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September 16-19, 2013 -
June 03-05, 2013
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Vaccine Development & Production Summit
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Agenda
7:30
Registration and Morning Coffee
8:30
Chairman's Opening Remarks
Michael A. Royals, DVM, Chief Science Officer and Head, Global Applications Development, PharmaJet, Inc.
Michael A. Royals, DVM, Chief Science Officer and Head, Global Applications Development, PharmaJet, Inc.
Keynote Presentation
8:45
What's Happening on the Vaccine Adjuvant Front?There have been several recent major developments in the vaccine adjuvant field, including FDA's recommendation for approval of squalene oil emulsions adjuvants for pandemic influenza vaccines. At the same time, the FDA is not recommending the new TLR9 adjuvant in Dynavax's hepatitis B vaccine on the basis of insufficient safety data. This talk explores these FDA responses and other recent events in the vaccine adjuvant arena, and provides insights from recent research into mechanisms of action of the major adjuvant categories.
Nikolai Petrovsky, Ph.D., Director, Endocrinology Department, Flinders Medical Center, Australia
Novel Adjuvants
9:15
TLR-Agonist and Non-TLR-Based Adjuvants for Infectious Disease Vaccines
This presentation shows the characterization of the immune stimulatory profiles of several unique TLR9 agonists in vitro in multiple cells types and in vivo in rhesus monkey immunogenicity studies with protein immunogens. The study also explores other TLR independent-adjuvant systems and their applications to infectious disease vaccines. Overviews on the use of various vaccines in humans and in non-human primates illustrates the potential for identifying new biomarkers for potency and safety for preclinical and clinical trials of antigens formulated with novel adjuvants.
Danilo Casimiro, Ph.D., Director, Vaccine Basic Research, Merck & Co.
This presentation shows the characterization of the immune stimulatory profiles of several unique TLR9 agonists in vitro in multiple cells types and in vivo in rhesus monkey immunogenicity studies with protein immunogens. The study also explores other TLR independent-adjuvant systems and their applications to infectious disease vaccines. Overviews on the use of various vaccines in humans and in non-human primates illustrates the potential for identifying new biomarkers for potency and safety for preclinical and clinical trials of antigens formulated with novel adjuvants.
Danilo Casimiro, Ph.D., Director, Vaccine Basic Research, Merck & Co.
9:45
The Next Generation of Vaccine Adjuvants
MF59 is a safe and effective adjuvant that has been licensed since 1997 and is now used in more than 30 countries. This presentation outlines details about its mechanism of action and how it was used as a guide to design a next generation of vaccine adjuvants, comprising an alum-based delivery component that adsorbs both antigen and a synthetic immune potentiator to activate the innate immune system through activation of TLR7.
Luis Brito, Ph.D., Head Formulation Science, Novartis Vaccines & Diagnostics
MF59 is a safe and effective adjuvant that has been licensed since 1997 and is now used in more than 30 countries. This presentation outlines details about its mechanism of action and how it was used as a guide to design a next generation of vaccine adjuvants, comprising an alum-based delivery component that adsorbs both antigen and a synthetic immune potentiator to activate the innate immune system through activation of TLR7.
Luis Brito, Ph.D., Head Formulation Science, Novartis Vaccines & Diagnostics
10:15
Networking Refreshment Break in Poster & Exhibit Hall
Sponsored by
Novel Vaccine Delivery
11:00
Needle-Free Flu Shots: Immunogenicity, Tolerability and Patient Acceptability of a Seasonal Influenza Vaccine Delivered with Jet Injectors
Abstract unavailable at press time.
Michael A. Royals, DVM, Chief Science Officer and Head, Global Applications Development, PharmaJet, Inc.
Abstract unavailable at press time.
Michael A. Royals, DVM, Chief Science Officer and Head, Global Applications Development, PharmaJet, Inc.
11:30
Oral Anti-CD3 mAb Vaccination/Immunotherapy: Proof of Principle in Humans
Abstract unavailable at press time.
Ronald Ellis, Ph.D., Senior Vice President, R&D and Chief Technology Officer, NasVax Ltd.
Abstract unavailable at press time.
Ronald Ellis, Ph.D., Senior Vice President, R&D and Chief Technology Officer, NasVax Ltd.
12:00
Simpler and More Efficient Vaccine Manufacturing: Move from Roller Bottles to the Integrity® iCELLis® Disposable Bioreactors.
Viral vaccines are usually produced in multitray systems, roller bottles or bioreactors with microcarriers. However, these technologies are not adapted to process intensification: they involve lots of manual operations and microcarriers require extensive development. The Integrity® iCELLis® disposable fixed-bed bioreactors (ATMI LifeSciences) are designed to simplify adherent cell processes, offering an efficient alternative to multitray systems, roller bottles or bioreactors with microbeads.
Jose Castillo, Global Director, Cell Culture Technologies, ATMI Life Sciences, Belgium
Viral vaccines are usually produced in multitray systems, roller bottles or bioreactors with microcarriers. However, these technologies are not adapted to process intensification: they involve lots of manual operations and microcarriers require extensive development. The Integrity® iCELLis® disposable fixed-bed bioreactors (ATMI LifeSciences) are designed to simplify adherent cell processes, offering an efficient alternative to multitray systems, roller bottles or bioreactors with microbeads.
Jose Castillo, Global Director, Cell Culture Technologies, ATMI Life Sciences, Belgium
12:30
Networking Luncheon in Poster & Exhibit Hall
1:55
Chairman's Opening Remarks
David B. Volkin, Ph.D., Distinguished Professor, Pharmaceutical Chemistry, University of Kansas
David B. Volkin, Ph.D., Distinguished Professor, Pharmaceutical Chemistry, University of Kansas
Keynote Presentation
2:00
Development of New Influenza Vaccines for Pandemic Preparedness and the FutureSince 2004, BARDA has supported the nation's pandemic preparedness and the technology use for seasonal and pandemic influenza vaccine production. This talk reviews the progress of the current BARDA programs and discusses future efforts to meet the nation's needs for seasonal and pandemic influenza vaccines.
Robert C. Huebner, Ph.D., Acting Director Influenza Division, HHS/ASPR/BARDA
Formulation and Characterization
2:30
Vaccines as Well-Defined Pharmaceutical Dosage Forms: Formulation and Analytical Challenges and Opportunities
This presentation examines the characterization, stabilization, and formulation of vaccines from the point of view of well-characterized pharmaceutical dosage forms. Some of the challenges encountered include the macromolecular complexity and conformational instability of vaccine antigens as well as the presence of adjuvants. Case studies illustrate (1) the utility of various biophysical methodologies to monitor the higher-order structural integrity, conformational stability, and aggregation propensity of different vaccine antigens, and (2) the importance of antigen structural integrity and antigen-adjuvant interactions to the optimization of immune responses.
David Volkin, Ph.D., Distinguished Professor, Pharmaceutical Chemistry, University of Kansas
This presentation examines the characterization, stabilization, and formulation of vaccines from the point of view of well-characterized pharmaceutical dosage forms. Some of the challenges encountered include the macromolecular complexity and conformational instability of vaccine antigens as well as the presence of adjuvants. Case studies illustrate (1) the utility of various biophysical methodologies to monitor the higher-order structural integrity, conformational stability, and aggregation propensity of different vaccine antigens, and (2) the importance of antigen structural integrity and antigen-adjuvant interactions to the optimization of immune responses.
David Volkin, Ph.D., Distinguished Professor, Pharmaceutical Chemistry, University of Kansas
3:00
Technology Workshop Opportunity
This technology highlight session is available. For more information contact Kristen Schott at (508) 614-1239 or kschott@ibcusa.com, or Ellen Moorehead at (508) 614-1406 or emoorehead@ibcusa.com.
This technology highlight session is available. For more information contact Kristen Schott at (508) 614-1239 or kschott@ibcusa.com, or Ellen Moorehead at (508) 614-1406 or emoorehead@ibcusa.com.
3:30
Networking Refreshment Break in Poster & Exhibit Hall
Sponsored by
4:15
Vaccine Formulation Update
Abstract unavailable at press time.
Dominique Lemoine, Director, Head of Formulation, Filling & Lyophilization, VDD, New Product Development, GlaxoSmithKline Vaccines, Belgium
Abstract unavailable at press time.
Dominique Lemoine, Director, Head of Formulation, Filling & Lyophilization, VDD, New Product Development, GlaxoSmithKline Vaccines, Belgium
4:45
NanoStat™ Platform for Mucosal Vaccine Delivery and Adjuvant: A Unique Technology Suited to Enable Vaccines Against Respiratory and Sexually Transmitted Diseases
This presentation examines the NanoStat™ technology, a high-energy, positively-charged oil in water nanoemulsion (NE) that is capable of formulating and adjuvanting antigens for mucosal vaccination to enhance not only mucosal, but also systemic immunogenicity. The talk also demonstrates a balanced Th1/Th2/and Th17 immune response when recombinant proteins, peptides, as well as whole virus antigens were evaluated. Additionally, the utility of these immune attributes with vaccines against respiratory and sexually transmitted diseases is addressed.
Ali Fattom, Ph.D., Senior Vice President, R&D, NanoBio Corporation
This presentation examines the NanoStat™ technology, a high-energy, positively-charged oil in water nanoemulsion (NE) that is capable of formulating and adjuvanting antigens for mucosal vaccination to enhance not only mucosal, but also systemic immunogenicity. The talk also demonstrates a balanced Th1/Th2/and Th17 immune response when recombinant proteins, peptides, as well as whole virus antigens were evaluated. Additionally, the utility of these immune attributes with vaccines against respiratory and sexually transmitted diseases is addressed.
Ali Fattom, Ph.D., Senior Vice President, R&D, NanoBio Corporation
Keynote Presentation
5:15
Flublok®: Developing the World's First Recombinant, Highly Purified, Egg-Free Influenza VaccineThis presentation explores the novel manufacturing technology and regulatory pathway of Flublok, which the FDA regards as a technological advance in the manufacturing of an influenza vaccine. This keynote examines the departure from using the virus and eggs in production and how the process allows for the rapid production of large quantities of the influenza virus protein, hemagglutinin (HA), using a baculovirus expression system.
Manon M.J. Cox, President and CEO, Protein Sciences Corporation
5:45
Wine & Cheese Reception in Poster & Exhibit Hall
7:30
Morning Coffee
8:00
Chairman's Opening Remarks
Robert Repetto, M.S., MBA, Research Fellow, External Affairs, Pfizer, Inc.
Robert Repetto, M.S., MBA, Research Fellow, External Affairs, Pfizer, Inc.
Keynote Presentation
8:15
Current Prospects and Future Outlook for Cell Culture-Based Vaccine ProductionThe year 2012 was a remarkable time in the history of vaccination. It ushered an FDA-approved influenza vaccine produced in cell culture and a U.S. facility to manufacture it. While production of influenza vaccines in eggs has served the industry well, the method is showing signs of aging and limitations. This presentation explores industry's ability to respond rapidly to pandemics, to better cover clinically-relevant and genetically-different strains by using cell culture and modern tools to generate vaccine seeds using synthetic biology.
Rino Rappuoli, Ph.D., Global Head, Vaccines Research, Novartis Vaccines & Diagnostics, Italy
Process Development and Manufacturing Challenges
9:00
Cost & Quality Considerations in Plant-Based Production Systems
Abstract unavailable at press time.
Stephan Hellwig, Project Manager, Fraunhofer Institute for Molecular Biology and Applied Ecology, Germany
Abstract unavailable at press time.
Stephan Hellwig, Project Manager, Fraunhofer Institute for Molecular Biology and Applied Ecology, Germany
9:30
Case
Study
Continuous Improvement in Downstream Purification ProcessStudy
Continuous improvement in a downstream purification process for recombinant proteins to be used as vaccine candidates is an integral part of process development. This case study discusses the adjustment of the purification process to keep consistent product purity and quality.
Davinder Chawla, Senior Development Scientist, Downstream Purification Process Development, Sanofi Pasteur, Canada
10:15
Networking Refreshment Break in Poster & Exhibit Hall
Sponsored by
10:45
Purification of Virus-Like Particle Vaccine
Novavax, Inc., a clinical-stage biopharmaceutical company, creates a variety of proprietary recombinant nanoparticle vaccines, including virus-like particles (or VLPs) and recombinant protein micelles. Its nanoparticle vaccines are produced using baculovirus infected insect cell culture, and this presentation explores the purification effort, including disposable technology used in manufacturing Novavax nanoparticle vaccines.
Hua Jiang, Ph.D., Director, Downstream Purification, Novavax, Inc.
Novavax, Inc., a clinical-stage biopharmaceutical company, creates a variety of proprietary recombinant nanoparticle vaccines, including virus-like particles (or VLPs) and recombinant protein micelles. Its nanoparticle vaccines are produced using baculovirus infected insect cell culture, and this presentation explores the purification effort, including disposable technology used in manufacturing Novavax nanoparticle vaccines.
Hua Jiang, Ph.D., Director, Downstream Purification, Novavax, Inc.
11:15
Case
Study
Case Studies Demonstrating a Single Step Purification of Virus ParticlesStudy
Ceramic hydroxyapatite (CHT) was used to purify dengue virus type 2. The infectious activity was retained after loading culture fluid onto the CHT column and eluting retained components with a linear sodium phosphate gradient. Culture fluid and protein contaminants elute early in the phosphate gradient followed by dsDNA then dengue virus. The purification process was simple and rapid and provided product with 64% retained infectious activity. The method appears highly reproducible and the presentation includes case studies for the purification of influenza virus, Japanese encephalitis virus and adenovirus.
Yea Kurosawa, PENTAX New Ceramics Division, Hoya Corporation
Larry Cummings, Consulting Scientist, Process Chromatography, Bio-Rad Laboratories
QbD and Process Validation
11:45
Case
Study
Deciding when to apply QbD Principles for VaccinesStudy
Deciding when and how to deploy QbD principals in process development often requires a balanced consideration of time, cost, resources and returned value. There is always another experiment that could be done. Using a value stream approach, an evaluation strategy is presented which can help discussions concerning QbD implementation. A cross company working group was formed to investigate how QbD might be applied to a vaccine. A case study titled A-VAX Applying Quality by Design to Vaccines was developed by the CMC Vaccine Working Group in 2012 and is presented.
Robert Repetto, M.S., MBA, Research Fellow, External Affairs, Pfizer, Inc.
12:15
The Possibility of Continuous Bioproduction in Single-Use System Based Vaccine Manufacturing
Single-use systems support vaccine production in such cells as Vero, MDCK, PER.C6 and many insect cells. Both anchorage -independent and -dependant, cell substrates can be used to express proteins which efficiently self-assemble into virus-like particles (eg, HA, NA, M1), or can be incorporated into nanoparticles (micelles). Such suspension and adherent cultures are also used to support constitutively expressed rProtein-based, or experimental non-lytic, persistent infection based vaccine platforms. Continuous bioprocessing (CB) offers such advantages as heightened processing consistency, yielding improved product uniformity and reduced process intermediates intervention. It also provides advantages in facility design and build through reduced footprint and increased facility utilization. It's online monitoring and real-time quality assurance support makes it amenable to CQV and parametric or real-time release initiatives. By far the most common approach to upstream CB is perfusion culture. A number of SU reactor styles exist for anchorage-dependent cell vaccine platforms, such as multiple or stacked surface, microfiber / hydrogel scaffold, microcarriers, and hollow fiber bioreactors. A number of reactor styles exist for such anchorage-independent (suspension) platforms as baculovirus infections or rMammalian cells expressing antigenic proteins. Some of these reactors can support CB based production, including both classical and single-use bioreactors employing perfusion implementations.
William Whitford, Senior Technical Market Manager, Thermo Scientific Cell Culture & BioProcessing, Thermo Fisher Scientific
Single-use systems support vaccine production in such cells as Vero, MDCK, PER.C6 and many insect cells. Both anchorage -independent and -dependant, cell substrates can be used to express proteins which efficiently self-assemble into virus-like particles (eg, HA, NA, M1), or can be incorporated into nanoparticles (micelles). Such suspension and adherent cultures are also used to support constitutively expressed rProtein-based, or experimental non-lytic, persistent infection based vaccine platforms. Continuous bioprocessing (CB) offers such advantages as heightened processing consistency, yielding improved product uniformity and reduced process intermediates intervention. It also provides advantages in facility design and build through reduced footprint and increased facility utilization. It's online monitoring and real-time quality assurance support makes it amenable to CQV and parametric or real-time release initiatives. By far the most common approach to upstream CB is perfusion culture. A number of SU reactor styles exist for anchorage-dependent cell vaccine platforms, such as multiple or stacked surface, microfiber / hydrogel scaffold, microcarriers, and hollow fiber bioreactors. A number of reactor styles exist for such anchorage-independent (suspension) platforms as baculovirus infections or rMammalian cells expressing antigenic proteins. Some of these reactors can support CB based production, including both classical and single-use bioreactors employing perfusion implementations.
William Whitford, Senior Technical Market Manager, Thermo Scientific Cell Culture & BioProcessing, Thermo Fisher Scientific
12:45
Networking Luncheon in Poster & Exhibit Hall
Single-Use Applications in Vaccine Production Shared Session with IBC's Single-Use Applications for Biopharmaceutical Manufacturing
Session Sponsor:
1:50
Chairman's Opening Remarks
Ian Sellick, Director of Marketing, Pall Life Sciences
Ian Sellick, Director of Marketing, Pall Life Sciences
Featured Presentation
2:00
Case
Study
Implementation of SU Technology for Production of UK Anthrax VaccineStudy
The UK-licensed anthrax vaccine, Anthrax Vaccine Precipitated (AVP), has been produced using the same process for a number of years. We are evaluating the application of single-use technology to modernize the process. Data is presented to assess the comparability of AVP produced using modernized compared to traditional methods, in terms of both vaccine composition and immunogenicity.
Kelly Lowings, Ph.D., Senior Scientist, Vaccine Research Group, Public Health England, United Kingdom
2:30
Vaccine Manufacturing Technologies Suitable for New Manufacturers in Emerging Markets
Vaccine manufacturers in emerging markets are traditionally producing high-volume, low-cost vaccines. Often, small countries in emerging markets aspire to manufacture vaccines internally and attain self-sufficiency. This presentation explores the cost and time efficient technologies required to produce multiple products. It also covers flexible manufacturing platforms and solutions that comprehensively address cost-effective requirements. The talk also covers how the combination of modular vaccine manufacturing facilities, high throughput processes and disposable technologies can redefine the way vaccines are manufactured.
Sreenivasa Reddy Guddeti, B.V.Sc., Chief General Manager, Indian Immunologicals Limited, India
Vaccine manufacturers in emerging markets are traditionally producing high-volume, low-cost vaccines. Often, small countries in emerging markets aspire to manufacture vaccines internally and attain self-sufficiency. This presentation explores the cost and time efficient technologies required to produce multiple products. It also covers flexible manufacturing platforms and solutions that comprehensively address cost-effective requirements. The talk also covers how the combination of modular vaccine manufacturing facilities, high throughput processes and disposable technologies can redefine the way vaccines are manufactured.
Sreenivasa Reddy Guddeti, B.V.Sc., Chief General Manager, Indian Immunologicals Limited, India
3:00
Recombinant Protein Vaccines Produced in Insect Cells
The baculovirus-insect cell expression system is used in the manufacturing of various vaccines. The key advantage of this recombinant protein manufacturing platform is its universal "plug and play" process for the production of a broad range of protein-based products. This presentation explores this production platform and provides an overview of products that it yields.
Valerie Mermall, Ph.D., Director, Quality Control, Protein Sciences Corporation
The baculovirus-insect cell expression system is used in the manufacturing of various vaccines. The key advantage of this recombinant protein manufacturing platform is its universal "plug and play" process for the production of a broad range of protein-based products. This presentation explores this production platform and provides an overview of products that it yields.
Valerie Mermall, Ph.D., Director, Quality Control, Protein Sciences Corporation
3:30
Networking Refreshment Break in Poster & Exhibit Hall
Sponsored by
4:00
Design and Deployment Strategy for Single-Use Component Assemblies
Single-use technologies can help reduce manufacturing costs, improve start-up times, and facilitate the introduction of vaccines to new markets. These benefits are lost if certain practical considerations are not addressed during process design. Connectivity of unit operations, standardization of parts, and simplification of inventories are all keys to success with single-use technology. This talk presents general principles for single-use system design for upstream, downstream, or filling operations in sterile pharmaceutical, vaccine, and biologics manufacturing.
Mark A. Petrich, Associate Director, Component Engineering, Merck & Co.
Single-use technologies can help reduce manufacturing costs, improve start-up times, and facilitate the introduction of vaccines to new markets. These benefits are lost if certain practical considerations are not addressed during process design. Connectivity of unit operations, standardization of parts, and simplification of inventories are all keys to success with single-use technology. This talk presents general principles for single-use system design for upstream, downstream, or filling operations in sterile pharmaceutical, vaccine, and biologics manufacturing.
Mark A. Petrich, Associate Director, Component Engineering, Merck & Co.
Technology Rapid-Fire Showcase
4:30
Plug and play single-use filtration solutions deliver processing convenience for biopharmaceutical manufacturers. Innovative filtration media and multi-stage filtration train designs provide truly scalable performance from PD to production. Unique, integrated sensor connectivity supports process monitoring functionality while associated support products provide for robust, repeatable, deployment of large scale filtration solutions.
Max Blomberg, Director of Operations, Meissner Filtration Products
4:50
Multi-Process Control Systems: Leveraging True Flexibility in Single-Use
Ian Sellick, Director of Marketing, Pall Life Sciences
Ian Sellick, Director of Marketing, Pall Life Sciences
5:10
Close of Day Two; Poster & Exhibit Hall Closes
Site Tour
5:15
FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
Fujifilm Diosynth Biotechnologies, a full-service Biologics Contract Development and Manufacturing Organization in Morrisville, North Carolina, invites you to tour its recently expanded Single-Use manufacturing facility in Research Triangle Park, NC! Along with its Billingham, UK, facility, these sites offer more than 25 years of combined experience in the development and manufacture of recombinant proteins, vaccines and monoclonal antibodies, expressed in a wide array of microbial, mammalian and insect cell systems. Transportation is provided, but space is limited and available on a first-come, first-served basis. There is no additional fee, but pre-registration is required.
Fujifilm Diosynth Biotechnologies, a full-service Biologics Contract Development and Manufacturing Organization in Morrisville, North Carolina, invites you to tour its recently expanded Single-Use manufacturing facility in Research Triangle Park, NC! Along with its Billingham, UK, facility, these sites offer more than 25 years of combined experience in the development and manufacture of recombinant proteins, vaccines and monoclonal antibodies, expressed in a wide array of microbial, mammalian and insect cell systems. Transportation is provided, but space is limited and available on a first-come, first-served basis. There is no additional fee, but pre-registration is required.
8:00
Morning Coffee
8:30
Chairman's Opening Remarks
Kevin P. Killeen, Ph.D., Chief Scientific Officer, Matrivax Research and Development Corp.
Kevin P. Killeen, Ph.D., Chief Scientific Officer, Matrivax Research and Development Corp.
New Vaccine Research
8:45
Advances in Single Use System Design for Vaccine Development, Scale-up and Production
This presentation will provide an overview of Single Use fluid management technology and how advances in single use system design can speed up the development of vaccine manufacturing processes by providing modular and scalable manufacturing systems.
Chris Shields, Market Manager, Single Use Systems, Saint-Gobain Life Science
This presentation will provide an overview of Single Use fluid management technology and how advances in single use system design can speed up the development of vaccine manufacturing processes by providing modular and scalable manufacturing systems.
Chris Shields, Market Manager, Single Use Systems, Saint-Gobain Life Science
9:15
Case
Study
Flunisyn: A Synthetic, Easily Characterized Pan Influenza A Vaccine (Seasonal and Pandemic) with Potential of Mass Production for Global Population CoverageStudy
Flunisyn is a stable, synthetic, self-adjuvanting vaccine with the potential to target all pandemic and seasonal influenza A strains. It is a freeze-dried vaccine formulation comprised of six different synthetic long peptides, each conjugated to a fluorocarbon moiety. Vaccine peptides are identified using a proprietary bioinformatics approach optimized to select sequences based on three important criteria 1) high degree of conservation 2) high immunogenicity, and 3) manufacturability towards large scale.
Bertrand Georges, Ph.D., Chief Technical Officer and Co-Founder, Immune Targeting Systems, United Kingdom
9:45
Development of Protein Capsular Matrix Vaccine (PCMV) Technology
Matrivax R&D Corp. is a start-up biotechnology company with R&D operations in Boston, MA, and a GMP vaccine pilot facility in Haikou, China. This presentation discusses Matrivax's development of its Protein Capsular Matrix Vaccine (PCMV), a proprietary vaccine process that entraps polysaccharides in a cross-linked protein "carrier" or matrix. Matrivax is researching and developing pneumococcal and enteric fever (Typhoid) PCMV candidates. Additional discussions explore preclinical data, GMP manufacture and Phase 1 trial plans.
Kevin P. Killeen, Ph.D., Chief Scientific Officer, Matrivax Research and Development Corporation
Matrivax R&D Corp. is a start-up biotechnology company with R&D operations in Boston, MA, and a GMP vaccine pilot facility in Haikou, China. This presentation discusses Matrivax's development of its Protein Capsular Matrix Vaccine (PCMV), a proprietary vaccine process that entraps polysaccharides in a cross-linked protein "carrier" or matrix. Matrivax is researching and developing pneumococcal and enteric fever (Typhoid) PCMV candidates. Additional discussions explore preclinical data, GMP manufacture and Phase 1 trial plans.
Kevin P. Killeen, Ph.D., Chief Scientific Officer, Matrivax Research and Development Corporation
10:15
Networking Refreshment Break
10:45
mRNA-based Vaccines: Platform Technology for Immunization
CureVac uses an expression optimized, self-adjuvanted mRNA version, "RNActive," to express protein antigens and induce powerful immune responses. RNActive-induced immune responses are balanced, comprising humoral and cellular, effector and memory responses. Protection has been demonstrated in a variety of demanding viral challenge models. Safety and immunogenicity in humans are already established in oncology studies and a Phase I study for prophylactic vaccines is prepared.
Karl-Josef Kallen, Principal Scientific Fellow, CureVac GmbH, Germany
CureVac uses an expression optimized, self-adjuvanted mRNA version, "RNActive," to express protein antigens and induce powerful immune responses. RNActive-induced immune responses are balanced, comprising humoral and cellular, effector and memory responses. Protection has been demonstrated in a variety of demanding viral challenge models. Safety and immunogenicity in humans are already established in oncology studies and a Phase I study for prophylactic vaccines is prepared.
Karl-Josef Kallen, Principal Scientific Fellow, CureVac GmbH, Germany
11:15
Multi-Component Multivalent Vaccines, Challenges and Bright Areas
To improve compliance with vaccination recommendations, more multivalent vaccines must be considered. This presentation explores how this type of vaccination strategy would significantly impact public opinion when people are asked to receive several vaccines as separate doses or in separate healthcare visits within a year, versus the alternative with multivalent vaccines. The production side of vaccines can also benefit from combining several products into multivalent doses as well, in which case there are fewer unit productions.
Ben Locwin, Ph.D., Head of Training & Development, Quality Assurance, Lonza Biopharmaceuticals
To improve compliance with vaccination recommendations, more multivalent vaccines must be considered. This presentation explores how this type of vaccination strategy would significantly impact public opinion when people are asked to receive several vaccines as separate doses or in separate healthcare visits within a year, versus the alternative with multivalent vaccines. The production side of vaccines can also benefit from combining several products into multivalent doses as well, in which case there are fewer unit productions.
Ben Locwin, Ph.D., Head of Training & Development, Quality Assurance, Lonza Biopharmaceuticals
11:45
Close of Conference
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