Susan Dana Jones (sjones
bptc
com) and Howard Levine (hlevinebptccom) will be featured speakers at the Pall Forum for Advanced Bioprocessing to be held on April 19, 2011 in Charlottetown, PEI, Canada. Dr. Jones will speak on the “Use of QbD in Upstream Process Development” and Dr. Levine will speak “Manufacturing Facilities of the Future.” For more information about the forum or to register, click here.
By Susan Jones (sjonesbptccom) and Howard Levine (hlevinebptccom)
How many times have we heard companies say that they didn’t want to risk delays in their development programs by spending time to develop robust, high expressing production cell lines? Thinking that moving rapidly into GMP manufacturing using a cell bank derived from an unoptimized initial research cell line with low productivity and limited traceability constitutes “accelerating development,” these companies march forward with sub-optimal cell lines thinking that they are saving time. But what is the real impact of such an approach on the timelines for early stage product development? Consider the case of such a cell line expressing a monoclonal antibody at 100 mg/L.
