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: 17th - 19th October, 2012Location
: King of Prussia, PA, USASummary:
Pharmaceutical - Training
While there are considerable similarities between biologics/biopharmaceuticals and chemically-synthesized drug products, many of the QA/QC issues and challenges are significantly different. Biology-based drug products are more complex products, derived from potentially changing living sources that are highly susceptible to contamination with adventitious agents such as prions, viruses and mycoplasmas. Process-related impurities in biologic/biopharmaceutical products raise concern not only of potential toxicity but also of tumorigenicity and immunogenicity. Furthermore, unlike many chemically-synthesized drug products, the manufacturing process itself can impact both the potency and the immunogenicity of biologic/biopharmaceutical products.
This landscape for biologic and biopharmaceutical products, coupled with ongoing changes in regulations and expectations, makes it extremely important for a company to have an effective QA/QC risk management strategy for each stage of drug development, from Phase 1 clinical trials through market approval.
This course highlights the challenges and pressures facing QA/QC in today’s biologic and biopharmaceutical environment, and presents the strategic importance and value generated by QA/QC for their involvement in control of the manufacturing process, and testing and release of these products. QA/QC regulations and guidances from the U.S. FDA, EMEA and ICH are discussed in detail.
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