The evolution of a disposable stirred tank bioreactor at Centocor: From concept to GMP implementation

BIOT 239

Wood Christian, CWood@CNTUS.JNJ.COM, Ravinder Bhatia, Nicole Richardson, and Sadettin Ozturk, s_ozturk@earthlink.net. BioProcess Development, Centocor R&D, PO Box 776, Welsh and McKean Roads, , PA, Spring House, PA 19477
Over the last few years, Centocor has been developing a disposable bioreactor system for use in the Development and GMP Pilot Plant Facilities. The project began internally at the 50 L scale, and through collaboration with Hyclone, evolved to a GMP compliant 1000 L bioreactor. Initially, a set of design requirements was established to ensure scalability, and adequate mass transfer and mixing to support cell growth. At each stage of the project, the disposable bioreactors were able to achieve growth and productivity comparable to stainless steel bioreactors. However, several issues and design limitations were encountered which required practical solutions to improve usability and safety, and meet GMP requirements. This presentation will summarize these development efforts, and highlight some of the challenges and solutions which resulted in a fully GMP compliant 1000 L disposable bioreactor system.
 

Poster Session
5:30 PM-7:30 PM, Wednesday, August 22, 2007 BCEC -- Exhibit Hall - B2, Poster

Division of Biochemical Technology

The 234th ACS National Meeting, Boston, MA, August 19-23, 2007