Below is a listing of all sessions the speaker is scheduled to present.
Director, Strategic Consulting
CRB Consulting Engineers
Speaker BioKim L. Nelson, Ph.D. is a Senior Associate, and Director of Strategic Consulting for CRB Consulting Engineers. As Director of Strategic Consulting, Kim is responsible for the design of biotech and pharmaceutical projects and consultation on process development, biocontainment and Current Good Manufacturing Practices. Kim is an internationally recognized bioprocess design industry leader with more than 28 years of experience in design and operation of biopharmaceutical facilities. His project experience encompasses domestic and international projects of therapeutic proteins and vaccines, fermentation scale-up and design, and diagnostics products, and specializes in cGMP regulatory compliance, process design and development, and facility design for the biotech, pharmaceutical and medical device industries. Kim has experience in the following technologies: large-scale mammalian cell culture, recombinant microbial culture, bacterial fermentation, plant and insect cell culture, downstream processing and purification. He has also consulted with the FDA on behalf of numerous clients and their facility designs.
Dr. Nelson received dual B.S. degrees in Chemical Engineering and Biochemistry/Biophysics from Oregon State University and his Ph.D. in Chemical Engineering from the University of Delaware. Engineering design experience prior to joining for CRB included management positions with Life Sciences International, United Engineers & Constructors and Quasar Engineering. Operational experience includes Flow Labs and Otsuka Pharmaceutical.
|Wednesday, March 30, 2011|
The baculovirus production technology can support safe and expeditious vaccine production and provides an attractive alternative to the current egg-based influenza vaccine (TIV) manufacturing process. Protein Sciences Corporation was initially awarded a $34.5 million contract in June 2009 for an 18 month period from the U.S. Department of Health and Human Services to further develop this technology for the production of recombinant influenza vaccines for pandemic preparedness with the contract recently extended for another two year period.
The manufacturing process for FluBlok/PanBlok, a recombinant protein based influenza vaccine including the combination of single- and multi-use equipment in the current process will be described.
Possible scenarios for establishing surge capacity range from warm base manufacturing facilities (ready to go when they need to), to facilities used for the production of other products that can be rapidly deployed when needed through a hybrid approach, to fully disposable factories. The panel will evaluate advantages, and disadvantages of each scenario from a financial, regulatory, and engineering perspective.