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THURSDAY, APRIL 9
12:00pm Conference Registration
1:30 Chairperson’s Opening Remarks
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Keynote Presentation
1:40 Amyloid Structure in Bacterial Inclusion Bodies
Salvador Ventura, Ph.D., Associate Professor, Institute
of Biotechnology, University of Barcelona
Protein misfolding and aggregation have become extremely
active areas of research in recent years. Of particular interest is the
deposition of polypeptides into inclusion bodies inside bacterial cells because
it constitutes a major bottleneck in protein production, restricting the
spectrum of available protein-based drugs or three-dimensional protein
structures. Now, we demonstrate unequivocally the existence of amyloid
structures inside bacterial inclusion bodies. Moreover, we have been able
to show that protein aggregation into inclusion bodies display an important
specificity, that the inclusion bodies are able to seed the formation of amyloid
fibrils and the formation of SDS-stable oligomers of this peptide inside
bacteria. These results suggest the existence of evolutionary conserved
strategies to avoid the harmful effects of undesired protein aggregation by
sequestering sticky folding intermediates into conformationally related stable
aggregated structures through selective interactions in both eukaryotes and
bacteria, highlighting that prokaryotic systems should be seriously considered
when exploring the in vivo determinants and cellular effects of protein
aggregation.
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2:10 Endotoxin Removal from Biopharmaceuticals – A Challenge in Downstream Processing?
Stefan R. Schmidt, Ph.D., M.B.A., Associate Director, R&D, AstraZeneca ABL
Today biopharmaceuticals are important therapeutics. For the manufacturing of protein drugs, various expression systems are used that can potentially be sources of endotoxins. One of the challenges in downstream processing is the reliable quantitative removal of endotoxins, and a number of technologies promise to solve this problem. This talk reviews the current approaches with regard to important parameters (e.g. efficiency, cost, processing time, compatibility), describes a novel scaleable technique, and gives recommendations for typical cases.
2:40 High Performance Simultaneous Clarification and Capture Chromatography
Lisa Crossley, President & CEO, Natrix Separations
2:55 Sponsored Presentation II (Opportunity Available)
3:10 Refreshment Break in the Exhibit Hall
4:00 A Case Study on Effective Strategies for Tech Transfer in Biopharmaceutical Manufacturing
Robert J. Broeze, Ph.D., President & CEO, Laureate Pharma, Inc., Princeton, NJ, and
Thomas P. Loisel, Ph.D., Associate Director, Process Development, Enobia Pharma Inc.
Tech transfer is an essential part of the development of every biopharmaceutical product as it moves from discovery to clinical and commercial production. Examples of effective strategies for efficient tech transfer will be illustrated with a case study of a monoclonal antibody biopharmaceutical. Transfer of technical know-how occurs throughout the development process from early developmental studies to process scale-up and transfer from client to CMO, through internal transfer from development and into cGMP production. Aspects of communication, interaction, facility design and logistics will be addressed.
4:30 Technology Transfer to Manufacturing: The Key to Successful Commercialization
Stephen M. Perry, President, Kymanox Inc.
Success in protein manufacturing, and ultimately in the biotechnology business, is fundamentally linked to the technology hand-off to manufacturing. There are distinct differences between development and manufacturing groups and these differences must be managed actively to ensure transfer success. Furthermore, scale-up and transfer of protein processes have many potential pitfalls - some of which can be avoided when the right plan is in place. Lastly, technology transfer is a knowledge and communication activity where soft skills are as important as technical ones.
5:00 Close of Day
For more information, please contact:
Mary Ruberry
Conference Director
Cambridge Healthtech Institute
Phone: 781-972-5421
E-mail: mruberry@healthtech.com
For sponsorship and
exhibit information, contact:
Carol Dinerstein
Cambridge Healthtech Institute
Phone: 781-972-5471
E-mail: dinerstein@healthtech.com
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