SYMPOSIA PAPER Published: 01 January 1996
STP14713S

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

Source

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.

Author Information

Sniff, KS
Process Development group, Amgen Boulder Inc., Boulder, CO
Garcia, LA
Process Development group, Amgen Boulder Inc., Boulder, CO
Hassler, RA
Process Development group, Amgen Boulder Inc., Boulder, CO
Seely, RJ
Process Development group, Amgen Boulder Inc., Boulder, CO
Young, MD
, Boulder, CO
Price: $25.00
Contact Sales
Related
Reprints and Permissions
Reprints and copyright permissions can be requested through the
Copyright Clearance Center
Details
Developed by Committee: E48
Pages: 97–106
DOI: 10.1520/STP14713S
ISBN-EB: 978-0-8031-5322-6
ISBN-13: 978-0-8031-2405-9