Sunday, November 8, 2009 - 2:00 PM
S3

Towards the development of a glycoengineeringed yeast cultivation platform for the production of therapeutic proteins

Thomas I. Potgieter, Bioprocess Research and Development, Merck & Co Inc., 126 E. Lincoln Ave, Rahway, NJ 07065

Growth in the therapeutic protein market has fueled the development of alternative expression systems. GlycoFi (a wholly owned subsidiary of Merck & co) has established glycoengineered yeast strains capable of producing therapeutic proteins at economically viable levels with uniform human N-linked glycans.

 A cultivation process development paradigm applied to the production of therapeutic proteins by glycoengineered yeast is presented. A combination of design of experiments, molecular profiling and metabolite analysis are employed in a systematic approach to enable establishment of a process fit for purpose for each of the drug development stages. This approach drives a fundamental understanding of the impact of process conditions on process consistency and product quality in a resource-efficient manner.