BIOT 278 |
| A case study is presented in which Process Development and Manufacturing groups at Biogen Idec worked closely to identify the root cause and provide a solution for a critical problem in a recent late stage antibody manufacturing campaign. In addition to Cell Culture Development's (CCD) primary role of developing and transferring cell culture processes to Manufacturing, CCD also continues to support Manufacturing throughout the campaigns to ensure success, predominantly by helping to troubleshoot issues that may arise. These activities involve working with Manufacturing to identify the source of a problem, performing laboratory studies to evaluate solutions to the problem, and offering recommendations as a path forward for the campaign. Recently, this type of support was demonstrated in a late state antibody manufacturing campaign in which the cells from the Working Cell Bank (WCB) vials failed to recover from thaw. Since the manufacture of the drug depends upon the successful growth and productivity of these cells, resolving this issue quickly was crucial to avoid campaign delays or cancellation. In order to determine the possible cause of thaw failure, Cell Culture Development launched an investigation to systematically identify the root of the problem, determined the best path forward for the campaign, and made provisions for future campaigns. |
|
Poster Session
5:30 PM-7:30 PM, Wednesday, August 22, 2007 BCEC -- Exhibit Hall - B2, Poster
Division of Biochemical Technology |