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Production & Manufacturing of Vaccines - Day 2

 

Pre-Conference Workshop |  Day 1  |  Day 2  |  Download Brochure 

Tuesday, August 18, 2009

7:30am Morning Coffee (Breakfast Sponsored Presentation Opportunity Available)


SCALING UP PRODUCTION

8:25 Chairperson’s Remarks

Rodney Carbis, Ph.D., Head, Vaccine Development, International Vaccine Institute

8:30 Towards a Commercial Production Platform for RSV Vaccine Production

Philippe-Alexandre Gilbert, Ph.D., Senior Scientist, MedImmune Vaccines

Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract disease in infants and young children. MedImmune is currently developing a platform to support the production of a live attenuated, temperature sensitive vaccine against RSV. We developed a robust cell growth and virus production process using Vero cells that were grown on Cytodex 1 in a 2 L stirred tank bioreactor and in a medium free of components of human or animal origin. The experimental results for cell growth and MEDI-559 virus production kinetics will be presented and our efforts in scale-up using a simple P/V model will be discussed.

9:00 Rapid Manufacturing of Vaccines Using Lentiviral Vector Technology

Robert Keefe, Ph.D., Director, Vaccine DevelopmentLentigen Corp.

Lentiviral vectors are highly efficient mediators for the generation of mammalian cell lines that express proteins, antigens or VLPs of interest. We have developed production methods that can efficiently produce several candidate proteins or vaccines. Case studies with data will be discussed.

9:30 Fast Track Development and Scale Up of Recombinant Microbial Vaccine Proteins

Bo Kara, Director, Science and Technology, Avecia Biologics

Increasing process productivity and reducing cost-of-goods are easy to identify as ongoing improvement targets, but of equal importance is the need to reduce the time-lines to move to clinical development. Starting with the gene of interest, the process flow uses the pAVEwayTM platform - expressing the protein in a pre-defined set of vectors, cloning these in a range of corresponding host strains and growing them in a selection of pre-established generic optimal conditions. Examples of how this has been used to establish high-titre scaleable fermentation processes, quickly, will be presented.

10:00 Networking Coffee Break with Exhibit and Poster Viewing


BIOREACTOR SYSTEMS & DISPOSABLES TO OPTIMIZE PRODUCTION

10:45 Utilizing Advanced Hollow Fiber Automated Bioreactor Systems for the Production of High-Fidelity, Patient-Specific Immunotherapies and Biologics

Mark Hirschel, Ph.D., Chief Scientific Officer, Biovest International, Inc.

AutovaxID™ bioreactors represent an example of how advanced hollow fiber technology can play an integral role in the manufacture of personalized vaccines, as demonstrated by this system’s efficiency in the production of BiovaxID®, a late-stage autologous anti-tumor vaccine. In comparison to error-prone manual techniques or minimally-customizable large-tank systems, the AutovaxID makes possible the parallel, high-throughput synthesis of highly individualized immunotherapeutics.

11:15 An Alternate Approach to Influenza Vaccine Production in Cell Culture

James Robinson, M.S., Vice President, Technical and Quality Operations, Novavax, Inc.

Novavax, Inc. is developing a novel vaccine using insect cell culture and recombinant baculovirus to rapidly make three proteins specific to an emerging influenza strain that self-assemble into an enveloped, non-infectious particle resembling the influenza virus (Virus-like particles or VLPs). The use of disposables provides an economic advantage allowing distributed manufacturing with facilities that can be built for a fraction of the cost and time of traditional vaccine plants. The economics and opportunities of influenza vaccine production with single use systems will be described in this talk.

11:45 Implementing a Fully Disposable Downstream Purification Process for Vaccines Using BioSMB Technology

Marc Bisschops, Ph.D., Scientific Director, Tarpon Biosystems

The talk offers a solution to a fully disposable processing train for vaccine production by using a novel downstream processing approach which maintains current separtations chemistries while adding efficiency and decreasing the cost of the process. BioSMB allows one to cycle chromatographic media to make it economically viable to dispose of after a single run or campaign.

12:15pm End of “Novel Vaccines: Design & Development” and “Production & Manufacturing of Vaccines” meetings