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)…
Monday, September 1, 2008 Daily Archives
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…
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…
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…
Reducing Microbial Contamination Risk in Biotherapeutic Manufacturing
The risk of contamination (especially microbiological) is always an area for special attention in biopharmaceutical processes. No matter the process stage, whether upstream of a bioreactor or in the final filling of a sterile product, effective contamination control continues to be a critical requirement, so any opportunities for improvement may justify further investigation. Even with established validated processes, demands for higher purity and increased sterility assurance may require manufacturers to reassess their procedures and technologies. New processes present an even…
Recovery and Purification
Q&A with the Scientific Advisors CHARLES SCHMELZER senior scientist in late-stage purification at Genentech, Inc. How long have you worked for your current employer, and where did you work before that? What degrees do you hold, and from where? I have been working at Genentech since September 1987. I have a BS degree (chemistry) from Rutgers University (Cook College) and a PhD degree (biochemistry) from North Carolina State University. UWE GOTTSCHALK vice president of purification technology at Sartorius Stedim Biotech…
Biotech Facilities Average a Batch Failure Every 40.6 Weeks
Gathering information about batch failure rates in the biopharmaceutical industry is about as easy as getting politicians to talk about their most embarrassing gaffes and indiscretions. Although it comes as no surprise that batches do fail, some readers may be surprised at how relatively well many organizations appear to be performing. Based on the results of our recently released annual report and survey (1), facilities are experiencing batch failures at an average rate of about one every nine months (40.6…
Poster Presentations
Production and Economics Friedrich Nachtmann, head of biotech cooperations in biopharmaceuticals at Sandoz GmbH NAFT: Npro Autoprotease Fusion Technology Microbial expression systems play an important role in the biopharmaceutical industry. A robust, scalable, and well-understood process, reduced development times, and competitive costs are requirements for successful manufacturing. In cooperation with the Austrian Center of Biopharmaceutical Technology, Sandoz has developed a platform Escherichia coli expression technology that provides high expression levels and rapid process development for a broad range of peptides…
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…