Ensuring the Biological Integrity of Raw Materials
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.
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Pharmaceutical Technology’s 2017 Biologics and Sterile Drug Manufacturing eBook.
Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact
April 16th 2025On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.
