IBC Life Sciences
The leading provider of scientific, technological and business information
Main menu
My IBC
Vaccine Production Summit
CSS
Event Information
Document Title
Agenda
Implementing the New Process Validation Guidelines and New Technologies for Vaccine Production
A new Process Validation Guideline by FDA has been published as a draft, providing the agency's current thinking with regard to process validation. The Guidance document intends to promote modern manufacturing principles, process improvement, innovation, and sound science.
Process validation is now viewed as a product lifecycle activity; from early development to the end of commercial production, and it is viewed as three stages: 1) Process Design; 2) Process Qualification; and 3) Continued Process Verification. This workshop will discuss each stage of process validation, the new directions highlighted in the Guidance and new technologies and innovations to promote modern development and manufacturing principles.
A particular focus of the workshop will be how the new Guidance and technologies can speed time to market and improve operational excellence for companies of all sizes. If the final Guidance is released between the publication of this program and the event, the key differences between the draft and final versions will be described.
Workshop Schedule:
7:45
Registration and Networking Coffee
8:10
Presentation: The New FDA Process Validation Guidance
E.J. Brandreth, Ph.D., Vice President, Quality and Regulatory Affairs, Althea Technologies
E.J. Brandreth, Ph.D., Vice President, Quality and Regulatory Affairs, Althea Technologies
9:00
Discussion and Breakout Sessions: New Process Validation Guidance and How the New Guidance can be Used to Speed Development and Improve Quality
Sara Terpening, Ph.D., Director, Manufacturing, Testing and Technical Services, DynPort Vaccine Company LLC
Sara Terpening, Ph.D., Director, Manufacturing, Testing and Technical Services, DynPort Vaccine Company LLC
9:30
Networking Refreshment Break
10:00
Presentation: New Vaccine Production Technologies and Innovation
James Blackwell, Ph.D., M.B.A., Senior Consultant, BioProcess Technology Consultants, Inc.
James Blackwell, Ph.D., M.B.A., Senior Consultant, BioProcess Technology Consultants, Inc.
11:10
Discussion and Breakout Sessions: Implementing New Technologies to Speed Time to Market and Reduce Development and Manufacturing Costs
11:45
Workshop Ends; Lunch on Your Own
Workshop: Monday | Main Conference: Monday | Tuesday | Wednesday
1:10
Chairperson's Opening Remarks
Alex Tracy, Ph.D., Head, Global Manufacturing Technology Development, Novartis Vaccines and Diagnostics
Alex Tracy, Ph.D., Head, Global Manufacturing Technology Development, Novartis Vaccines and Diagnostics
Keynote Presentation
1:15
Improving Interactions Between the FDA, Regulated Industry, and AcademiaGaining FDA approval of clinical trials is widely viewed as a "choke point" in product development. Fueling this problem are differences in the culture and goals of regulated industry, academia, and the FDA. This lecture will discuss the nature of these differences, and approaches to reducing their impact.
Dennis M. Klinman, M.D., Ph.D., Senior Investigator, Head, Immune Modulation Group, Laboratory of Experimental Immunology, National Cancer Institute
Next Generation Expression Systems for Increased Yield and Quality
2:00
Case
Study
Scale-Up of Transient Plant-Based Expression SystemStudy
With the number of doses and quick delivery to market being critical factors in influenza vaccine production, Medicago has developed a high yielding expression system using transient plant-based expression that allows production to start within days after the strain genetic sequence is known. Simple purification steps have delivered a pure product, meeting the needed quality, safety, efficacy and stability expected from regulatory agencies and tested in phase I clinical studies.
Brigitte Barbeau, Ph.D., Vice President, Manufacturing, Medicago
2:30
Case
Study
Insect Cell-Based Vaccines: Rapid Response to Seasonal and Pandemic InfluenzaStudy
The Baculovirus Expression Vector System (BEVS) is emerging as a robust insect cell-based manufacturing vaccine technology. Critical advantages provided by this platform include the ability to produce complex antigens against potential pandemic pathogens (i.e. influenza hemagglutinin protein) in a rapid, safe and effective manner. This presentation will provide an overview of the technology and how it is being applied to commercialize recombinant hemagglutinin-based influenza vaccines as a case study example.
Joseph A. Rininger, Ph.D., Senior Director, Influenza, Protein Sciences Corporation
3:00
Caulobacter crescentus: A New Expression and Display System for Vaccines and Immune Therapeutics
Secretion of recombinant proteins for vaccines or other applications enables lower downstream processing costs. For proteins that cannot be exported via the typical Sec-dependent pathway, bacterial Type I secretion offers an alternative. Display of vaccine, therapeutic or infection-blocking agents on bacteria is a means of producing low cost agents but high-density display is often not possible. Caulobacter crescentus assembles a two-dimensional crystalline surface "S-layer" composed of a highly expressed Type I secreted protein. With it one can secrete or display a wide variety of proteins for vaccine applications.
John Smit, Ph.D., Professor, Microbiology and Immunology, University of British Columbia, Canada
Secretion of recombinant proteins for vaccines or other applications enables lower downstream processing costs. For proteins that cannot be exported via the typical Sec-dependent pathway, bacterial Type I secretion offers an alternative. Display of vaccine, therapeutic or infection-blocking agents on bacteria is a means of producing low cost agents but high-density display is often not possible. Caulobacter crescentus assembles a two-dimensional crystalline surface "S-layer" composed of a highly expressed Type I secreted protein. With it one can secrete or display a wide variety of proteins for vaccine applications.
John Smit, Ph.D., Professor, Microbiology and Immunology, University of British Columbia, Canada
3:30
Grand Opening of Poster and Exhibit Hall with Networking Refreshment Break
Novel Vaccine Purification Methods
4:00
Case
Study
Intensification of an Adenovirus ProcessStudy
To meet manufacturing demand a process intensification project was initiated. Virus titers were increased 10-20 fold at the expense of higher impurities levels. As a result the harvest process (lysis, precipitation and clarification) needed to be redesigned. HC-DNA was selectively precipitated in the intensified harvest. Low impurity levels were observed after clarification, allowing the omission of one DSP step. This resulted in a purification process of one anion exchange chromatography capsule followed by a formulation step.
Marloes Veenstra, Ph.D., Scientist, Downstream Process Development, Crucell, The Netherlands
4:30
Case
Study
Ensuring the Purity of a Live Attenuated Influenza Vaccine ProductStudy
FluMist® is licensed in the U.S., S. Korea, Hong Kong and Israel, and it is currently manufactured in specific pathogen-free embryonated chicken eggs. To increase the quantity and reliability of the nation's influenza vaccine supply for seasonal epidemic as as well as pandemic preparedness, MedImmune has developed a cell culture-based production system for the vaccine. The developed process, based on established cell culture bioreactor technology and the optimization of the purification process for seasonal and pandemic influenza vaccine production, will be presented.
Mark W. Thompson, RPh, Ph.D., Director, Vaccine Development, MedImmune, Inc.
5:00
Technology Workshop
IBC's Technology Workshops offer supplier and service companies the opportunity to present product and service offers directly to the audience at the conference. For further information on sponsoring a Technology Workshop, please contact Kristen Schott; 508-614-1239; kschott@ibcusa.com
IBC's Technology Workshops offer supplier and service companies the opportunity to present product and service offers directly to the audience at the conference. For further information on sponsoring a Technology Workshop, please contact Kristen Schott; 508-614-1239; kschott@ibcusa.com
5:30
Networking in Poster and Exhibit Hall
Workshop: Monday | Main Conference: Monday | Tuesday | Wednesday
7:30
Networking Coffee
7:55
Chairperson's Opening Remarks
James Blackwell, Ph.D., M.B.A., Senior Consultant, BioProcess Technology Consultants, Inc.
James Blackwell, Ph.D., M.B.A., Senior Consultant, BioProcess Technology Consultants, Inc.
Keynote Presentation
8:00
Bringing Vaccine Manufacturing Capabilities to the Developing WorldThe mission of the PATH Vaccine Development Global Program is to improve the health of populations living in low-income countries, by accelerating development of vaccines that will be effective and affordable in the countries that most urgently need them. Our efforts include domestic development and distribution of new vaccines in low-income countries. This presentation will discuss the successes, challenges, and opportunities we have encountered in the program.
George A. Robertson, Ph.D., Senior Technical Advisor, Vaccine Development Global Program, PATH
Special Presentation
8:45
Application of DARPA Accelerated Manufacture of Pharmaceuticals (AMP) Program
Abstract unavailable at press date.
Michael V. Callahan, M.D., DTM&H, Command Physician, Defense Science Office (DSO), Defense Advanced Research Projects Agency (DARPA)
Abstract unavailable at press date.
Michael V. Callahan, M.D., DTM&H, Command Physician, Defense Science Office (DSO), Defense Advanced Research Projects Agency (DARPA)
Process Development for New Classes of Immunotherapies
9:15
Increase of Vaccine Production Capacity without Vast Investments by Using Novel Purification Platforms
The application of chromatography represents an increasing trend in the field of virus purification. This work focuses on the unique constraints imposed by virus particles and how they relate to the strengths and limitations of various purification techniques. It will be shown that the yield of production processes can easily be doubled replacing centrifugation by chromatography using novel media, resulting in better availability of vaccines without large investments in building and equipment for new facilities.
Aleš Štrancar, Ph.D., Chief Executive Officer, BIA Separations, Austria
The application of chromatography represents an increasing trend in the field of virus purification. This work focuses on the unique constraints imposed by virus particles and how they relate to the strengths and limitations of various purification techniques. It will be shown that the yield of production processes can easily be doubled replacing centrifugation by chromatography using novel media, resulting in better availability of vaccines without large investments in building and equipment for new facilities.
Aleš Štrancar, Ph.D., Chief Executive Officer, BIA Separations, Austria
9:45
Case
Study
Progress Toward a Synthetic Glycoconjugate Vaccine for Clinical Malaria: Practical Synthesis of the GPI Carbohydrate AntigenStudy
Carbohydrate antigen production is accomplished primarily through fermentation and isolation processes that often result in mixtures and ill-defined material. Inadequate access to high quality, defined carbohydrate antigens limits broader application of glycoconjugate vaccines. Ancora has developed scalable, reproducible chemical syntheses to high-quality complex carbohydrates to support vaccine discovery, development and commercialization. This case study highlights Ancora's unique anti-malaria GPI-based vaccine approach, demonstrating that synthetic carbohydrate vaccines are commercially feasible.
A. Stewart Campbell, Ph.D., Vice President, Research & Development, Ancora Pharmaceuticals, Inc.
10:15
Networking Refreshment Break, Exhibit and Poster Viewing
11:00
Case
Study
Preclinical Development and Scale-Up for Advaxis Listeria Cancer VaccineStudy
This presentation will explain how single use technologies have been applied to the development of a manufacturing platform for Advaxis's novel live whole cell listeria cancer vaccine. Included are the adaptation of an existing the manufacturing process to the restrictions of single use technologies, design and the development of the manufacturing assemblies, systems validation and the production of clinical materials.
Tony Hitchcock, Head of Manufacturing Technologies, Cobra Biomanufacturing Plc, United Kingdom
11:30
Case
Study
Characterization of Meningitis B Vaccine Containing 3 Recombinant Proteins and Outer Membrane Vesicles (OMV) from Neisseria MeningitidesStudy
This case study describes the characterization steps for a novel vaccine containing three recombinant proteins and outer membrane vesicles (OMVs) from Neisseria meningitides. This complex combination is difficult to characterize, and the presentation outlines the comparability approach taken, regulatory perspectives, methods to approach antigen peculiarities, and the relationships between the results of different analytical methods used.
Claudia Magagnoli, Ph.D., Analytical Project Manager, Technology Development, Novartis Vaccines, Italy
12:00
Technology Workshop
IBC's Technology Workshops offer supplier and service companies the opportunity to present product and service offers directly to the audience at the conference. For further information on sponsoring a Technology Workshop, please contact Kristen Schott; 508-614-1239; kschott@ibcusa.com
IBC's Technology Workshops offer supplier and service companies the opportunity to present product and service offers directly to the audience at the conference. For further information on sponsoring a Technology Workshop, please contact Kristen Schott; 508-614-1239; kschott@ibcusa.com
12:30
Networking Luncheon, Exhibit and Poster Viewing
Single Use Systems for Vaccine Production
Shared Session with Single-Use Applications for Biopharmaceutical Manufacturing
1:55
Chairperson's Opening Remarks
Philippe-Alexandre Gilbert, Ph.D., Senior Scientist, Medimmune Vaccines
Philippe-Alexandre Gilbert, Ph.D., Senior Scientist, Medimmune Vaccines
Keynote Presentation
2:00
Universal, Rapid Deployment, Single-Use Manufacturing: A Paradigm Shift for VaccinesVaccine manufacturing is undergoing a major shift. Recent successes demonstrate that rapid deployment, universal, single-use vaccine production is enabling developers to avoid traditional bottlenecks impacting quality, cost, time to first dose and supply. In addition, these successes have demonstrated the ability to accommodate mammalian, insect or microbial cultures that produce either subunit, live virus, attenuated virus, inactivated vaccines or VLPs including H1N1 swine flu vaccine. The paper will review recent cases involving the deployment of flexible vaccine manufacturing platforms.
Parrish M. Galliher, Founder and Chief Technology Officer, Xcellerex, Inc.
Audience Interactive Panel Discussion
2:45
Disposable processing technologies have enabled new approaches to manufacturing. Larger disposable upstream bioreactors and fully disposable downstream processing made possible with multi-column continuous chromatography enable a self contained manufacturing platform. The panel will discuss this fully disposable and deployable bioprocess train.
Moderator: Peter Latham, President, BioPharm Services US
Panelists:
Parrish M. Gallliher, Founder and Chief Technology Officer, Xcellerex, Inc.
Richard A. Richieri, Senior Vice President, Manufacturing/BioProcess Development, Avid Bioservices, Inc.
Additional panelists to be announced
3:30
Networking Refreshment BreakLast Chance for Exhibit & Poster Viewing
Technology Workshop
4:00
GE Healthcare has now integrated all the features of disposable processing into ReadyCircuits; a new platform of disposable components that are combined to create self contained process modules as basic as buffer filtration or as complex as a complete TFF operation. This workshop outlines the ReadyCircuit portfolio, shows examples of how easily circuits can be designed, and how quickly one can configure a circuit through a new on- line configurator.
Karen Green, Senior Product Manager, GE Healthcare
4:30
Optimizing Single Use Cell Harvest Technologies for Vaccine Production
Current bioprocessing technologies have limited applications in vaccine and cell therapy manufacturing as they are typically optimized for the manufacture of recombinant proteins. Most cell harvest technologies aim at efficiently removing cells but not at maximizing viable cell density, viability, and recovery; parameters that are critical for vaccine and cell therapy manufacturing. This presentation outlines a next generation single use cell harvest technology that supports the specific requirements of vaccine production applications.
Sunil Mehta, B.Pharm, Ph.D., Director, Technology Development, KBI Biopharma Inc.
Current bioprocessing technologies have limited applications in vaccine and cell therapy manufacturing as they are typically optimized for the manufacture of recombinant proteins. Most cell harvest technologies aim at efficiently removing cells but not at maximizing viable cell density, viability, and recovery; parameters that are critical for vaccine and cell therapy manufacturing. This presentation outlines a next generation single use cell harvest technology that supports the specific requirements of vaccine production applications.
Sunil Mehta, B.Pharm, Ph.D., Director, Technology Development, KBI Biopharma Inc.
Unpublished New Data
5:00
Disposable Bioreactors for Viral Vaccine Production: Challenges and Opportunities
The implementation of disposable bioreactors has been quite successful for the production of recombinant proteins and monoclonal antibodies. This presentation will focus on the specificities of viral vaccine upstream processes (micro-carriers culture) and will highlight GSK Biologicals' methodology to implement such devices in industrial processes. A comparison with current stainless steel processes will be discussed, including cost of goods and biosafety.
Jean-François Chaubard, Director, Industrial Viral Bulk Production, GlaxoSmithKline Biologicals, Belgium
The implementation of disposable bioreactors has been quite successful for the production of recombinant proteins and monoclonal antibodies. This presentation will focus on the specificities of viral vaccine upstream processes (micro-carriers culture) and will highlight GSK Biologicals' methodology to implement such devices in industrial processes. A comparison with current stainless steel processes will be discussed, including cost of goods and biosafety.
Jean-François Chaubard, Director, Industrial Viral Bulk Production, GlaxoSmithKline Biologicals, Belgium
5:30
Sensors for Disposable Bioreactors and Integration with PAT/QbD
Abstract unavailable at press date.
Philippe-Alexandre Gilbert, Ph.D., Senior Scientist, MedImmune Vaccines
Abstract unavailable at press date.
Philippe-Alexandre Gilbert, Ph.D., Senior Scientist, MedImmune Vaccines
6:00
Close of Tuesday Sessions
Workshop: Monday | Main Conference: Monday | Tuesday | Wednesday
7:30
Networking Coffee
7:55
Chairperson's Opening Remarks
Jeffrey T. Blue, Ph.D., Research Fellow, Bioprocess Analytical and Formulation Sciences, Merck Research Laboratories
Jeffrey T. Blue, Ph.D., Research Fellow, Bioprocess Analytical and Formulation Sciences, Merck Research Laboratories
Keynote Presentation
8:00
Case
Study
Study
The Remaking of a Biopharm Manufacturing Organization and its Impact on 2009 Production of H1N1 VaccineOur TechOps organization has undergone a remarkable transformation since the unit was acquired as the Chiron Corporation. We describe the complete remaking of a biopharma manufacturing organization, in the context of our response to a historic global pandemic. One obstacle after another was overcome in the H1N1 campaign: seed strains, production, ramping up staff, supply chain and production equipment. With these changes and a new culture of action, agility and sense of purpose, Novartis produced over 116 million doses of life-saving vaccine in eight months.
Matthew Stober, Ph.D., Global Head of Technical Operations, Novartis Vaccines & Diagnostics
Production of Conjugate and Multi-Component Vaccines
8:45
Case
Study
Degradation Mechanisms for Polysaccharide Conjugates Associated with Aluminum Containing AdjuvantsStudy
During the development of a novel polysaccharide conjugate vaccine program, multiple aluminum containing adjuvants were screened. Degradation of conjugates containing a phosphodiester bond within the backbone of the polysaccharide structure was observed. Polysaccharide conjugates adsorbed onto aluminum hydroxyphosphate sulfate adjuvants resulted in loss of immunogenicity in vivo and a loss in recoverable dose via an in vitro potency assay. Conversely, the same polysaccharide conjugates adsorbed to an aluminum phosphate adjuvant showed no loss of immunogenicity or dose.
Jeffrey T. Blue, Ph.D., Research Fellow, Bioprocess Analytical and Formulation Sciences, Merck Research Laboratories
9:15
Case
Study
Process Development of Multi-Component DNA VaccinesStudy
Several candidate multi-component DNA vaccines have been developed at our site. Process development has been undertaken with 10 L runs and scaled up to 400 L for GLP and cGMP manufacture. Downstream purification employed a series of disposable techniques in which the capacity bottlenecks of cell lysis and primary recovery were removed. High concentrations of up to 12 mg/ml were achieved to accommodate the formulation of multiple plasmids delivered at a small volume.
Henry Hebel, Chief Operating Officer, VGXI, Inc.
9:45
Conjugate Vaccines: Design and Development Considerations towards a Seamless Process Transfer
Abstract unavailable at press date.
A. Krishna Prasad, Ph.D., Director, BioTherapeutics Research and Development, Pfizer, Inc.
Abstract unavailable at press date.
A. Krishna Prasad, Ph.D., Director, BioTherapeutics Research and Development, Pfizer, Inc.
10:15
Networking Refreshment Break
Scale-Up and Technology Transfer
10:45
Case
Study
Evaluating Risk and Impact of Process ChangesStudy
Processes to produce biopharmaceutical products change throughout the product life cycle due to process optimization, scale, equipment and facility. Comparability of product to previous clinically relevant lots may be required to demonstrate the effect of changes with respect to identity, strength, quality, purity or potency as they may relate to the safety and effectiveness of the product. This presentation will present a case study of such a comparability strategy used for a Phase 2 product.
Sara Terpening, Ph.D., Director, Manufacturing, Testing and Technical Services, DynPort Vaccine Company LLC
11:15
Transfer, Scale-up and Manufacturing of Norovirus VLPs: Managing Issues and Facilitating Success Through the use of Generic Process Steps, Disposable Materials and a "Transfer Process"
LigoCyte is a biotechnology company specializing in Virus-Like Particle (VLP) vaccines. Expression systems, purification processes and quality control methods are developed in our laboratories utilizing generic unit operations and disposable materials. LigoCyte's experience in production of clinical supplies using multiple contract organizations will be presented. We will highlight the role of generic processes and disposable materials in facilitating transfer, and the role of a "transfer process" and open communication in overcoming issues of scale-up and release testing.
Bryan L. Steadman, Senior Director, CMC Operations and Project Management, LigoCyte Pharmaceuticals, Inc.
LigoCyte is a biotechnology company specializing in Virus-Like Particle (VLP) vaccines. Expression systems, purification processes and quality control methods are developed in our laboratories utilizing generic unit operations and disposable materials. LigoCyte's experience in production of clinical supplies using multiple contract organizations will be presented. We will highlight the role of generic processes and disposable materials in facilitating transfer, and the role of a "transfer process" and open communication in overcoming issues of scale-up and release testing.
Bryan L. Steadman, Senior Director, CMC Operations and Project Management, LigoCyte Pharmaceuticals, Inc.
11:45
Technology Workshop
IBC's Technology Workshops offer supplier and service companies the opportunity to present product and service offers directly to the audience at the conference. For further information on sponsoring a Technology Workshop, please contact Kristen Schott; 508-614-1239; kschott@ibcusa.com
IBC's Technology Workshops offer supplier and service companies the opportunity to present product and service offers directly to the audience at the conference. For further information on sponsoring a Technology Workshop, please contact Kristen Schott; 508-614-1239; kschott@ibcusa.com
12:15
Lunch on Your Own
1:55
Chairperson's Opening Remarks
Vu L. Truong, Ph.D., Vice President, Research and Development, Aridis Pharmaceuticals
Vu L. Truong, Ph.D., Vice President, Research and Development, Aridis Pharmaceuticals
Analytical Characterization and Release Specifications
2:00
Analytical Characterization of HIV Vaccine Antigens
Abstract unavailable at press date.
Antu K. Dey, DPhil, Investigator, Novartis Vaccines & Diagnostics
Abstract unavailable at press date.
Antu K. Dey, DPhil, Investigator, Novartis Vaccines & Diagnostics
Vaccine Formulation, Stability and Delivery
2:30
Strategies for the Development of Stable Live Virus Vaccine Formulations
This presentation will review the major challenges and strategies used to develop live virus vaccine formulations by using adenovirus-based vaccines as a case study. The presentation will emphasize the need to probe mechanism/s of degradation as the basis for screening studies to identify stabilizing excipients. The data suggest that control of generalized degradation pathways is an effective strategy for developing platform formulations for live virus vaccines.
Robert K. Evans, Ph.D., Director, Bioprocess Analytical & Formulation Sciences, Merck Research Laboratories
This presentation will review the major challenges and strategies used to develop live virus vaccine formulations by using adenovirus-based vaccines as a case study. The presentation will emphasize the need to probe mechanism/s of degradation as the basis for screening studies to identify stabilizing excipients. The data suggest that control of generalized degradation pathways is an effective strategy for developing platform formulations for live virus vaccines.
Robert K. Evans, Ph.D., Director, Bioprocess Analytical & Formulation Sciences, Merck Research Laboratories
3:00
Production of an Oral Adenoviral Vector Vaccine
PaxVax is developing recombinant, replication-competent human adenovirus serotype 4 (Ad4) vectors capable of expressing protein antigens for use as orally delivered vaccines. These vaccines are designed to target and infect the mucosa with the intent of eliciting mucosal and systemic immune responses. Proof-of-concept evaluation for all aspects of this vaccine platform, including vector design, small-scale GMP manufacturing, oral dosage formulation for PaxVax's Phase 1 clinical testing will be discussed.
Paul Shabram, Vice President, Operations, PaxVax
PaxVax is developing recombinant, replication-competent human adenovirus serotype 4 (Ad4) vectors capable of expressing protein antigens for use as orally delivered vaccines. These vaccines are designed to target and infect the mucosa with the intent of eliciting mucosal and systemic immune responses. Proof-of-concept evaluation for all aspects of this vaccine platform, including vector design, small-scale GMP manufacturing, oral dosage formulation for PaxVax's Phase 1 clinical testing will be discussed.
Paul Shabram, Vice President, Operations, PaxVax
3:30
Networking Refreshments
3:45
Development of a VLP Platform for the Delivery of Peptidic Epitopes with Emphasis on a Malaria Vaccine
Current limitations of the RTS,S vaccine have been a requirement for reactogenic adjuvants and transient protection. A further potential complication is that the VLP carrier is derived from a human pathogen (HBV). To circumvent these problems we have developed a non-human pathogen VLP platform derived from the core protein of a rodent hepadnavirus (WHcAg). A CS-WHcAg hybrid VLP is very immunogenic in mice and is capable of eliciting neutralizing anti-CS antibodies that prevent P.falciparum/P.berghei hybrid sporozoite infection in vivo.
David R. Milich, Ph.D., Chief Executive Officer/President, The Vaccine Research Institute of San Diego
Current limitations of the RTS,S vaccine have been a requirement for reactogenic adjuvants and transient protection. A further potential complication is that the VLP carrier is derived from a human pathogen (HBV). To circumvent these problems we have developed a non-human pathogen VLP platform derived from the core protein of a rodent hepadnavirus (WHcAg). A CS-WHcAg hybrid VLP is very immunogenic in mice and is capable of eliciting neutralizing anti-CS antibodies that prevent P.falciparum/P.berghei hybrid sporozoite infection in vivo.
David R. Milich, Ph.D., Chief Executive Officer/President, The Vaccine Research Institute of San Diego
4:15
Formulation Impacts of Novel Vaccine Delivery and Packaging Systems
Abstract unavailable at press date.
Vu L. Truong, Ph.D., Vice President, Research and Development, Aridis Pharmaceuticals
Abstract unavailable at press date.
Vu L. Truong, Ph.D., Vice President, Research and Development, Aridis Pharmaceuticals
4:45
End of Conference
Bottom menu
Copyright IBC Life Sciences, a part of Informa Life Sciences Group. | Phone: 800.390.4078 | Email: reg@ibcusa.com