Automation of a multi-dimensional chromatography lab model for the downstream purification of monoclonal antibodies

BIOT 319

William Holmes, holmeswd@lilly.com, Bioprocess Research and Development, Eli Lilly and Company, Indianapolis, IN 00000
Process development of monoclonal antibodies in the biopharmaceutical industry typically includes multiple chromatographic operations. In addition to column operations, processes also include bulk volume operations (BVO?s) which serve to prepare product for column loading, low pH hold step for viral inactivation, etc. We are developing an automated lab model system for use across multi-dimensional chromatography as well as BVO?s for the downstream purification of monoclonal antibody(s) from mammalian cell culture (MCC). This automated lab model platform is flexible in design and utilizes common AKTA Explorer systems. The goal of this work is to apply automation from MCC clarified media all the way up through final bulk API (apart from ultrafiltration) including in process sampling while at the same time applying design of experimentation. Experimental results, various automation strategies, their implementation, and automation improvements are discussed.
 

Poster Session
5:30 PM-7:30 PM, Wednesday, 13 September 2006 Moscone Center -- Hall D, Poster

Division of Biochemical Technology

The 232nd ACS National Meeting, San Francisco, CA, September 10-14, 2006