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Pre-Conference Workshop | Day 1 | Day 2 | Download Brochure
Sunday, August 16, 2009
Pre-Conference Short Courses2:00-5:00pm – Separate Registration Required
Short Course #1: Vaccine Business Opportunities: Collaborations, Mergers and Acquisitions
Successful Strategies for your Product and Technology
For full programming, please click here
Short Course #2:
Managing Process Change in Vaccine Manufacturing
Successful regulatory submissions throughout the product life-cycle
Monday, August 17, 2009
7:30am Registration and Morning Coffee
8:20 Chairperson’s Opening Remarks
William M. Egan, Ph.D., Vice President, PharmaNet Consulting
8:30 Plenary Keynote Presentation
Vaccines: Challenges for the Future Norman Baylor, Ph.D., Director, Office of Vaccines Research & Review, CBER, FDA
9:15 Plenary Featured Presentation:
Risk-Based Modelling for Vaccine Supply Chain Capacity AssessmentSusan Behrens, Ph.D., Senior Director, Biological Sciences & Strategy, Merck & Co., Inc.Vaccine manufacturing requires a series of complex productions steps to deliver final product to meet customer demands. It is important to consider both uncertainty in demand and impact of operational risks on supply when establishing the appropriate capacity targets for capital investment. A Monte-Carlo based model has been used to compare the potential for under-utilized assets, which will result in increased cost of goods to insufficient capacity, which can result in lost revenue. The basic considerations for supply chain design will be reviewed as they relate to the capacity assessment model.
ENSURING QUALITY & SAFETY
AROUND THE WORLD
11:00 Chairperson’s Remarks
R. Barry Holtz, Ph.D , Principal, Holtz Biopharma Consulting
11:05 Essential Quality Considerations for Today’s Manufacturing of Vaccines: The Do’es and Don’ts for Successful Audits and Inspections
Ronald Marchesani, Ph.D., Head, West Coast Operations, Biologics Consulting Group, Inc.
This talk will address the specific quality attributes needed during the different developmental production phases in vaccine manufacturing. Topics will include what are the latest areas of deficiencies noted during regulatory inspections and how to prevent similar deficiencies from occurring in your manufacturing activities. I will also discuss what is really needed during the developmental phases of vaccine manufacturing.
11:35 Development and Technology Transfer of Vaccines for Use in Developing Countries
Rodney Carbis, Ph.D., Head, Vaccine Development, International Vaccine Institute
IVI has recently transferred the technology to produce an oral inactivated whole cell cholera vaccine to an Indian vaccine producer. An investigation revealed several areas for concern in relation to compliance of the vaccine with WHO testing requirements. The first part of the presentation will describe the development of assays to ensure that the vaccine was safe and that the formulation of the vaccine was based on a reliable antigen quantification assay. Additionally other changes in the manufacturing process were made in order to comply with cGMP. The second part of the presentation will describe the process of transforming a typhoid vaccine produced in a research laboratory to a vaccine that can be produced at large scale and manufactured under cGMP conditions.
12:05pm Safety Testing of Novel Virus Vaccines in Europe
Daniel Galbraith, Ph.D., Head, Operations, BioOutsource Ltd.
The testing and characterisation of novel virus vaccines in the European Union will be discussed, including regulatory guidelines and practical considerations. Case studies will be presented from vaccines products newly introduced in Europe. This talk will address the regulatory environment in Europe for an American audience in order to shed light on the concerns of European agencies. Europe is a market that is as large as the United States, and therefore crucial for vaccine manufacturers.
12:35 Lunch on Your Own (Lunch Presentation Opportunity Available)
OPTIMIZING PRODUCTION STRATEGIES
1:55 Chairperson’s Remarks
2:00 Development of an Economic Production Platform for Live Attenuated Influenza Vaccines
Yi Liu, Ph.D., Scientist II, Purification Development, MedImmune, LLC
With the increasing demand for the numbers of flu vaccine doses produced and distributed every year and potentially uneven level of vaccine demand in the event of a pandemic, the egg-based manufacturing process is facing an unprecedented challenge. MedImmune has developed a cell culture-based production process to meet the challenge. The process was demonstrated for its scalability up to 400 L as well as its robustness against various strains. It is proposed to be the production platform for our live attenuated influenza vaccines.
2:30 Development and Manufacturing of Patient Specific Vaccines and Therapies for Cancer Treatment.
This talk will focus on the development of several patient specific approaches to cancer therapy including autologous vaccines, xenograft amplification for vaccine production, and DNA therapy based on individualized proteogenomic analysis. The use of modular production areas and concomitant process and product development has led to a rapid path to early-stage human clinical trials. Proteogenomic analyses have provided insight into individual opportunities for patient treatment. The quality assurance of proteogenomic analysis as a production tool will be discussed.
3:00 A Novel Technology for Simultaneous Clarification & Capture Lisa Crossley, President & CEO, Natrix Separations, Inc.Natrix Separations has developed a membrane-based, crossflow chromatography technology that allows users to capture target molecules directly from unclarified feedstreams. Simultaneous clarification and capture streamlines downstream processing, improves yields and purities and reduces manufacturing costs. This workshop will provide an overview of the Natrix Crossflow Chromatography Technology and will present case studies for the production of vaccines directly from unclarified feedstreams.
3:15 Networking Refreshment Break with Exhibit and Poster Viewing
4:00 Application of Embryonic Stem Cells for the Industrial Manufacture of VaccinesMajid Mehtali, Ph.D., Chief Scientific Officer and General Manager, VIVALISEmbryonic stem cells hold exceptional biological properties that could theoretically be exploited for the derivation of new generations of cell substrates that fulfill modern industrial and regulatory requirements for the production of vaccines. Stable cell lines, called EB66 cells, have been derived from duck embryonic stem cells and were demonstrated to grow in suspension in bioreactors to high cell densities in serum-free media, and to be susceptible to a wide range of human and animal vaccines. Controlled cell banks were generated and a biological master file was filed with the FDA. The cell line is already licensed to over 23 companies worldwide for the production of vaccines or proteins.
4:30 Development of a Commercial Production Platform for the Marine Immune Response Modifier Protein, Keyhole Limpet Hemocyanin, for Use in Therapeutic VaccinesDavid Spaulding, Ph.D., Chief Technology Officer, Stellar BiotechnologiesKeyhole Limpet Hemocyanin (KLH) is a highly effective biologic immune response modifier, and is employed as a carrier protein for antigen conjugates in several therapeutic vaccines that are in the advanced stages of clinical testing. We will review the production technologies and processes that have been developed for KLH, including methods for the control of gametogenesis, hatchery production, and husbandry of the source animal; non-lethal hemolymph extraction from production stocks; and GMP processing and testing of the purified KLH protein to meet the quality requirements of therapeutic vaccines.
5:00 Speaker to be Announced
5:30-6:30 Reception with Exhibit and Poster Viewing
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