rigorously quality testing throughout the manufacturing process is essential for ensuring final products are free of mycoplasma contamination prior to use. To support your testing needs, ATCC provides titered mycoplasma strains and quantitative certified reference materials to help you build your own assay. We also provide a mycoplasma testing service and a detection kit.

Water is essential for human survival—from bodily functions to the manufacture of food and medicine. That’s why ensuring water quality through routine safety testing is paramount. Water testing can help pinpoint sources of biological contamination, identify contaminated water before it is used, and determine if a sterilization/purification program is working properly. Support your essential water testing programs with quality control strains from ATCC.

The validity of any assay is dependent upon authenticated, fully characterized reference materials. That’s why ATCC cultures are meticulously characterized and preserved to maintain these materials in a manner that permits reproducibility of results. We balance traditional biochemical testing methods with automated phenotypic and genotypic analyses. This provides highly accurate identification across a wide array of products. 

ATCC develops national consensus standards for biomaterials and related processes. In 2007, ATCC became the first biological resource organization to become accredited by American National Standards Institute (ANSI) as a Standards Development Organization (SDO). ANSI accreditation ensures that procedures used by standards developers meet the requirements for openness, balance, consensus, and due process and that the voluntary consensus standards produced are compatible with the requirements of the International Organization for Standardization (ISO). The following ATCC standards are available from ANSI.