Simple Strategies to Improve Bioprocess Pure Culture Processing
Reprinted from PHARMACEUTICAL ENGINEERING® The Official Magazine of ISPE May/June 2010, Vol. 30 No. 3 Pure Culture Bioprocessing www.ISPE.org ©Copyright ISPE 2010 This article presents Simple Strategies to Improve strategies to improve Bioprocess Pure Culture Processing bioreactions by reducing contaminations by Michael Hines, Chris Holmes, and Ryan Schad by adventitious agents. ioreaction and fermentation processes of traditional bioprocess reactors and fermenta- of all scales – from 100,000 liter vessels tion processes. They are targeted squarely for to small development reactors – require the practitioner in their simplicity, and based pure culture for their successful, pro- on many years of managing pure culture opera- Bductive operation. In this article the term “pure tions at many scales. The focus of this article culture” and “pure culture capability” will be is on preventing bacterial contaminations in used instead of “sterile” or “sterility assurance” traditional fermentation systems; much of the to acknowledge that bioreactions are, by nature, material applies to protection of any bioreactor the process of growing large populations of systems from any adventitious agent. It is up to helpful microorganisms or cells as opposed to you to understand your system and process and the more unwanted varieties. Contamination to appropriately apply the principles outlined in by adventitious agents costs time, money, and order to meet the requirements of your process lost productivity; moreover, contaminants and and business. Higher potential risk from longer their sources can be very difficult to locate and growth times, longer inoculum trains, and lack eliminate. of selective agents (e.g., antibiotics) can be offset Many elements of pure culture bioprocess through the use of disposables, newer equip- design and operation are straightforward, often ment, and more stringent environmental and even a matter of common sense.
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