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 as a molecular biologist, I have always been intrigued by the use of recombinant proteins as therapeutics. I think what has interested me most is the exquisite precision that a monoclonal antibody has for a target antigen and how researchers can take advantage of that feature to develop specific and effective therapeutic agents to treat life-threatening diseases.
Which biologics does your company have currently on the market
—
or in later stages of clinical development? What kinds of production/economicsrelated tools and...
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...
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 BS and MS degrees, both in chemical engineering, from MIT and UC-Berkeley, respectively.
When and why did you get involved in the biotechnology industry?
I had become interested in biochemical engineering at MIT and had an opportunity to join a start-up biotech company called Xoma in California after graduating from UC-Berkeley.
What interested you the most about it?
I enjoy the intersection of the incredible science on which modern biopharmaceutical products are based ...
