Biosafety of Biological Drug Products
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Who Should Attend
This course will be valuable to a broad range of professionals
in the biotechnology industry including:
• Scientific
• Managerial
• Regulatory
Scientific personnel will gain more familiarity with the
regulatory rationale for testing requirements. Regulatory and
managerial personnel will have an opportunity to learn more
about the technical aspects of various assays.
Description
This course will introduce the unique perspectives and
considerations of safety testing of biological drug products in
contrast to typical safety testing of chemically-derived
pharmaceuticals. Regulatory recommendations and
requirements at each level of development will be outlined
and accepted methods will be discussed in detail.
The course will also use the history of the last 25 years of
safety assessment of biologically derived therapeutics and a
case study approach to identifying current approach
strengths, weaknesses and successful pathways.