432e Production of Growth Hormone Receptor Antagonist In Nicotiana Tabacum Cells: Process Development, Optimization, Scale-up and Technology Transfer

Seshu Tyagarajan and Venkatesh Srinivasan. BioProcess Development, Phyton Biotech, 279 Princeton Hightstown Road, East Windsor, NJ 08520

Production of recombinant Growth Hormone Receptor Antagonist in Nicotiana Tabacum cells serves as a model for production of O-Glycosylated Arabinogalactan proteins in plant cell culture. Data presented indicates efforts involved in process development as well as process optimization, leading to a 10-100 fold increase in protein titers. Experimental design and strategy involved a good understanding and implementation of the pilot scale and large scale manufacturing conditions, such as mixing, dissolved oxygen and air flow. Process development was also carried out with a view to simplifying the downstream processing requirements. As a result of comprehensive understanding and integrated process development efforts, results obtained show identical titer progression at all three levels, namely, lab scale, pilot scale and manufacturing scale.