Create Unique End-to-End Bioprocessing Solutions that Guarantee Reproducible Results and Manufacturing Success

Biopharmaceutical Development & Production Week

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March 30-02, 2015 * Hyatt Regency Huntington Beach Resort & Spa, Huntington Beach, CA

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Keynote Presentations

Keynote Presentations

Session Highlights

  • Keynote or Featured Presentation
  • Case Study
  • New Data
  • Panel Discussion

Keynote Presentations

Monday, March 30, 2015

7:00
Registration and Coffee

8:00
Chairperson's Opening Remarks
Günter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, Biotechnologies R&D, GE Healthcare Life Sciences, Sweden

8:15
James Swartz, Ph.D. Engineering Novel Proteins and Protein Assemblies as Innovative Therapeutics, Vaccines, and DrugDelivery Vehicles
The exciting emergence of bispecific antibodies and antibody drug conjugates as new, important classes of protein therapeutics paves the way for developing new families of novel, relatively complex therapeutics. This includes protein assemblies containing multiple copies either of the same or of different proteins as well as protein complexes displaying and/or containing other types of molecules. It is clear, however, that the assembled product form must be consistent and must remain stable during storage and administration. We are now developing modular vaccine forms designed to mimic viruses while also triggering immune stimulation mechanisms evolved to fight bacterial infections. A novel influenza vaccine candidate is comprised of a precisely assembled virus-like particle (VLP) composed of 240 subunits to which multiple copies of a trimeric hemagglutinin stem antigen have been attached with a precise presentation orientation. Finally, a DNA oligomer is co-attached to stimulate an innate immunity thereby maximizing the protective response to the antigen. In this talk, I will describe the precautions taken during the development of this new entity to ensure that a uniform and stable product results. Multiple mutations as well as careful process development were required to enhance folding and assembly of both the VLP and antigen monomers as well as to stabilize the multimeric assemblies. I will then describe how the same approach is being used to develop multi-functional drug delivery vehicles using specially engineered VLPs.
James R. Swartz, Ph.D., James H. Clark Professor, School of Engineering, and Professor of Chemical Engineering and of Bioengineering, Stanford University

9:00
Dana Andersen, Ph.D. Challenges and Opportunities in Pharmaceutical Development
Increasing needs to improve the efficiency of development together with new opportunities such as Breakthrough Therapy designation, will require novel approaches and innovations to be successful. Specific examples and opportunities will be discussed focusing on drug product development but many of which are more broadly applicable as well.
Dana C. Andersen, Ph.D., Senior Director, Pharmaceutical Development, U.S. Biologics Technical Development, Genentech - a Member of the Roche Group

9:45
Networking Refreshment Break in Poster and Exhibit Hall

Wednesday, April 1, 2015

7:30
Registration and Coffee

8:00
Chairperson's Remarks
Uwe Gottschalk, Ph.D., Chief Technology Officer, Pharma Biotech, Lonza, Switzerland

8:15
Tae Han Kim Manufacturing in a Global Market Place
As the CEO of leading contract manufacturing organization - Samsung BioLogics, Dr. TH Kim presents the implication of manufacturing segment in the whole business value chain of biopharmaceutical industry. Beginning with the trend forecast of growing demand and supply of manufacturing capacity, he talks about the limitation of in-house manufacturing and a solution to manufacturing optimization in global market place.
Tae Han Kim, Ph.D., President and CEO, Samsung BioLogics

8:45
Hitto Kaufmann, Ph.D. Innovation in Biologics Manufacturing
Hitto Kaufmann, Ph.D., Vice President, Technology and Innovation, Sanofi Biologics, Germany

9:45
Networking Refreshment Break in Poster and Exhibit Hall

BPI 2015

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