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This event brings together experts from vaccine manufacturers, suppliers, quality control, and platform development to learn new technologies, network with colleagues and advance the field of vaccine and immunotherapeutic manufacturing. With the advent of new vaccines for both infectious disease and therapeutic use, the challenge for the vaccine manufacturer is to increase productivity, maintain adherence to regulatory requirements and evaluate novel platforms and technologies to stay current. In addition to the technological advances of the field, the increased importance of both U.S. and international regulatory agencies will be addressed as well as the latest in FDA guidance documents and their impact on current production.
Tuesday, August 16
7:20 am Registration & Morning Coffee
8:20 Chairperson's Opening Remarks
Kate Skaare, Conference Producer, Cambridge Healthtech Institute
8:30 New Manufacturing Platforms for Vaccine Production
Vidadi Yusibov, Ph.D., Executive Director, Center for Molecular Biotechnology, Fraunhofer USA
There has been a great deal of development in recombinant protein expression technologies in the past 30 years with a variety of in vivo and in vitro systems emerging. However, the current capacity and cost of production for most recombinant proteins limits their availability. Thus, it is important to evaluate different production systems for each target and choose one that ensures cost-effective worldwide manufacturing capability. The system of choice would ideally produce safe, fully active material at the lowest cost. Important considerations include product safety, yield, specific protein characteristics, storage conditions, containment, set-up and production costs, purification strategies, size of market, environmental concerns, public perception and competing technologies.
9:15 Development and Phase I Manufacturing for a VLP-Based Vaccine for Chikungunya Virus
Richard Schwartz, Ph.D., Chief, Vaccine Production Lab, NIH NIAID
9:45 Novel Platform for Protein Production; Influenza Vaccine Production Using Plant-Based Protein Expression
Brigitte Barbeau, VP Manufacturing, Medicago R&D Inc
10:15 Networking Coffee Break with Exhibit and Poster Viewing
11:00 Building on the Unique Biological Properties of Embryonic Stem Cells for the Industrial Manufacture of Vaccines and Antibodies
Majid Mehtali, Ph.D., Managing Director, CSO, VIVALIS
The unique biological properties of embryonic stem cells (ES), in particular their pluripotency, and ability to replicate indefinitely, have led to intense basic research activities worldwide, as well as to applied research on their potential therapeutic applications in regenerative medicine. We have rather focused on the genetic stability and indefinite self-renewal capacity of ES cells with the aim to develop new cell lines for the large-scale manufacture of biological products. A proprietary process was established that allowed the derivation from ES cells of stable cell lines that maintain the desirable features of ES cells but display additional attractive industrial characteristics (eg. high suspension cell densities in chemically-defined media, rapid development time, high production yields of biological products). The EB66 cell line was derived from duck ES cells and was shown to constitute an effective alternative to the widely used chicken egg for the production of human and veterinary vaccines. In addition, the cell line can be efficiently genetically engineered for the high yield production of monoclonal antibodies with reduced fucose content and enhanced antibody-dependent cell cytoxicity (ADCC) activity. Fully controlled GMP cell banks are available and a biologic master file was filed with the US FDA. Phase I clinical trials are currently ongoing on EB66-produced influenza vaccine candidates. The biological features of EB66 cells as well as examples of vaccines production processes will be described.
11:30 Rapid Production of Influenza Vaccines in Insect Cells: It's All in the Preparation
Daniel Adams, J.D., Executive Chairman, Protein Sciences Corporation
Insect cells, such as Protein Sciences patented expresSF+® cells, coupled with baculovirus vectors is an ideal system for moving rapidly into production. Real time availability of genetic information about potentially interesting influenza viruses from CDC, WHO and TGA among others makes it feasible to prepare and freeze down at minimal cost many, even thousands, of baculovirus vectors long before they are needed, even in the case of a pandemic. The frozen vector can be thawed and ready to infect a bioreactor in less than two weeks, making the insect cell system the fast known system.
12:00 pm Sponsored Presentation (Opportunity Available)
Sponsored by
12:15 Luncheon Presentation
From Discovery to Commercialization: Delivering the Next Generation of Vaccines using High-throughput MicrobioreactorsTiffany D. Rau, Ph.D., Global Technical Manager, Pall Corporation
Today's vaccine organizations must reduce timelines & manage ever-shrinking resources. Data will be presented that illustrates the advantages of controlled "high-throughput" bioreactors for cell line selection and process optimization which allows for rapid, very early stage development which can contribute to shorter timelines and; ultimately, lower development costs.
1:55 Chairperson's Remarks
William Egan, Ph.D., Vice President, Consulting, PharmaNet Development Group
2:00 PRiSM: A Novel Platform for Streamlined Production and Purification of Subunit Vaccines
Theodore Clark, Ph.D., Associate Professor, Microbiology & Immunology, Cornell University
Tetrahymena thermophila is a rapidly growing eukaryotic microbe that can produce fully assembled and correctly folded viral and parasitic proteins at scale. Unique to this system is its ability to produce antigens in the context of a crystalline matrix (termed PRISM) that can be readily harvested by low-speed centrifugation following stimulus-dependent secretion from cells. This process is tantamount to affinity chromatography in vivo and permits rapid, one-to-two step purification of matrix associated proteins. At the same time, the underlying crystalline structure of PRISM itself has the potential to induce very strong immune responses to expressed vaccine antigens in much the same way as VLPs but at a fraction of the cost. This presentation will focus on the production of influenza and malaria vaccine antigens using the PRISM platform.
2:30 Novel Vaccine Manufacturing Platforms – Novel Concerns
William Egan, Ph.D., Vice President, Consulting, PharmaNet Development Group
A variety of new vaccine manufacturing platforms offer a number of potential advantages – including, as examples, more effective vaccines, less costly vaccines, more rapidly produced vaccines. At the same time, however, these manufacturing platforms raise new scientific and regulatory concerns that might potentially affect the vaccines safety or efficacy. For example, novel cell substrates raise anew questions about potential adventitious viral agents. This talk will explore some of the scientific and regulatory challenges that attend the introduction of novel manufacturing platforms.
3:00 Ad 4 Vector Vaccine for H5N1 Influenza
Paul Shabram, M.B.A., Vice President, Operations, PaxVax, Inc.
The production of Ad 4 vector vaccines has been designed for simplicity, scalability, and to utilize single use technologies when ever possible. The PaxVax vision is to develop a room temperature stable vaccine that can be self administered and available to the developed and developing world. PaxVax currently has a pandemic H5N1 flu Ad 4 vector vaccine in clinical trials. The production cell line used is an accepted production system, however for large scale needs, such as a world-wide pandemic, a novel cell substrate is nearing completion of characterization for filing a BMF with FDA. The current status and results of the phase one trial will be summarized.
3:30 Networking Refreshment Break with Exhibit and Poster Viewing
4:15 Current Regulatory Challenges in Vaccine Production
Jane L. Halpern, Ph.D., Vice President, Regulatory Affairs, Novavax, Inc.
4:45 So What's the Problem?
John Rothman, Ph.D., Executive Vice President, Science & Operations, Advaxis, Inc.
Getting regulatory approval to initiate clinical trials in other countries can result in many different kinds of unanticipated difficulties, extremely costly delays and considerable frustration. This talk discusses some of the unexpected problems a small biotech with a very novel technology encountered in Europe and Asia, how they were addressed, and how they were overcome. Suggestions about how to plan for contingencies and possibly avoid similar problems will be offered.
5:15 US Government ADM Centers and Their Impact on Vaccine Manufacturing and Single Use Technologies
Peter Latham, M.S., President, NA, Latham BioPharm Group
The US Government, both at HHS BARDA and the Department of Defense (DoD), has announced intentions of investing in Centers for Advanced Development and Manufacturing. The goal of these centers will be to support both biodefense/pandemic response needs in the times of an emergency and to support the ongoing development of new medical countermeasures (MCMs). The initial stated maximum investments are $1.2B per award over up to 25 years. These centers are likely to have a dramatic impact on both the development and manufacturing of new vaccines (MCM and otherwise) and the future of contract services. Additionally, the initial draft documents call for "advancing state-of-the-art, disposable, modular manufacturing process technologies." This talk will review the current plans and programs at BARDA and DoD, their potential impact on vaccine developers and suppliers, and ways in which those companies can participate.
5:45 MCM/Regulatory Science Initiative -FDA's Response to the Need for Accelerating Medical Countermeasure Development
Alan Liss, Ph.D., Director, MCMi PHSAT, FDA, Office of the Commissioner, Office of Counterterrorism and Emerging Threats - Biography
The events of 9/11 and the subsequent mailings of anthrax-laden envelopes forever changed the way Americans view public health and their personal security. Despite considerable financial and human resource investments since 2001, the United States does not yet have the range of medical countermeasures (MCMs) it requires to rapidly and effectively respond to a deliberate chemical, biological, radiological or nuclear event or to a naturally occurring infectious disease outbreak. To enhance the probability of success, FDA has launched (8/2010) a Medical Countermeasures Initiative to facilitate FDA being engaged from the earliest steps of MCM development. FDA also intends to better define clear, scientifically-supported development pathways, and identify and help fill important scientific and regulatory gaps that often derail MCM development. This talk is a program update noting current progress and continuing opportunities for FDA's active engagement with industry and academic experts to assist advancements in regulatory science that will enable the Nation to successfully develop the next generation of MCMs needed to protect the American people.
6:00 Reception with Exhibit and Poster Viewing
7:00 Close of Day
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