Qualification and Validation of Analytical Methods for Protein Products
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Who Should Attend
This course contains material critical for those personnel in a
biotechnology company involved in the manufacture and
release of biopharmaceutical product at all points in
development including:
- Research and Development
- Quality Assurance
- Technology Transfer
- Quality Control
- Clinical and Product Development
- Manufacturing
Description
This course provides details of the development of assays and
the validation of assays for biopharmaceuticals. Both physical
and biological assays will be discussed. Emphasis will be
placed on the increasing importance of mass spectrometry in
the characterization of biological products. Issues of
bioequivalence will be discussed as an issue critical to the
development of biologic generics (follow-on biologicals).
Consideration is given to the issue of validation
implementation as part of the overall business strategy in the
development of a biological.