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The roles of a process development group in biopharmaceutical process startup

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.

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References

  1. Andersen DC, Swartz J, Ryll T, Lin N & Snedecor B (2001) Metabolic oscillations in an E. Coli fermentation. Biotechnol Bioeng 75: 212–218.

    Google Scholar 

  2. Birch JR, Boraston R & Wood L (1985) Bulk production of monoclonal antibodies in fermenters. Trends Biotechnol 3: 162–166.

    Google Scholar 

  3. 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.

    Google Scholar 

  4. Goochee CF & Monica T (1990) Environmental effects on protein glycosylation, Bio/Technology 8: 421–427.

    Google Scholar 

  5. Hu, W-S & Aunins JG (1997) Large-scale mammalian cell culture. Currt Opin Biotechnol 8: 148–153.

    Google Scholar 

  6. Pisano GP (1997) The Development Factory. Harvard Business School Press, Boston.

    Google Scholar 

  7. Swartz JR (1994), U.S. Patent 5,342,763. Method for Producing Polypeptide via Bacterial Fermentation, Issued 8/30/94.

  8. Swartz JR (1996), U.S. Patent 5,487,980. Method of Determining Propensity for Dissolved Oxygen Instability, Issued 1/30/96.

  9. Swartz JR (1997), U.S. Patent 5,633,165. Fermentor with Vertical Shaft, Issued May 27, 1997.

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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

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  • biopharmaceutical
  • manufacturing
  • plantstartup
  • process development
  • process startup
  • process transfer