Characterisation and scale-up considerations of single-use bioreactors

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ESACT Meeting 2011 in Vienna
Dr. Gerhard Greller, Director Upstream Technology, Sartorius Stedim Biotech
www.sartorius.com
During the last decade the advent of larger scale single use process solutions have changed our approach to making proteins from cell cultures dramatically. Driven by a growing pipeline of biopharmaceutical drugs in development and the cost pressure that the Pharma industry is experiencing, more and more companies are adopting single use bioreactors up to and beyond the 1000L scale. A similar trend can be observed in downstream processing although probably less matured yet. Membrane adsorption lends itself to single use applications with the potential of combining cell removal, clarification and capture into one unit operation.
Towards a fully single use protein production facility
A number of companies have already taken the step and implemented hybrid or even single use production facilities for monoclonal antibodies or vaccine production. Saleability of the process and consistency of results from bench-top bioreactors used in process development and as scale-down models in process validation to commercial scale production bioreactors is a key prerequisite for successful drug development. Therefore, ideally the design of the single use bioreactors should be as close as possible to the full scale systems to reduce the number of variables that may influence product quality and process performance.
Finally, with all this different disposable solutions used in GMP production, not only the vendor -- user relationship has changed but also the approach to validation of single use equipment such as bioreactor bags and containers for process fluids.