STP1260

    Process Development, Scale-Up and Validation of a Recombinant E. Coli-Based Fermentation Process

    Published: Jan 1996


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    Abstract

    The goal of validation of a fermentation process is to provide documented evidence that the production process performs as intended. The product from a validated fermentation process should have pre-determined characteristics which indicate the process is performing consistently. Changes in the fermentation process for production of recombinant human interleukin-1 receptor antagonist while in clinical trials included growth medium and extended time after induction. The goals of the development and scale-up activities were to develop a reproducible, scalable process yielding high quality material and to introduce the new process to the manufacturing facility in a timely fashion. In the course of development and scale-up, further modifications were required to maintain reproducibility and product quality. The start-up batches from both the pilot-scale and the production facility provided the data sets for validating the process, establishing the limits for operating variables and the control limits for performance parameters.

    Keywords:

    fermentation, process development, scale-up, process validation, E. coli, recombinant protein


    Author Information:

    Sniff, KS
    Associate scientist, research associate, group leader and research scientist, Process Development group, Amgen Boulder Inc., Boulder, CO

    Garcia, LA
    Associate scientist, research associate, group leader and research scientist, Process Development group, Amgen Boulder Inc., Boulder, CO

    Hassler, RA
    Associate scientist, research associate, group leader and research scientist, Process Development group, Amgen Boulder Inc., Boulder, CO

    Seely, RJ
    Associate scientist, research associate, group leader and research scientist, Process Development group, Amgen Boulder Inc., Boulder, CO

    Young, MD
    Consultant, Boulder, CO


    Paper ID: STP14713S

    Committee/Subcommittee: E48.06

    DOI: 10.1520/STP14713S


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