Ensuring the Biological Integrity of Raw Materials

Publication
Article
Pharmaceutical TechnologyPharmaceutical 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.

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Articles in this issue
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Clean, Disinfect, and Validate
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Kill the Bioburden, Not the Biological Indicator
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Cold Chain Logistics for Personalized Medicine: Dealing With Complexity
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Ensuring the Biological Integrity of Raw Materials
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Getting Biopharmaceutical Tech Transfer Right the First Time
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Developing an Injectable Compound for a Dual- Chamber Delivery System
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Case Study: Retrofitting Two New High-Purity Water Systems
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Single-Use Bioreactors Have Reached the Big Time
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Parallel Processing
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Cost Considerations Drive Lean Technology in Biomanufacturing
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