September 2008 Supplement

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 and proteins. The Npro fusion technology is highly suitable for difficult-to-express molecules (e.g., toxic peptides and proteins). Quantitative autoproteolytic cleavage at the desired and authentic N-terminus is simply induced by changing buffer conditions without costly additives or additional process enzymes. Furthermore, the fusion partner may be used for integrated bioprocessing (b...

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 will be most interested in the subject matter of your discussion session (Biosimilars: Where Are We Now?), and what do you expect them to “take away” with them? Anyone interested in the topic of biosimilars will be interested in this session. We will cover the technical, regulatory, and economic challenges faced by companies attempting to seamlessly transition biosimilar replacement products into the marketplace. The “take-away” messages from this workshop will be ideas and approaches to biosim...

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 in Germany How long have you worked for your current employer, and where did you work before that? 1991–2004 Bayer Health Care, head of GMP purification; 2004–today Sartorius Stedim Biotech, VP purification technologies What degrees do you hold, and from where? PhD in immunochemistry When and why did you get involved in the biotechnology industry? What interested you most about it? main interest in downstream processing of monoclonal antibodies What kinds of titers (e.g., 0.5 g/L, 1 g/L...