We have experience in bioreactor design, scale-up and operation including whole cell (i.e. fermentation) and enzymatic (i.e. biotransformation) conversion processes for the production of complex materials such as therapeutic proteins, antibiotics and gene therapy vectors.
An example is the monitoring of batch bioreactors which is a complex task, due to the fact that several sources of variability can affect a running batch and impact on the final product quality. The product quality itself may not be measurable on line, but requires sampling and laboratory analysis which can take several days to yield a result. We have expertise in using appropriate process analytical technology tools and using Quality-by-Design approach whereby the operation of an industrial batch bioreactor can be effectively monitored as the batch progresses. Leveraging historical databases of batches already completed, multivariate statistical models may be built and are used to enable the real time identification of the variability sources and to reliably predict the final product quality enabling improved process understanding and paving the way to a reduction of final product impurities and rejections, as well as to a reduction of the product cycle time.