A consortium of the companies shown above, collectively known as the CMC-Biotech Working Group (CMC-BWG), has prepared a case study on the development of a monoclonal antibody. To view the entire case study please click here. The case study is intended to stimulate discussion between regulatory authorities and industry on the application of Quality by Design to products of biotechnology. CASSS has joined forces with the individuals of the consortium to promote and disseminate the case study.
The case study is not a mock submission, nor a gold standard defining the content of future regulatory submissions, and is not intended to be reviewed for approvability. The case study presents some novel ideas, and aspirational approaches that could be achieved when the principles of QbD are fully embraced. This marks a significant opportunity to expand the discussion in the biotechnology community on the implementation of the advanced concepts of QbD.
In addition to highlighting the case study here on our web site, we have plans to use it extensively around the world in discussions with industry and regulators throughout 2010 and beyond. Look for sessions in the programs of the CMC Forum Europe (April 2010) and CMC Strategy Forum (July 2010) as well other workshops to be announced focusing on the A-Mab Case Study.
Biotech Working Group Team Members Only - Click Here