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View Sub-Track: Vaccines
Thursday, March 27, 2008
BIO-8: WORKSHOP: Aseptic Processing and Manufacturing: From Compliance to Contamination to Control 9:00AM - 11:00AM (Thursday, March 27, 2008)
This session will cover a spectrum of issues related to aseptic processing and manufacturing. Dr. Vadheim will give an overview of regulatory and compliance guidelines as well as point to a scientific overview of critical issues pertaining to aseptic processing manufacturing. Dr. Ashtekar will focus primarily on success stories around the manufacturing of bacterial and viral derived vaccines as well as discuss potential microbial incursions into the manufacturing process. Dr. Sidhu will present case studies linking contamination issues to the aseptic environment as well as solutions for such. Mr. Guardino will focus on the latter as far as disinfectant challenge efficacy and case studies where manufacturing shutdowns have been resolved through the most effective disinfectant/sanitization challenge.
Moderator:
Jaspreet Sidhu, PhD - VP, Business Development and Pharmaceutical Microbiology, Molecular Epidemiology, Inc. (MEI)
Speaker:
Dilip Ashtekar, PhD - Chief Microbiologist for Operations and Director, Global Microbiology, Amgen
BIO-12: Economics of Vaccine Production Using Virus-Like Particles 2:00PM - 3:00PM (Thursday, March 27, 2008)
Virus-like particles (VLPs) made by recombinant techniques using single use disposable equipment offer significant advantages over the traditional vaccine manufacturing approach. This manufacturing method results in lower capital and operating cost and greatly reduced time to market. This presentation provides an overview of the VLP manufacturing process and describes what a commercial facility might look like. Capital and operating costs are estimated and compared to conventional vaccine manufacturing processes. An update on the status of this developing technology is also provided.
Speaker:
Robert Bader - Sr Mgr Technology Pharmabio, Jacobs Engineering
James Robinson - Vice President of Preclinical and Quality Operations, Novavax, Inc.
BIO-13: Design Alternatives for Multi Product Vaccine Facilities 3:15PM - 4:15PM (Thursday, March 27, 2008)
Designing a multi product vaccine cell culture facility is a critical activity that must evaluate many factors in order to identify and meet all design objectives in a timely and cost efficient way. The design must ensure sufficient built in process capability and adaptability for the almost inevitable modifications that future processes will bring, while still keeping a limit on capital commitments. Then what are the design options to achieve requirements for product segregation, containment, work flows and GMPs and how have they been used in recent cell culture projects? Based on a series of large scale cell culture projects, the presentation uses case studies to illustrate design alternatives and discuss the pros and cons of these approaches. The case studies cover facility designs ranging from pilot plant to production scale and are selected to illustrate alternatives in modern vaccine facilities
