September 2008

An Inoculum Expansion Process for Fragile Recombinant CHO Cell Lines

Development of robust inoculum expansion procedures from cell banks is crucial to successful upstream manufacturing processes. Typically, vial thaw and cell culture expansion processes follow well-established procedures. Certain recombinant cell lines, however, need extra attention and development efforts to optimize conditions for robust and reproducible vial thaw and further subculturing. Difficulties in thawing frozen cells might be clone specific or could originate from suboptimal conditions during freezing. Such conditions might not be known initially and could need further optimization at…

Scaling Up from Bench through Commercialization

Q&A with the Scientific Advisors THOMAS C. RANSOHOFF vice president and senior consultant at BioProcess Technology Consultants, Inc. How long have you worked for your current employer, and where did you work before that? I’ve worked for BioProcess Technology Consultants for six years (since 2002). Before joining BPTC as a senior consultant, I held senior positions in manufacturing, development, and operations for several biotechnology companies including Repligen, Dyax, and TranXenoGen. What degrees do you hold, and from where? I hold…

Proactive Debottlenecking

It wasn’t so long ago that people in the biotherapeutics industry talked about a “capacity bottleneck” to describe the difficulty faced by bioprocessors as their many products moved forth through development to require production at larger and larger scales (1). Expression technologies at the time were making proteins at levels suggesting that huge amounts of manufacturing capacity would be needed soon. Just after the turn of the century, product titers (in terms of protein present per liter of culture broth/supernatant)…

Production and Economics of Biopharmaceuticals

Q&A with the Scientific Advisors HOWARD L. LEVINE president of BioProcess Technology Consultants, Inc. How long have you worked for your current employer, and where did you work before that? I’ve worked for my current employer since 1994. Before BioProcess Technology Consultants, I worked as vice president of manufacturing operations for Repligen. What degrees do you hold, and from where? PhD in chemistry from the University of Chicago (1978); BS in chemistry from the University of Southern California (1975) Who…

Managing the Analytical Lifecycle for Biotechnology Products

Biotechnology pipelines have demonstrated significant growth over the past decade, with many therapeutic candidates evolving in a single class of protein molecules: the monoclonal antibodies (MAbs). To develop such therapeutic candidates, a scalable drug development process must leverage in-house and industry-wide knowledge so biotechnology companies can address the economic and medical needs of 21st-century medicine. Biotherapeutics development is complex, resource intensive, and time consuming, taking some 10 years of effort to go from target validation to commercialization. This reality, coupled…

Cell Culture and Upstream Development

Q&A with Scientific Advisor Dennis Kraichely How long have you worked for your current employer, and where did you work before that? When and why did you get involved in the biotechnology industry? What interested you the most about it? Since 2001, I have worked for Centocor R&D, Inc. (a Johnson & Johnson Company) located in the greater Philadelphia, PA area. Prior to that I worked in cardiovascular discovery research at Procter & Gamble Pharmaceuticals in Cincinnati, OH. Being trained…