Ensuring the Biological Integrity of Raw Materials

May 15, 2017
Catherine Shaffer

Catherine Shaffer is a contributing writer to BioPharm International, cathshaffer@gmail.com.

Pharmaceutical Technology, Pharmaceutical Technology-05-15-2017, Volume 2017 eBook, Issue 1
Pages: s31-s34

A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.

Contamination with microbes, mycoplasma, viruses, and adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can occur from many sources, raw materials are the most significant source of contamination. 

Strategies for preventing contamination including upfront testing of materials, barrier disinfection methods, and adhering to best practices in processing and sanitation are explored.

Avoidance of animal-based raw materials, as well as careful sourcing of any materials used, are discussed.