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Mark Your Calendar for 2012
October 8-12, 2012
Rhode Island Convention Center
Providence, Rhode Island
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Vaccine Development & Production
- Agenda overview: Go to the agenda overview to view the detailed agenda for each track or symposium.
- To view the complete agenda: Please download the PDF brochure.
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
Vaccine Development & Production
8:00
Chairperson's Remarks
Scott M. Wheelwright, Ph.D., President, Strategic Manufacturing Worldwide, Inc.
Scott M. Wheelwright, Ph.D., President, Strategic Manufacturing Worldwide, Inc.
Keynote Presentations
8:05
Vac to the Future: Vaccines Bioprocessing and DevelopmentVaccines are the crown jewel in the accomplishments of biotechnology, impacting far more lives at far less cost than any other medical intervention. This talk will discuss the state-of-the-art in vaccine development and manufacturing, current issues, and future trends. Evolution of bioprocess and manufacturing requirements as they relate to products and new potential products will be emphasized.
John G. Aunins, Ph.D., Executive Scientific Director, Merck Research Laboratories
9:00
Public-Private Partnering for National Security & Public Health NeedsRobin A. Robinson, Ph.D., ASPR Deputy Assistant Secretary and BARDA Director, US Department of Health and Human Services
9:45
Networking Refreshment Break in Exhibit and Poster Hall
10:30
What's Different: Manufacturing Vaccines vs. Biotherapeutics
While the basic techniques of manufacturing vaccines and biotherapeutics are essentially the same, there are various aspects of vaccine production that deserve special consideration. In particular, plasmids, live viruses and allantoic fluid all present challenges not present with most biotherapeutics.
Scott M. Wheelwright, Ph.D., President, Strategic Manufacturing Worldwide, Inc.
While the basic techniques of manufacturing vaccines and biotherapeutics are essentially the same, there are various aspects of vaccine production that deserve special consideration. In particular, plasmids, live viruses and allantoic fluid all present challenges not present with most biotherapeutics.
Scott M. Wheelwright, Ph.D., President, Strategic Manufacturing Worldwide, Inc.
11:00
Plant-Based Process for an Innovative and Accelerated Vaccine-Manufacturing Solution
Medicago's technology combines the speed and cost advantages of plant-based transient expression with the efficacy of a VLP-based antigen presentation system. Medicago has used the technology to produce vaccines under cGMP which are under clinical development. More recently, this technology has been down-sized and automated to serve as a high-throughput discovery tool (VLPExpress™) which accelerates the development of new candidate vaccines.
Louis Philippe Vezina, Ph.D., CSO, Medicago Inc., Canada
Medicago's technology combines the speed and cost advantages of plant-based transient expression with the efficacy of a VLP-based antigen presentation system. Medicago has used the technology to produce vaccines under cGMP which are under clinical development. More recently, this technology has been down-sized and automated to serve as a high-throughput discovery tool (VLPExpress™) which accelerates the development of new candidate vaccines.
Louis Philippe Vezina, Ph.D., CSO, Medicago Inc., Canada
11:30
Implementation of Disposable Bioreactors for Viral Vaccine Processes: An Industrial View and Perspective
GSK Biologicals has performed an in-depth testing of the disposable bioreactors available on the market. After having selected a specific single use bioreactor technology as a platform for development and scale-up of new viral vaccines, and having used this technology for viral vaccine production for more than two years, a status in terms of process efficiency, robustness, field of application, revised Cost of Goods, and biosafety will be presented.
Jean-Francois Chaubard, Director Industrial Viral Bulk Production, GlaxoSmithKline Biologicals, Belgium
GSK Biologicals has performed an in-depth testing of the disposable bioreactors available on the market. After having selected a specific single use bioreactor technology as a platform for development and scale-up of new viral vaccines, and having used this technology for viral vaccine production for more than two years, a status in terms of process efficiency, robustness, field of application, revised Cost of Goods, and biosafety will be presented.
Jean-Francois Chaubard, Director Industrial Viral Bulk Production, GlaxoSmithKline Biologicals, Belgium
12:30
Networking Luncheon & Last Chance to Visit the Exhibit and Poster Hall
1:00
Presentation of BPI Magazine Best Poster Award
Vaccine Development & Production
1:40
Chairperson's Remarks
Pete Latham, President, Latham BioPharm Group
Pete Latham, President, Latham BioPharm Group
Unpublished Data
1:45
Process Intensification to Support World Vaccine Delivery
With the process intensification technology Crucell is creating the possibility to grow more production units (the cells) in the bioreactor and are therefore able to decrease the bioreactor size needed for vaccine production. This decrease is not only beneficial for the bioreactor, it also decreases the facility design and therefore the cost of goods.
Alfred Luitjens, Senior Scientist, Process Development, Crucell, The Netherlands
With the process intensification technology Crucell is creating the possibility to grow more production units (the cells) in the bioreactor and are therefore able to decrease the bioreactor size needed for vaccine production. This decrease is not only beneficial for the bioreactor, it also decreases the facility design and therefore the cost of goods.
Alfred Luitjens, Senior Scientist, Process Development, Crucell, The Netherlands
Unpublished Data
2:15
Case
Study
Characterization and Comparability of Candidate Vaccine Antigens Using Biochemical and Biophysical MethodsStudy
Some characterization methods are stability-indicating and are used in stability programs for vaccine components, e.g. protein antigens. The assays chosen for the characterization package are usually linked to key product attributes. Examples will be presented showing how a characterization package is used to assess lot to lot comparability, the impact of process changes, and to demonstrate comparability of the same product manufactured in different facilities.
Marina Kirkitadza, Ph.D., MBA, Deputy Director, Head of Biophysics and Conformation Unit, Analytical R&D North America, Biochemistry Platform, Sanofi Pasteur, Canada
Unpublished Data
2:45
Strategies for Host Cell Protein Immunoassay Development for Recombinant Vaccines
Regulatory authorities are increasingly requesting that residual host cell protein (rHCP) immunoassays supplement traditional measures of vaccine product purity and process consistency such as SDS-PAGE. Strategies for rHCP immunoassay development for recombinant vaccines will be discussed. Reagent generation strategies, assay development, and validation will be emphasized and discussed in the context of regulatory expectations for these highly complex assays.
Marc Thorsteinsson, Ph.D., Research Fellow, Vaccine Analytical Development, Merck and Co., Inc.
Regulatory authorities are increasingly requesting that residual host cell protein (rHCP) immunoassays supplement traditional measures of vaccine product purity and process consistency such as SDS-PAGE. Strategies for rHCP immunoassay development for recombinant vaccines will be discussed. Reagent generation strategies, assay development, and validation will be emphasized and discussed in the context of regulatory expectations for these highly complex assays.
Marc Thorsteinsson, Ph.D., Research Fellow, Vaccine Analytical Development, Merck and Co., Inc.
3:15
Networking Refreshment Break
Unpublished Data
4:00
Case
Study
Development and Preclinical Optimization of a Circumsporozoite Protein (CSP) Vaccine Candidate against Malaria via a Virtual Pharmaceutical ApproachStudy
Operating as an unbiased Virtual-Pharma supporting the NIAID/NIH, SAIC is pursuing the manufacture of a full-length Circumsporozoite Protein as a malaria candidate vaccine. A Psuedomonas platform achieved soluble protein that demonstrated challenge model efficacy. Formulation studies were applied early in scale-up to avoid downstream issues. PD progress and parallel pre-clinical evaluations of adjuvants, VLP and nanoparticle technologies will be presented.
Scott B. Winram, Ph.D., Program Manager, Health Sciences Business Unit/Life Sciences Operation, Science Applications International Corporation
Unpublished Data
4:30
Case
Study
FluBlok: A Novel Influenza VaccineStudy
A Biologics License Application (BLA) for approval of FluBlok, a new recombinant influenza vaccine for the prevention of the "flu", was filed in April 2008. The speaker will discuss the interaction between Protein Sciences Corporation and the FDA during the product review cycle and how the company is preparing for the launch of FluBlok.
Manon M.J. Cox, Ph.D., President and CEO, Protein Sciences
5:00
Case
Study
MAGE-A3 Antigen Specific Cancer Immunotherapeutic nearing Commercialization: Clinical Update and CMC ChallengesStudy
GSK Biologicals is in late stage development of an investigational MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) targeted for treatment of metastatic melanoma and non-small cell lung cancer. The ASCI is a combination of MAGE-A3 recombinant protein with a GSK proprietary adjuvant system containing a CpG oligonucleotide. An update on clinical progress will be presented together with a case study of the post-Phase 3 change made in the manufacture of CpG oligonucleotide. The study will highlight key elements of technology transfer, the regulatory impact of site, process and analytical changes, and learning from engineering and process validation.
Vincent Mancuso, Director, Immunostimulants and Chemistry, GlaxoSmithKline Biologicals, Belgium
5:30
Close of Day Three
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