Biological products include a wide range of complex substances such as vaccines, gene therapies, monoclonal antibodies, and recombinant therapeutic proteins. In contrast to most drugs that are chemically synthesized, biologics are manufactured in living cells. The demand for viruses and therapeutic macromolecules produced from mammalian cell culture is increasing along with the number of biopharmaceuticals that are currently in preclinical stage of development. In this regard, ATCC provides a variety of products that support the development and sterility testing of biologics.

• Virus and protein production – We offer both commonly used bioproduction cell lines for virus and protein manufacturing as well as STAT1 knockout models for enhanced virus production.
• Gene therapy development – ATCC provides a STAT1 BAX double knockout model for the enhanced production of adeno-associated viruses. We also offer internationally accepted viral reference materials that enable the standardization of quantification techniques when developing viral-vector-based gene therapies.
• Sterility testing – Our portfolio includes a variety of mycoplasma products and a PCR-based mycoplasma detection service that enable you to test your biologics for this common cell culture contaminant. We also provide reference strains recommended by the United States Pharmacopeia for evaluating biologics for sterility.
• Residual host cell DNA testing – ATCC and USP have formed a collaboration to provide highly characterized and pure genomic DNA analytical reference materials for validating the performance of molecular assays designed to detect and measure residual host cell genomic DNA.