Monoclonal Antibody Manufacturing: From Cell Banks to Drug Substance
@Biotech Training Facility
This training provides QA professionals with a practical understanding of monoclonal antibody (mAb) manufacturing, focusing on the key process steps, GMP requirements and quality considerations relevant to biological drug substance production.
Participants will follow the manufacturing process from master and working cell banks through cell expansion, inoculation, harvesting, upstream processing (USP) and downstream processing (DSP), up to the drug substance (DS) stage. The training covers the differences between USP and DSP, the importance of viral safety testing, and key GMP principles, including the use of clean and sterilised equipment, single-use versus reusable systems, and maintaining system integrity.
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Monoclonal Antibody Manufacturing: From cell banks to drug substance