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Advances in Cell Culture Process Development: Tools and Techniques for Improving Cell Line Development and Process Optimization
Author(s) -
Sharfstein Susan T.
Publication year - 2008
Publication title -
biotechnology progress
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.572
H-Index - 129
eISSN - 1520-6033
pISSN - 8756-7938
DOI - 10.1021/bp070471q
Subject(s) - process (computing) , quality by design , quality (philosophy) , computer science , product (mathematics) , process management , process analytical technology , cell culture , critical quality attributes , process development , new product development , microbiology and biotechnology , biochemical engineering , work in process , engineering , business , biology , operations management , philosophy , geometry , genetics , mathematics , epistemology , marketing , operating system
Abstract At the 234th National Meeting of the American Chemical Society, held in Boston, MA, August 19–23, 2007, the ACS BIOT division held two oral sessions on Cell Culture Process Development. In addition, a number of posters were presented in this area. The critical issues facing cell culture process development today are how to effectively respond to the increase in product demands and decreased process timelines while maintaining robust process performance and product quality and responding to the Quality by Design initiative promulgated by the Food and Drug Administration. Two main areas were addressed in the presentations: first, to understand the effects of process conditions on productivity and product quality, and second, to achieve improved production cell lines. A variety of techniques to achieve these goals were presented, including automated flow cytometric analysis, a high‐throughput cell analysis and selection method, transcriptional and epigenetic techniques for analysis of cell lines and cell culture systems, and novel techniques for glycoform analysis.