September 2008

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…

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…

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…

Higher-Order Structure Comparison of Proteins Derived from Different Clones or Processes

Biological product manufacture is a complex process that constantly evolves throughout the lifecycle of each product even after its approval. A number of constraints (such as increased yield, scale-up, or a need for greater purity) can necessitate the redesign or optimization of a given process. Heterogeneity of a biopharmaceutical product at the beginning of its shelf life comes from inherent variations in its production process that lead to various forms of posttranslational modifications and degradation products. Clearly, the foremost aim…

Third International

Over the past 25 years, the biopharmaceutical industry has transformed itself from a largely R&D enterprise to a global product economy with rapidly growing sales and regulatory approvals worldwide. Some 125 new biologics are expected to hit the market in the next 10 years. This transition from R&D to manufacturing has placed an enormous strain on existing biomanufacturing expertise and production capacity. India presents a huge opportunity for biopharm companies trying to meet this challenge with its competitive labor cost,…

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…