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Vaccine Production Summit
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Agenda
8:00
Registration and Networking Coffee
8:40
Chairperson's Open Remarks
Anthony W. Baker, Technical Product Leader, Merck Manufacturing Division, Merck
Anthony W. Baker, Technical Product Leader, Merck Manufacturing Division, Merck
Keynote Presentation
8:45
The Regulatory Pathway for Next Generation Adjuvanted VaccinesMany newer vaccine candidates are likely to require the isolation of protective antigens from whole pathogens, as well as new methods to deliver these molecules to induce effective immune responses with minimal adverse reactions. Adjuvants have become an increasingly important ingredient in new vaccines. The absence of relevant animal models and surrogate markers of protection needed to demonstrate efficacy are a major challenge in evaluating adjuvanted vaccines. This talk will discuss the challenges in developing regulatory pathways for evaluating and licensing next generation vaccines.
Norman W. Baylor, Ph.D., President & Chief Executive Officer, Biologics Consulting Group, Inc.; former Director, Office of Vaccines Research and Review (OVRR), US Food and Drug Administration (FDA)
Improving the Quality and Throughput of Vaccine Production
9:30
Manufacturing Considerations for Vaccine Processes
Vaccine manufacturing is complex and requires significant early investment for process development. This talk will provide perspectives on the key aspects of process development which impact long-term manufacturing success across the supply chain. These activities are critical for bulk and final product operations. Factors include selection of raw materials, evaluation of process parameter ranges, scale-up to production equipment and facility, analytical method robustness and support for validation and license preparation.
Sue Behrens, Ph.D., Independent Consultant; former Senior Director, Vaccines & Biologics, Merck Manufacturing Division
Vaccine manufacturing is complex and requires significant early investment for process development. This talk will provide perspectives on the key aspects of process development which impact long-term manufacturing success across the supply chain. These activities are critical for bulk and final product operations. Factors include selection of raw materials, evaluation of process parameter ranges, scale-up to production equipment and facility, analytical method robustness and support for validation and license preparation.
Sue Behrens, Ph.D., Independent Consultant; former Senior Director, Vaccines & Biologics, Merck Manufacturing Division
10:00
Networking Refreshment Break; Opening of Poster and Exhibit Hall
Vaccine Production in International Markets
10:45
Case
Study
Influenza Vaccine Manufacturing in Vietnam - Tech Transfer to New Production Facility, Start-Up, and OperationStudy
Under the 2006 Global Pandemic Influenza Action Plan to Increase Vaccine Supply, Vietnam's Institute of Vaccines and Medical Biologicals (IVAC) completed construction of a new manufacturing facility for egg-grown influenza vaccines with support from WHO. To complement this work, PATH is collaborating with BARDA to support IVAC on final developmental processes and advancement into the clinic. This presentation discusses the process, PATH's experiences with start-up and initial operation of the new facility, and challenges encountered.
Vadim Tsvetnitsky, Ph.D., Senior Technical Officer, Global Vaccine Development Program, PATH
11:15
Case
Study
Challenges of Legacy Product Technology Transfers Compounded by an International Receiving SiteStudy
Challenges associated with technology transfers of vaccine manufacturing processes are compounded when transferring a relatively old (>25 yrs) form/fill process to a green-field international site. Based on recent experience, this presentation highlights some potential roadblocks as well as best practices, including: knowledge gaps and mitigation; planning for international component sourcing; regulatory expectations and requirements; and, the importance of successful project governance.
Anthony W. Baker, Technical Product Leader, Merck Manufacturing Division, Merck
11:45
Case Study Sponsorship Opportunity Available
This session offers the opportunity for your company to present a sponsored presentation in this conference. Case studies, technology applications and end-user results are encouraged. For more information, please contact Kristen Schott at kschott@ibcusa.com or 508-614-1239.
This session offers the opportunity for your company to present a sponsored presentation in this conference. Case studies, technology applications and end-user results are encouraged. For more information, please contact Kristen Schott at kschott@ibcusa.com or 508-614-1239.
12:15
Networking Luncheon in Poster & Exhibit Hall
1:40
Chairperson's Opening Remarks
Norman W. Baylor, Ph.D., President & Chief Executive Officer, Biologics Consulting Group, Inc.; former Director, Office of Vaccines Research and Review (OVRR), US Food and Drug Administration
Norman W. Baylor, Ph.D., President & Chief Executive Officer, Biologics Consulting Group, Inc.; former Director, Office of Vaccines Research and Review (OVRR), US Food and Drug Administration
Process Development for Vaccines
1:45
Post Approval Process Changes and Challenges for Vaccines
This abstract was not available at the time of printing the brochure.
Siva Sakhamuri, Ph.D., Director, Manufacturing, Sanofi Pasteur Biologics
This abstract was not available at the time of printing the brochure.
Siva Sakhamuri, Ph.D., Director, Manufacturing, Sanofi Pasteur Biologics
2:15
Case
Study
Tech Transfer for Lyophilization Development from Laboratory to Manufacturing ScaleStudy
Development of a lyophilization cycle for a protein based vaccine using Quality by Design and design space principles will be presented in this case study. Also discussed will be considerations for scale-up and transfer to manufacturing scale, examples of surprising performance of industrial scale equipments and how to deal with them and how design space can be leveraged for site-to-site transfer activities.
Pierre Chouvenc, Ph.D., Deputy Director, Manufacturing Technology, Sanofi Aventis
2:45
Formulation and Process Impacts of Adjuvants
Adjuvant stability is an important consideration for vaccine development. In fact, adjuvant instability has been cited as a cause of reduced vaccine efficacy. Visible evidence of adjuvant instability is a criterion for discarding a vaccine product. The impacts of adjuvant stability on vaccine formulation and process development are the subject of this presentation. Both, traditional aluminum containing adjuvants and novel adjuvants will be discussed.
LaToya S. Jones Braun, Ph.D., Assistant Professor, Department of Pharmaceutical Sciences, University of Colorado School of Pharmacy
Adjuvant stability is an important consideration for vaccine development. In fact, adjuvant instability has been cited as a cause of reduced vaccine efficacy. Visible evidence of adjuvant instability is a criterion for discarding a vaccine product. The impacts of adjuvant stability on vaccine formulation and process development are the subject of this presentation. Both, traditional aluminum containing adjuvants and novel adjuvants will be discussed.
LaToya S. Jones Braun, Ph.D., Assistant Professor, Department of Pharmaceutical Sciences, University of Colorado School of Pharmacy
3:15
Networking Refreshment Break in Poster and Exhibit Hall
4:00
Case
Study
Plant-Based Gene Expression and Purification Processes to Manufacture Personalized Lymphoma Therapeutic VaccinesStudy
In recent years great strides have been made to establish a legitimate place for plant biotechnology in the spectrum of pharmaceutical manufacturing. Perhaps counter-intuitively, plant-based manufacturing can meet production speed and product delivery challenges better than conventional manufacturing platforms. The development and production of personalized, autologous therapeutic vaccines to treat follicular lymphoma will be presented as a case study to highlight the speed, flexibility and cost advantages plant-based technologies in a scenario where vaccines need to reach cancer patients as soon as possible after diagnosis.
Daniel Tusé, Ph.D., Managing Director, DT/Consulting Group
4:30
Case
Study
Myceliophthora Thermophila for the Production of VaccinesStudy
M. thermophila, is a linear-scaling, filamentous fungal expression system well-validated for the manufacture of industrial enzymes at 50-100g/L and on the 150,000L scale. The system is being adapted to human and animal biologics, with immediate attention towards vaccines due to a glycosylation profile 'nature-made' for vaccines. The unique biology of this fungus will be discussed with regard to its advantages at key stages of drug development (e.g., pre-clinical, DSP, etc.) and significant impact on cost-of-manufacturing.
Mark R. Alfenito, Ph.D., President & Chief Executive Officer, EnGen Bio, Inc.
5:00
Case
Study
Study
Global vaccine manufacturers have significantly increased their commitment to innovation. Established and next generation vaccines using recombinant technologies and a variety of host cells present new challenges in vaccine purification. In this workshop, we will present the advantages of hydroxyapatite chromatography in the purification strategy and practical considerations through the review of case studies.
Larry J. Cummings, Ph.D., Consulting Scientist, Process Chromatography, Bio-Rad Laboratories
5:30
Networking Cocktail Reception in Exhibit and Poster Hall
7:30
Networking Coffee
8:25
Chairperson's Opening Remarks
Ian Sellick, Director of Marketing, Pall Life Sciences
Ian Sellick, Director of Marketing, Pall Life Sciences
Using Single Use Components in Vaccine Production
Shared Session with Single-Use Applications Conference
Sponsored by:
Keynote Presentation
8:30
Single Use Process Components: Challenges and Opportunities for Manufacturing at Industrial ScaleFacilities for manufacturing of biopharmaceuticals or vaccines offer distinct advantages up to a certain scale if their design is based on single-use process components (with particular respect to the time needed for implementation as well as for handling and operating such systems in case of frequent product changeovers). The technological limitations of such systems with respect to process volumes, transfer or mixing of bulk volumes in the range of m³, handling aspects as well as storage and shipment of frozen product will be addressed.
Peter Kraemer, Ph.D., Head Engineering Process Development and Large Scale Fermentation, Sanofi SA, Germany
9:15
Case
Study
Pandemic Preparedness and the Manufacturing of an Emergency Vaccine - What Role Can Single-Use Systems Play?Study
The manufacturing process for FluBlok/PanBlok, a recombinant protein based influenza vaccine including the combination of single- and multi-use equipment in the current process will be described. Possible scenarios for establishing surge capacity range from warm base manufacturing facilities (ready to go when they need to), to facilities used for the production of other products that can be rapidly deployed when needed through a hybrid approach, to fully disposable factories. The speaker will evaluate advantages, and disadvantages of each scenario from a financial, regulatory, and engineering perspective.
Manon Cox, Ph.D., President & Chief Executive Officer, Protein Sciences Corporation
9:45
Networking Refreshment Break, Exhibit and Poster Viewing
10:30
Case
Study
International Tech Transfer and Start Up of a Pandemic Influenza Cell Culture Vaccine Manufacturing FacilityStudy
This abstract was not available at the time of printing the brochure.
Raghu Shivappa, Ph.D., Principal Scientist, Upstream Lead, Manufacturing Sciences and Technology, Novartis Vaccines and Diagnostics
11:00
Answering the Needs of the Animal Health Industry with Flexible Manufacturing Solutions
Veterinary medicine product development and manufacturing must have flexibility that is unique for a biologics manufacturing environment. Products must be delivered with a rapid return on investment, they must be delivered in a manner that allows for robust manufacturing, and COGS must be competitive. To meet these goals, product development is expedited by using disposable micro and mini bioreactors, robustness is being achieved by sound experimental design and COGS are competitive through the judicious use of larger scale disposable solutions. Several examples will be discussed.
Huw P. A. Hughes, Ph.D., Director, Laboratory Sciences Biological Development, Pfizer Animal Health
Veterinary medicine product development and manufacturing must have flexibility that is unique for a biologics manufacturing environment. Products must be delivered with a rapid return on investment, they must be delivered in a manner that allows for robust manufacturing, and COGS must be competitive. To meet these goals, product development is expedited by using disposable micro and mini bioreactors, robustness is being achieved by sound experimental design and COGS are competitive through the judicious use of larger scale disposable solutions. Several examples will be discussed.
Huw P. A. Hughes, Ph.D., Director, Laboratory Sciences Biological Development, Pfizer Animal Health
11:30
Several critical cell lines used for the production of viral products are anchorage dependent (CEF, VERO, MRC-5, WI-38 and A549). Scale-up of adherent cell culture to commercial scale is still an issue. Alternatively, usage of micro-carriers (e.g. Cytodex) is in principle scalable, however, bead-to-bead transfer is challenging. Other options for large scale adherent cell culture include hollow-fiber perfusion systems which in general are complicate to operate. Here we describe the evaluation of a fully scalable, disposable, fixed-bed bioreactor system (iCELLis™, ATMI) for virus/vaccine production. Data for production of a Paramyxovirus (VERO) and an Adenovirus (A549) are presented.
Kai S. Lipinski, Ph.D., Head of Cell Culture & Virus Production, Vibalogics GmbH, Germany
12:00
Networking Luncheon in Poster & Exhibit Hall
1:25
Chairperson's Opening Remarks
Jeffrey T. Blue, M.S., Senior Manager, Vaccine Drug Product Development and New Technologies, Merck Research Laboratories
Jeffrey T. Blue, M.S., Senior Manager, Vaccine Drug Product Development and New Technologies, Merck Research Laboratories
Formulation Issues in Vaccine Development
1:30
Vaccines as Well-Defined Pharmaceutical Dosage Forms: Challenges and Opportunities
Despite their macromolecular complexity and the presence of adjuvants, vaccines can potentially be developed as well-defined pharmaceutical dosage forms. The higher-order structural integrity and conformational stability of different vaccine antigens can be characterized by combining data sets from high-throughput biophysical methods as a function of solution conditions (temperature, pH, ionic strength) into empirical phase diagrams. Other considerations include antigen chemical stability, antigen interaction with adjuvants, and development of screening assays to identify stabilizing excipients.
David B. Volkin, Ph.D., Takeru and Aya Higuchi Distinguished Professor, Department of Pharmaceutical Chemistry, The University of Kansas
Despite their macromolecular complexity and the presence of adjuvants, vaccines can potentially be developed as well-defined pharmaceutical dosage forms. The higher-order structural integrity and conformational stability of different vaccine antigens can be characterized by combining data sets from high-throughput biophysical methods as a function of solution conditions (temperature, pH, ionic strength) into empirical phase diagrams. Other considerations include antigen chemical stability, antigen interaction with adjuvants, and development of screening assays to identify stabilizing excipients.
David B. Volkin, Ph.D., Takeru and Aya Higuchi Distinguished Professor, Department of Pharmaceutical Chemistry, The University of Kansas
2:00
Case
Study
Lessons Learned during Formulation Development for Live Virus VaccinesStudy
This presentation examines the complexities of formulation development for live virus vaccines. Case studies will illustrate the large impact that relatively minor excipient changes, both in the growth medium during the production process as well as in the drug product formulation, can have on virus stability in the final vaccine. Pitfalls to avoid when using biophysical methods or elevated temperatures to accelerate formulation screening will also be discussed.
Lynne A. Isopi, M.S., D.C., Senior Manager, Vaccine Drug Product and New Technologies, Merck
2:30
Case
Study
Application of Biophysical Characterization in Vaccine DevelopmentStudy
This abstract was not available at the time of printing the brochure.
Liuquan (Lucy) Chang, Ph.D., Principal Scientist, Pfizer Inc.
3:00
Networking Refreshment Break, Last Chance for Exhibit and Poster Viewing
3:30
Stabilizing Influenza Vaccines
The goal of this project is to identify a formulation that greatly improves influenza vaccine stability and is also amenable to adoption by vaccine manufacturers. Four formulation processes, including liquid and drying technologies, were applied to subunit influenza vaccines and stability was monitored under accelerated and real-time conditions. Results on lead formulations in terms of stability, immunogenicity, cost modeling, and regulatory approval pathway will be discussed.
Alex Flood, Ph.D., Program Officer, Technology Solutions, PATH
The goal of this project is to identify a formulation that greatly improves influenza vaccine stability and is also amenable to adoption by vaccine manufacturers. Four formulation processes, including liquid and drying technologies, were applied to subunit influenza vaccines and stability was monitored under accelerated and real-time conditions. Results on lead formulations in terms of stability, immunogenicity, cost modeling, and regulatory approval pathway will be discussed.
Alex Flood, Ph.D., Program Officer, Technology Solutions, PATH
4:00
Design of Solid-State Live Attenuated Influenza Virus Formulations for Enhanced Storage Stability
Solid-state formulations can impart improved thermal stability to biopharmaceuticals, relative to their liquid-state counterparts. In this study, stabilizing pharmaceutical formulations and three drying processes (freeze-, foam-, and spray-drying) were applied to live attenuated influenza virus, and stability was monitored under accelerated and real-time conditions. The impact of the drying process and formulation composition on LAIV storage stability will be discussed.
Jeff Anderl, Ph.D., Senior Manager, Research & Development, Aridis Pharmaceuticals
Solid-state formulations can impart improved thermal stability to biopharmaceuticals, relative to their liquid-state counterparts. In this study, stabilizing pharmaceutical formulations and three drying processes (freeze-, foam-, and spray-drying) were applied to live attenuated influenza virus, and stability was monitored under accelerated and real-time conditions. The impact of the drying process and formulation composition on LAIV storage stability will be discussed.
Jeff Anderl, Ph.D., Senior Manager, Research & Development, Aridis Pharmaceuticals
4:30
Stability and Formulation of Live-Attenuated Flavivirus Vaccines
This abstract was not available at the time of printing the brochure.
Jill Livengood, Ph.D., Scientist, InViragen, Inc.
This abstract was not available at the time of printing the brochure.
Jill Livengood, Ph.D., Scientist, InViragen, Inc.
5:00
Close of Sessions
8:00
Networking Coffee
8:25
Chairperson's Opening Remarks
Siva Sakhamuri, Ph.D., Director, Manufacturing, Sanofi Pasteur Biologics
Siva Sakhamuri, Ph.D., Director, Manufacturing, Sanofi Pasteur Biologics
The Application of Quality by Design Concepts in Vaccine Development
8:30
Case
Study
A-VAX—Quality by Design (QbD) Vaccine Case StudyStudy
In early 2010, PRTM (now PwC) partnered with PDA and five companies (GlaxoSmithKline, MedImmune, Merck, Pfizer, and Sanofi Pasteur) to develop a case study to illustrate how QbD could be applied to vaccine development and manufacturing. This working group built a series of examples demonstrating how key QbD enablers such as the use of prior knowledge, scale up studies, DOE experiments, and design space development could be used to make product development efforts more efficient, science based, and data driven. This presentation provides an overview of the Case Study and shares some of the challenges the group overcame as it worked to develop an approach and the rationale to show that QbD can in fact be applied to vaccines.
Jeffrey T. Blue, M.S., CMC-VWG Member, Senior Manager, Vaccine Drug Product Development and New Technologies, Merck Research Laboratories
9:00
Case
Study
Applying Quality by Design for a New Vaccine Development ProgramStudy
This abstract was not available at the time of printing the brochure.
Althaf I. Hussain, Ph.D., Principal Scientist, Vaccine Development, MedImmune
9:30
Applying Product and Process Understanding to Process Evolution during Clinical Development of a Conjugate Vaccine
The complexity of conjugate vaccines can lead to significant challenges during process development and scale up. Design of Experiment (DOE) has proven a powerful tool in understanding the conjugation process and establishing a process design space. This presentation will discuss the application of DOE in obtaining product and process understanding and its application to problem solving process development issues.
Tracy D. Scott, Principal Scientist, Conjugation and Polytide Process Development, Pfizer, Inc.
The complexity of conjugate vaccines can lead to significant challenges during process development and scale up. Design of Experiment (DOE) has proven a powerful tool in understanding the conjugation process and establishing a process design space. This presentation will discuss the application of DOE in obtaining product and process understanding and its application to problem solving process development issues.
Tracy D. Scott, Principal Scientist, Conjugation and Polytide Process Development, Pfizer, Inc.
10:00
Networking Refreshment Break
Characterization Studies in Support of Vaccine Production
10:30
Case
Study
Strategies for Developing, Validating, and Maintaining ELISA-Based Potency Assays for VaccinesStudy
Measuring potency is critical for ensuring vaccine product quality and manufacturing consistency. ELISA based potency assays are generally more robust and higher throughput than in vivo or ex vivo potency assays. There are numerous considerations for successful development ranging from reagent choice, reagent performance characteristics, and assay format. A case study will be provided that illustrates the importance of these considerations.
Marc Thorsteinsson, Ph.D., Research Fellow Vaccine Analytical Development, Merck and Co., Inc.
11:00
Case
Study
Characterization of Vaccines: Essential step in Developing Safe VaccinesStudy
Our focus is to develop effective vaccines against diseases caused by HIV, Influenza, Chikungunya, Ebola, Marburg and other viruses. Structural characterization is an essential step in determining the safety, and potency of vaccines. In addition, immunological characterization to determine the exposure of critical epitopes is required for determining the potency and efficacy of vaccines. Some of these assays may be used for the accelerated stability testing and forced degradation studies. We will present data on the characterization of CHIKV VLP and HIV vaccines.
Jonathan W. Cooper, Ph.D., Staff Scientist, Analytical Development, Vaccine Production Program Laboratory, Vaccine Research Center, NIAID, National Institutes of Health
11:30
Case
Study
Viral Gene Transfer Vector Product Characterization and Stability StudiesStudy
Recombinant viral vectors are increasingly being used in the clinic and new vectors that incorporate the latest science are being developed to target a wide array of diseases and tissues. As vector technology has improved, the safety and efficacy of viral-mediated gene transfer in animal models has been demonstrated, and sustained therapeutic benefit is being observed in human clinical trials. Aspects of viral vector product characterization, release testing, and stability studies will be presented.
Richard O. Snyder, Ph.D., Director of Biotherapeutic Programs, Office of Research, Associate Professor, Department of Molecular Genetics and Microbiology, University of Florida
12:00
Conference Concludes
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