WP6:cGMP Production

The goal of this work strand will be cGMP production of two monoclonal antibodies (anti-SRBI and anti-E2) to be used in Phase I Clinical Trials against hepatitis C virus reinfection of liver transplants. The specific aims are to:

  • Produce two cGMP Master Cell Bank (MCB), one for each cell lines expressing the target monoclonal antibodies and perform the associated Quality and In-Process Control analysis

  • Transfer the anti-SRBI and anti-E2 monoclonal antibody production processes from P2 and P4 to P3 facilities by performing one engineering run for each target monoclonal antibody

  • Manufacture one clinical lot for each target monoclonal antibody and perform the associated Quality and In-Process Control analysis according to the cGMP requirements

Claudin