Abstract
The transfer of processes for biotherapeutic products into finalmanufacturing facilities was frequently problematic during the 1980's and early 1990's, resulting in costly delays to licensure(Pisano 1997). While plant startups for this class of products can become chaotic affairs, this is not an inherent or intrinsic feature. Major classes of process startup problems have been identified andmechanisms have been developed to reduce their likelihood of occurrence. These classes of process startup problems and resolution mechanisms are the major topic of this article. With proper planning and sufficient staffing, the probably of a smooth process startup for a biopharmaceutical product can be very high – i.e., successful process performance will often beachieved within the first two full-scale process lots in the plant. The primary focus of this article is the role of the Process Development Group in helping to assure this high probability of success.
Similar content being viewed by others
References
Andersen DC, Swartz J, Ryll T, Lin N & Snedecor B (2001) Metabolic oscillations in an E. Coli fermentation. Biotechnol Bioeng 75: 212–218.
Birch JR, Boraston R & Wood L (1985) Bulk production of monoclonal antibodies in fermenters. Trends Biotechnol 3: 162–166.
Gerson DF, Himes V, Hopfer R, Khandke L, Kohn F, Komotar A, Krumm P, Machulski J, Weisser A & Sciotto-Brown S (1998) Transfer of Processes from Development to Manufacturing. Drug Inform J 32: 19–26.
Goochee CF & Monica T (1990) Environmental effects on protein glycosylation, Bio/Technology 8: 421–427.
Hu, W-S & Aunins JG (1997) Large-scale mammalian cell culture. Currt Opin Biotechnol 8: 148–153.
Pisano GP (1997) The Development Factory. Harvard Business School Press, Boston.
Swartz JR (1994), U.S. Patent 5,342,763. Method for Producing Polypeptide via Bacterial Fermentation, Issued 8/30/94.
Swartz JR (1996), U.S. Patent 5,487,980. Method of Determining Propensity for Dissolved Oxygen Instability, Issued 1/30/96.
Swartz JR (1997), U.S. Patent 5,633,165. Fermentor with Vertical Shaft, Issued May 27, 1997.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Goochee, C.F. The roles of a process development group in biopharmaceutical process startup. Cytotechnology 38, 63–76 (2002). https://doi.org/10.1023/A:1021149914161
Issue Date:
DOI: https://doi.org/10.1023/A:1021149914161