Dr. Nanda Subbarao has been a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems since 2007. Prior to that, she was with Sandoz and Pfizer.
Biologics are different from chemical drugs because of: (1) they derive from living source materials, (2) biologic manufacturing processes are generally more complex, (3) biologic molecules themselves are much more complex and are often not easily characterized (4) biological molecules cannot be purified by simple recrystallization and (5) biological drug products cannot be terminally sterilized in the final container. While chemical drugs can become generics, biologics products are almost impossible to copy precisely and are therefore considered as “biosimilars”, and not as “bio-generics”.
Understand the critical importance and underlying principles for the QA/QC of biologics and biopharmaceuticals, and know how these principles differ from those for chemical-origin drug products
Be able to develop a clinical-phase appropriate, cost-effective strategy to effectively manage the quality lifecycle through clinical development into commercialization of diverse biologic/biopharmaceutical manufacturing processes and products, including establishing effective inter-company quality agreements with outsourced contractors
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