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Business & Regulation Quality & Compliance, Analytical Science

Animal-Free; Risk-Free

The risk of contamination is ever-present. Any given product, at any time – even when manufactured under cGMP and a robust Quality Management System can fall foul to the effects of contamination. The most at-risk products are those derived from biological sources, such as biopharmaceuticals, human cells, tissues, and cellular and tissue-based products (HCT/Ps). Therefore, donor tissues and cells can pose significant problems. “Title 21” of the FDA’s Code of Federal Regulations (21 CFR Part 1271) contains requirements for screening donations of human cells and tissues for relevant communicable disease agents or diseases, such as human immunodeficiency virus, hepatitis B virus, hepatitis C virus, and human transmissible spongiform encephalopathy.

The screening of donor tissues and cells is a critical step in the lifecycle of HCT/Ps. Transplantation and processing of donor tissues and cells cannot occur if a donor is shown to have risk factors for, and clinical evidence of, infection due to relevant communicable disease agents and diseases after thorough screening.

And after such rigorous testing, why then would you risk the reintroduction of one of these communicable diseases into your tissues and cells?  Though this question may sound absurd, the risk is real, especially for Creutzfeldt-Jakob disease (CJD).

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About the Author

Aaron Schieving

Vice President, Sales and Marketing at Lifecycle Biotechnologies, USA.

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