Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
News|Articles|May 15, 2017
- Pharmaceutical Technology-05-15-2017
- Volume 2017 eBook
- Issue 1
Ensuring the Biological Integrity of Raw Materials
Author(s)Catherine Shaffer
A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.
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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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Kill the Bioburden, Not the Biological Indicatorover 9 years ago
Getting Biopharmaceutical Tech Transfer Right the First Timeover 9 years ago
Case Study: Retrofitting Two New High-Purity Water Systemsover 9 years ago
Single-Use Bioreactors Have Reached the Big Timeover 9 years ago
Parallel Processingover 9 years ago
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