Biologics: Scale-Up, Tech Transfer and Validation

Ever wondered how the technical experiments in the laboratory, pilot plant studies and GMP batches fit together to deliver a process suitable for an IND/IMPD and ultimately BLA/MAA Join this course to understand how the various technical disciplines fit together with Regulatory and QA to deliver a process that is capable of consistently delivering molecules of the right quality. Hear case studies of why tech transfer is important, what can go wrong and the commercial and timeline impact it can have. Understand how CQAs (critical quality attributes) are identified and how they relate to CPPs (Critical process parameters) and how increasing understanding of the product manufacturing process builds towards being ready for process validation

Who should attend?

Process development scientists, upstream & downstream scientists, MSAT scientists, QA/QC researchers, lab technicians, and students looking to enhance knowledge of GMP Guidelines or to be ready for the next career step.

A Certificate of Attendance will be issued upon completion of the course.