Journal of Bioequivalence & Bioavailability

Expression of a complex biosimilar monoclonal antibody in alternate mammalian host system

International Conference and Exhibition on Biowaivers & Biosimilars

September 10-12, 2012 Hilton San Antonio Airport, USA

Hatim Motiwala

Accepted Abstracts: J Bioequiv Availab

Abstract:

Monoclonal antibodies (Mabs) are now the second largest category of biopharmaceutical products in development and are predominantly manufactured by mammalian cells in culture. Large-scale processes generally employ Chinese Hamster Ovary (CHO) cells as production vehicles, although other mammalian cell types, such as murine lymphoid cells (NS0, SP2/0), are also utilized. Mammalian cell hosts can correctly fold, assemble, and glycosylate Mab polypeptides. The latter is crucial, for example, in the case o f recombinant mAbs that are designed to harness biological activities such as antibody -dependent cell cytotoxicity and complement mediated lysis in vivo. The glycosylation and bioactivity varies from host to host. We have attempted switching the host system to express biosimilar mAb. The main purpose of switching host was to strike a balance between achieving higher productivity and quality as close to the Innovator?s product as well as making a platform expression-host system to make the process economical. In order to achieve this we have selected one of the most complex mAb available in market which possess two glycosylation sites.

Biography :

Hatim Motiwala is a postgraduate in Microbiology and at completion stage of Ph.D. from The M.S. University of Baroda, India. He has 12 years of experience working on biosimilars. His core expertise is in mammalian cell culture with working experience in cell line development, mammalian upstream process development, in-vitro bioassays, technology evaluation and transfer. Currently, working at a post of Senior Scientist and managing three biosimilar monoclonal antibody development programs at Intas Biopharmaceutical Limited. Earlier he was associated with Biocon Biopharmaceuticals, Cadila Pharmaceuticals, Sun Pharma Advanced Research Centre, and Chiron Vaccines Limited (Aventis).