Tuesday, July 30, 2013

Development and Qualification of a Scalable, Disposable Bioreactor for GMP-Compliant Cell Culture


Today, we feature an article from our partners at BioProcessing International Magazine.



During the past decade, single-use bioreactors have become widely accepted for use in cell culture process development and clinical manufacturing. Their key benefits over stainless steel bioreactors are flexibility, cost, and time savings associated with the reduction of cross contamination risks (1).

Here, we describe our approach to development and qualification of the Biostat STR single-use, stirred-tank bioreactor. Unlike other stirred single-use bioreactors, it offers a similar design to that of well-established, conventional (stainless steel) stirred-tank bioreactors. Disposability of the single-use cultivation chamber gives it robustness, reliability, and reproducibility of biological results together with a supply assurance needed to meet biopharmaceutical industry requirements.

Development of a single-use bioreactor involves different phases of work (Pictured Left). The starting point should be a clear definition of the product’s intended application. Typically, related requirements are captured in a user requirement specification (URS). On the basis of that initial input, the bioreactor design and material selection are then initiated. The proof-of-concept phase establishes component- and product based tests that are predictive of the final application. Mechanical, chemical, and biological tests can be used to verify compliance with the URS during the prototype feasibility phase. Ideally, the production process should be qualified as well: Qualification efforts should cover production equipment, procedures, and parameters. Final product qualification can be based either on qualification of the individual components or the whole final product (or a combination of both) using mechanical and biological tests that emulate a specific intended application. Typically, this evaluation should be performed using bioreactor bags derived from regular manufacturing. All changes brought about (e.g., performance or robustness improvements) should be controlled by a stringent change-control process.

Download the full article here.

Follow the jump for references.



(1) 1 Eibl R, L√∂ffelholz C, Eibl D. Single-Use Bioreactors: An Overview. Single-Use Technology in Biopharmaceutical Manufacture. Eibl R and Eibl D, Eds. John Wiley & Sons, Inc.: New York, NY, 2011; 33–51.


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