(696c) Scale and Bioreactor Design Translation for Rocking Bag Bioreactors

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,
Princeton University;  B. S. Chemical Engineering,
Carnegie-Mellon University

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.