- 2:10 PM

Approaches to Efficient Pre-Clinical Process Development

Sandeepa Sandadi, Schering-Plough Research Institute, 1011 Morris Avenue, Union, NJ 07083

Pre-clinical process development for the production of monoclonal antibodies is generally accomplished through small scale experiments, investigating a variety of factors. The number of experiments to test all the factors of interest using the “one-factor-at-a-time approach” can be daunting. The efficiency of process development can be improved by developing “platform expertise” using statistical designs. The design of experiments approach can expedite process optimization. The quality of the product of interest should be considered for the choice of optimum process conditions. The bioprocess thus developed can be used for large scale batch and fed batch operations. The supplementation of culture medium with plant derived hydrolysates using response surface designs will be discussed in order to demonstrate the utility of this approach.