Scale and Bioreactor Design Translation for Rocking Bag Bioreactors

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
2011 AIChE Annual Meeting
AIChE Annual Meeting
October 19, 2011 - 8:00pm

Scale and Bioreactor Design Translation for Rocking Bag Bioreactors.

The translations of scale and bioreactor designs for disposable rocking bag bioreactors are currently performed intuitively or with trial an error approaches.  Conditions are typically based on manufacturer recommendations or historical usage. A momentum based fluid dynamic analysis of rocking bag bioreactors provides the foundation for estimating the mixing conditions, the gas transfer rates and the shear environment in the bioreactor. Few assumptions are needed, and fundamental, well established understandings of fluid flow provide quantitative descriptions of various phenomena.

This work focused on WAVE" (GE Healthcare) bioreactors, but is directly applicable to other 2D rocking bioreactors.   Detailed descriptions of system geometry are required for a full analysis, but the calculations can be easily performed in Excel".   Approximations were also developed for the most common operating conditions that provide heuristics for understanding and predicting behavior with operational and bioreactor changes. 

The results obtained from the approach was compared with literature data and observations of rocking bag bioreactors from 2-L to 500-L, include those used in manufacturing.  The analysis predicted well most important bioreactor aspects of bioreactor performance, including oxygen transfer limitations with scale, mixing issues with fill volume, similarity of conditions to stirred tank bioreactors and micro-carrier attached cell damage.  With this understanding of the fluid mechanics, performance variations during scale-up and site changes can be anticipated and addressed, and proper operating parameters can be set.

                                                                                

Development scientist and engineers who are using, or are evaluating rocking bag bioreactors.  Any one who needs to understand the operating principles of  this type of disposable bioreactor.

Education:

Ph. D. Chemical Engineering, PrincetonUniversity;  B. S. Chemical Engineering, Carnegie-MellonUniversity

Experience:

18 years of bio-pharmaceutical equipment and process design, process scale-up and process modeling experience at Merck / Schering-Plough in cell culture and downstream purification.

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