Assay Development and Validation for Biopharmaceuticals
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This course is available as a client site course. Please click here for more information.
Who Should Attend
This course contains material critical for those functions in
a biotechnology company involved in the manufacture and
release of biopharmaceutical product. It is of benefit to
individuals in companies at all points in development from
early-stage to established fully-integrated pharmaceutical
companies (FIPCO’s). Specific groups that will benefit
include research and development, technology transfer,
manufacturing, quality control, quality assurance, clinical
and product development.
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.
Attend this course and its companion course, cGMP and Quality Issues for Biopharmaceuticals, ID #1932 (Session #05D1932-271) and save $400 off the combined tuition.