This three-day in-person workshop will explore the critical issues at the various stages of vaccine development. International experts will lead delegates in developing their understanding in the research, operational, and regulatory challenges of the vaccine market.
This workshop is suitable for:
scientists new to the vaccines sector (recent graduates / research scientists)
scientists and technical managers looking to broaden their knowledge in various vaccine technologies and platforms
project managers, funders and policy-makers wanting to gain an understanding in vaccines
Click HERE for a downloadable version of the course agenda!
30 minutes
Dr. Stacy Springs is the Executive Director at the MIT Center for Biomedical Innovation (CBI). The Center integrates the Institute’s technical, scientific, and management expertise to solve complex biopharmaceutical challenges. CBI leads multi-stakeholder, multidisciplinary research and educational initiatives with real world impact, including MIT’s Biomanufacturing Consortium, (BioMAN), and it’s Consortium on Adventitious Agent Contamination in […]
Following a survey of the main different vaccine technology platforms examples will be given for specific case studies. Gardasil® vaccine for prevention of cervical cancer is a great example of a Virus Like Particle (VLP) vaccine. Rotateq® vaccine for prevention of Rotavirus infection is an example of a live virus vaccine. Flublok quadrivalent is a protein-based vaccine for protection against Influenza. For protection against COVID-19 both the Moderna mRNA vaccine and the Pfizer mRNA vaccine are great examples.
50 minutes
Barry Buckland was Vice President of Bioprocess Development at the Merck Research Labs for more than a decade until 2009. For the past 6 years he has been Executive Director of NIIMBL (National Institute for Innovation in Manufacturing Biopharmaceuticals) and Visiting Professor at University College London (UCL). As a volunteer Barry acts as President of […]
The biopharmaceutical industry mounted an impressive response to the COVID-19 pandemic, but it was the companies that previously invested in platform-based technologies, such as mRNA and viral vectors, that were successful in gaining Emergency Use Authorization (EUA) and eventual approval most quickly. As a result, multiple safe and efficacious vaccines were authorized for emergency use, resulting in significant declines in severe disease and mortality, however, durable immunity to COVID-19 has not yet been achieved. While many biopharmaceutical companies have launched independent efforts to develop mRNA vaccines, it is important to reflect on efficacy and durability of legacy vaccines and what those platforms have to offer. Vaccine platforms offer speed of development and flexibility in manufacturing, however, not all antigens are amenable to a specific platform, and there are strategic trade-offs in developing a vaccine for rapid emergency use deployment vs. a long-term product for endemic prophylaxis. Here we will present case studies from live viral and subunit vaccine platforms, and how continued investment in these established platforms have enabled speed and innovation to support both EUA and long-term commercial manufacturing.
50 minutes
Tara joined Merck in 2007 after obtaining her PhD in Molecular Virology from the University of Pittsburgh School of Medicine. During her 15 years at Merck, she has developed expertise at various nodes in the life cycle of vaccines. She has supported LVV, subunit, and mRNA vaccines from Discovery to Manufacturing and through patient access. In […]
11:30
20 minutes
Global Health agencies have relied on vaccination as one of the most effective treatment options during epidemics and more recently pandemics associated with viral disease. Vaccination campaigns have been shown to significantly reduce the number of deaths caused by infectious agents. With the introduction of cell culture and DNA recombinant technologies vaccine design has changed dramatically. Permissive cell lines have allowed the production of attenuated and inactivated vaccines. The advent and use of newer manufacturing technologies to produce vaccines though the use of, for example, virus like particles, vectored vaccines and chimeric vaccines bring specific quality and safety issues which need to be addressed. The overall safety of vaccines is still of paramount importance and this presentation will focus on regulatory expectations from a global view. In addition, we will address the impact of new vaccine developments which are now being used to supply high quality and effective products.
50 minutes
Alison started her career in academic research with a strong interest in the role of viruses in various pathogenic conditions. On moving to the contract testing sector in late 1990s, Alison led a number of teams in different divisions within Merck and currently holds the position of Global Head of Technical and Scientific Solutions. During […]
12:40
1 hour
Adventitious agent contamination of cell culture-based biomanufacturing operations for the production of protein and monoclonal antibody biotherapeutics are infrequent, but when they do occur, they are very costly, impact manufacturing operations, and can potentially impact patient safety and product supply. In response to this need, the MIT Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) began the confidential collection and analysis of industry-wide viral contamination data with an emphasis on “lessons learned”. The mission of the CAACB is to pool and to share knowledge, experience and practices in the area of adventitious agent contamination in biomanufacturing. The Consortium is providing a safe and collaborative environment for networking and information exchange focused on identifying best industry practices in contamination response, corrective and preventive actions, and promoting the development of new technologies to detect adventitious agents and mitigate risk of contamination. This presentation will cover the learnings from this study, including identified industry risks and best practices to mitigate those risks. This talk will discuss some of the lessons learned from the collaborative work done by the CAACB and their implications for vaccine manufacture.
50 minutes
Dr. Stacy Springs is the Executive Director at the MIT Center for Biomedical Innovation (CBI). The Center integrates the Institute’s technical, scientific, and management expertise to solve complex biopharmaceutical challenges. CBI leads multi-stakeholder, multidisciplinary research and educational initiatives with real world impact, including MIT’s Biomanufacturing Consortium, (BioMAN), and it’s Consortium on Adventitious Agent Contamination in […]
The Future Vaccine Manufacturing Research Hub (Vax-Hub) is an academic collaboration led by UCL Biochemical Engineering and the University of Oxford. Vax-Hub comprises world-leading experts in vaccinology, synthetic biology, biochemical, materials, and system engineering working on integrated discovery through to bioprocess manufacture of next-generation vaccines. This presentation will provide an overview of developments within Vax-Hub, from innovative tools and technologies to outreach activities.
50 minutes
Stefanie Frank is a Lecturer in Synthetic Biology at the UCL Department of Biochemical Engineering. Her research focuses on engineering self-assembling proteins for biotechnology applications. Stefanie’s work has found applications in biocatalysis, drug-delivery and vaccine design, the la_er as Co-I on the UCL-Oxford The Future Vaccine Manufacturing Research Hub (Vax-Hub). She leads the Vaccines Bioprocess […]
15:20
20 minutes
Adjuvants are vaccine components that enhance the magnitude, breadth, and durability of the immune response. Since its introduction in the 1920s, insoluble Alum remained the only adjuvant licensed for human use for the next 70 years. However, since the 1990s, a further five adjuvants have been included in licensed vaccines. Yet, the molecular mechanisms by which adjuvants work remains only partially understood. A revolution in our understanding of the molecular pathways of activation of the innate immune system through pattern recognition receptors (PRRs) has allowed a mechanistic understanding of adjuvants. The intervening period has witnessed many conceptual advances, including the notion that tissue damage, different forms of cell death, and metabolic regulators and nutrient sensors, can all profoundly activate the innate immune system and adaptive immunity. Also, recent advances in the use of systems biology to probe the molecular networks driving immune response to vaccines in humans is revealing new mechanistic insights and providing a new paradigm for the vaccine discovery-development process. I will discuss the emerging concepts in adjuvant science, and highlight how our expanding knowledge about innate immunity and systems immunology are revitalizing the science and development of adjuvants.
50 minutes
Derek is currently a Senior Advisor in GSK Vaccines R&D and a Senior Fellow. He previously served on the Fellows Council, and he is now on the Fellows Leadership Team. Prior to Derek’s current role, he was the Global Head of Discovery Support and New Technology in GSK Vaccines. Previously, Derek was VP, Global Head […]
The manufacture of conjugate vaccines is very complex. Carrier proteins and capsular polysaccharides are produced by fermentation processes, while capsular polysaccharide activation and conjugation to the carrier protein are chemically mediated. Process development requires a cross-discipline team of scientists with backgrounds in analytical chemistry, biochemistry, bioprocess, chemistry, engineering, statistics, and vaccines research. Throughout the development process, care must be taken to ensure that the physicochemical, biochemical, and immunogenic properties of the conjugate are consistently maintained across production scales. This talk will highlight some of the manufacturing and development challenges encountered with conjugate vaccines and potential mitigations.
50 minutes
Steve has been an Associate Research Fellow in the Bioprocess R&D group at the Pfizer-St. Louis site since 2010, where his team has focused on process development of polysaccharide-protein conjugates as biotherapeutic drug candidates for bacterial vaccines against pneumococcal, staphylococcal and meningococcal serotypes. Prior to this position, he spent 16 years in the Discovery Medicinal […]
17:20
10 minutes
Dr. Stacy Springs is the Executive Director at the MIT Center for Biomedical Innovation (CBI). The Center integrates the Institute’s technical, scientific, and management expertise to solve complex biopharmaceutical challenges. CBI leads multi-stakeholder, multidisciplinary research and educational initiatives with real world impact, including MIT’s Biomanufacturing Consortium, (BioMAN), and it’s Consortium on Adventitious Agent Contamination in […]
08:50
10 minutes
Barry Buckland was Vice President of Bioprocess Development at the Merck Research Labs for more than a decade until 2009. For the past 6 years he has been Executive Director of NIIMBL (National Institute for Innovation in Manufacturing Biopharmaceuticals) and Visiting Professor at University College London (UCL). As a volunteer Barry acts as President of […]
Current regulations and guidance define several pathways that facilitate expedited product development. These regulatory mechanisms allow for enhanced interaction between the sponsor and the FDA review team, flexible submission schedules, and, in some case, shortened review timelines. These pathways were created to better support development of new products where a defined unmet medical need exists. In response to the emergence of viruses that have caused regional and global public health emergencies, Ebola virus in 2014 and SARS-CoV-2 in 2020, respectively, the Agency conducted expedited reviews based on existing review mechanisms, but also utilized additional regulatory resources to facilitate the availability of safe and effective vaccines to help prevent disease from each of these viruses. This presentation will highlight the history of regulations related to vaccine development, review activities associated with vaccine development during an ongoing pandemic, and how lessons learned will be used to facilitate vaccine development and availability in the event of future public health emergencies.
50 minutes
Dr. Levis has been at the FDA since 1995. She currently serves as the Deputy Director of the Division of Viral Products in the Office of Vaccines Research and Review. In this position, she is responsible for the regulatory review oversight of both investigational and licensed viral vaccines
The 2014 outbreak of Ebola virus disease in West Africa highlighted the lack of preparedness for combating infectious disease outbreaks. Since 1976, vaccine development had proceeded slowly and no candidate vaccines had progressed further than phase I trials. Ebola is only one of many known viruses with the potential to cause outbreaks. With the support of the WHO in identifying priority pathogens, and the formation of CEPI to provide funding, vaccine development was initiated with the aim of having vaccines available in readiness for future disease outbreaks. ‘Disease X’, to represent a disease caused by a previously unknown pathogen, was also considered. In the first days of 2020, the first ‘Disease X’ outbreak, caused by a virus later named SARS-CoV-2 occurred. Vaccine developers found ourselves attempting to put into place plans that were at an early stage of development, had not been funded and had not therefore been tested. Rather than working to produce a vaccine which could then be deployed in the ‘outbreak area’ we found ourselves attempting to develop a vaccine against a novel pathogen that was causing a pandemic whilst we ourselves were in the grip of that pandemic with every aspect of our work affected.
50 minutes
Professor Dame Sarah Gilbert is the Saïd Professor of Vaccinology at the Pandemic Sciences Institute, Nuffield Department of Medicine. Having worked on the early development of the ChAdOx1 vaccine platform technology including the first GMP manufacture and clinical trials, in early 2020 she began to lead the development of the vaccine later know as the […]
10:40
20 minutes
This presentation describes the mechanistic modeling and control of the manufacturing of viral, virus-like particle, subunit protein, and mRNA vaccines. After an overview of the progress for all of these vaccine types, the use of perfusion or continuous culture to increase productivity is discussed. Then a detailed description is provided on mechanistic models, sensor development, and control for continuous viral vaccine manufacturing in suspension culture. Results demonstrate smooth quasi-steady continuous operation over an extended period of time and good agreement between a mechanistic model and data for experiments carried out at a local contract manufacturing organization.
50 minutes
Dr. Richard D. Braatz is the Edwin R. Gilliland Professor of Chemical Engineering at MIT, where he conducts research into advanced biopharmaceutical manufacturing systems. In this role, he leads process data analytics, mechanistic modeling, and control systems for many projects, including on monoclonal antibody, viral vaccine, and gene therapy manufacturing within the Center of Biomedical […]
The development and manufacturing of vaccines has rich history and evolution, driving, adopting or adapting the science and technology boundaries of the time. As a vaccine progresses through the life cycle, from discovery to stablished product to end of life cycle, different factors dictate the decisions and paths organizations take. From the constraints of the scientific and technical knowledge, to the economics of production and distribution, our industry achieves a careful balance to ensure the continued delivery of life-saving vaccines. In this presentation, we will look through the lens of the manufacturer at factors playing significant roles as a vaccine candidate transitions from development to commercial manufacturing, from launch to mature product incorporating advances in science, technology and regulatory science and to a final transition at the end of the product life cycle.
50 minutes
Ms. Fino drives MassBiologics internal programs and CDMO services at the organization’s two FDA and EMA commercially approved gene therapy and vaccine manufacturing sites. Ms. Fino has over 30 years of experience as biotech executive. She was senior vice president for manufacturing operations for Protein Sciences Corp, and became the Site Head of Industrial Operations, […]
12:40
1 hour
Significant investment is being made in developing mRNA-based vaccines for infectious diseases such as Influenza and RSV with an expectation of speedy development with high efficacy. There are, however, several CMC pre-requisites to enable these expectations.
50 minutes
Kumar Namdev heads CMC Development and Industrialization in mRNA Center of Excellence in Sanofi. Kumar has more than 25 years of experience in CMC development, technology transfer, validation, licensure and life cycle management of biologics and vaccines. He has been in Sanofi for 14 years where previously he held roles to lead local and global […]
Here to be presented is case study on Pfizer’s journey to supplying COVID 19 Vaccine at unprecedented pace & scale. Kevin will give a high-level overview of Pfizer’s and BioNTech’s mRNA vaccine technology and bring us through us some of the key process innovations which facilitated rapid process development and scale up which were required to provide COVID 19 vaccine at a pandemic supply level.
50 minutes
Kevin is currently director of Sterile Injectables and Biotech Technology and a member of the Pfizer Global Supply Global Technology & Engineering team. In this role, Kevin and his team are responsible for providing technical leadership and support for all new and marketed vaccine/biological products. This scope includes 2nd generation process development, technology transfer, supply […]
08:50
10 minutes
Stefanie Frank is a Lecturer in Synthetic Biology at the UCL Department of Biochemical Engineering. Her research focuses on engineering self-assembling proteins for biotechnology applications. Stefanie’s work has found applications in biocatalysis, drug-delivery and vaccine design, the la_er as Co-I on the UCL-Oxford The Future Vaccine Manufacturing Research Hub (Vax-Hub). She leads the Vaccines Bioprocess […]
Translational development of new concepts for vaccines from discovery to the clinic has required unique processes tailored to the characteristics of each immunogen and final vaccine product. For recombinant vaccines, each immunogen may have its own properties and specifications that confer immunogenicity, and development usually begins with optimizing production of a selected sequence, followed by serial development of steps for recovery of the antigen. With these materials in hand, product development follows formulation development and stability studies. This approach to process development is linear, with limited feedback into prior stages including discovery and early evaluation of candidate vaccines. Iterative learning from one vaccine to another can be also limited and process development often starts new each time. This talk will present an integrated platform-like approach to recombinant vaccine development that incorporates an iterative design process emphasizing molecular design of antigens, strain engineering and integrated straight-through purification for recombinant proteins with examples for rotavirus and SARS-CoV-2 vaccine candidates.
50 minutes
J. Christopher Love is the Raymond A. (1921) and Helen E. St. Laurent Professor of Chemical Engineering and member of the Koch Institute for Integrative Cancer Research at MIT. He is the founding director of the Alternative Host Research Consortium at MIT and faculty director of the MIT Venture Mentoring Service (VMS). Dr. Love has also […]
Delivering effective viral vaccines to the market on time is critical for preventing and controlling infectious diseases. Traditional manufacturing processes are highly complex, require extensive process development efforts, and tend to suffer from a lack of scalability to rapidly reach commercial scale capacity. Advances in integrated and automated manufacturing technologies result in cost-effective, scalable, and highly productive processes. Those technologies are considered as flexible by design as they can accommodate various expression systems, vaccine applications and capacity requirements, while streamlining the vaccine development process. Structured fixed-bed bioreactors can achieve high cell densities with superior specific cell productivities through homogeneous cell distribution and media flow. They sustain reproducible results from small to large scale in a reduced volume and simplify the time to scale-up. Additionally, the integration of upstream and midstream process units with a highly intensified fixed-bed bioreactor provides automated continuous processing, drastically reducing the complexity, footprint and CAPEX while meaningfully reducing the cost per dose. In this presentation, the speaker will focus on technology innovations leveraging process intensification and continuous processing to deliver capacity at low footprint, process flexibility and accelerated development and scale-up timelines.
50 minutes
Mathias Garny is the CEO of Univercells Technologies where he oversees the company’s operations and leads the company’s strategy development and implementation. Prior to this role, Mathias played a key role in founding Univercells (Univercells Technologies parent company) respectively serving as Chief Financial Officer and Chief Commercial Officer. He was trained as a strategy consultant and […]
Post approval changes are common for licensed vaccines. Such changes to the license may be done to implement cost-saving process improvements, change a formulation, or put a new manufacturing site into service. Use of a comparability protocol can speed implementation of changes. This presentation will introduce the concept of comparability protocols and discuss two vaccine case studies that used comparability protocols to implement changes to the license.
50 minutes
Dr. Post is Head of Regulatory Affairs Development, US Vaccines at Sanofi. She is an experienced biopharmaceutical professional with a proven track record of successful development and implementation of regulatory strategies, progressing products from pre-clinical through global approval and post-marketing changes. She is the Regulatory head that led the team responsible for the filing and […]
11:30
20 minutes
mRNA/Lipid Nanoparticle (LNP) technology has evolved rapidly over the last decade, significantly changed the vaccine and therapeutics landscape, and recently proven its technology potential with commercial successes in two COVID-19 vaccines. Catalent has contributed to the evolution of this exciting technology field since 2016, by helping clients to develop, manufacture, and test vaccines or drugs for cancer, infectious disease, or genome editing applications. In this presentation, we will share our process development and manufacturing experience in the workflow from DNA, mRNA, LNP, to fill finish. Unique challenges in developing and manufacturing this nascent technology will be covered. Outlook on further evolution of DNA and mRNA technology to increase product quality and reduce development time will be discussed. Challenges and opportunities in LNP processing and stabilization will be discussed.
50 minutes
Jingtao is a Scientific Director in the Biologics Group at Catalent Pharma Solutions, responsible for developing new technical capabilities and product solutions to solve clients’ pressing pharmaceutical problems. His current focus is introducing, developing, and establishing development and manufacturing capabilities in LNP for mRNA modalities within Catalent. Prior to Catalent, he was a principal scientist […]
12:40
1 hour
At the Bill & Melina Gates Foundation we envision a world where every person has the opportunity to live a healthy, productive life. To that end the foundation invests heavily in vaccines, from discovery, to manufacturing, delivery and policy, an effort that has aided the reduction of global measles, paralytic polio, and COVID-19 disease burden. We are currently facing the looming existential threat of climate change, which affects the most basic requirements of health: clean air, safe water, sufficient food and adequate shelter. Vaccine discovery, development and commercialization can all play a role in mitigating the risk of climate change related health crises. Maximizing manufacturing efficiency, by producing a higher yield per unit of each input, has potential to dramatically reduce cost of the final product. New and evolving tools in computation, materials science, and vaccine delivery similarly provide opportunities for efficiency gains across multiple dimensions, including minimizing development time, streamlining tech transfer activities, and maximizing protective responses and vaccine coverage while minimizing injection pain and adverse events. New technologies that control vaccine release may be deployable to maximize efficiency for existing vaccines and achieve robust protection against intractable infections like HIV and malaria.
50 minutes
Dr. Silverman is an immunologist by training and has spent the majority of her career working in the Global health space. Her PhD in microbiology & immunology focused on cellular mechanisms enabling immune evasion by leishmania parasites. Next she investigated the molecular etiology of template-directed proteopathies as a Post-Doc and then Faculty Researcher at the […]
Discussion Moderator: Barry C. Buckland University College London Discussion Panelists: Dame Sarah Gilbert University of Oxford Robin Levis U.S. Food and Drug Administration Judith Maxwell Silverman The Bill & Melinda Gates Foundation Tara Tagmyer The Bill & Melinda Gates Foundation
1 hour
Tara joined Merck in 2007 after obtaining her PhD in Molecular Virology from the University of Pittsburgh School of Medicine. During her 15 years at Merck, she has developed expertise at various nodes in the life cycle of vaccines. She has supported LVV, subunit, and mRNA vaccines from Discovery to Manufacturing and through patient access. In […]
Dr. Silverman is an immunologist by training and has spent the majority of her career working in the Global health space. Her PhD in microbiology & immunology focused on cellular mechanisms enabling immune evasion by leishmania parasites. Next she investigated the molecular etiology of template-directed proteopathies as a Post-Doc and then Faculty Researcher at the […]
Dr. Levis has been at the FDA since 1995. She currently serves as the Deputy Director of the Division of Viral Products in the Office of Vaccines Research and Review. In this position, she is responsible for the regulatory review oversight of both investigational and licensed viral vaccines
Professor Dame Sarah Gilbert is the Saïd Professor of Vaccinology at the Pandemic Sciences Institute, Nuffield Department of Medicine. Having worked on the early development of the ChAdOx1 vaccine platform technology including the first GMP manufacture and clinical trials, in early 2020 she began to lead the development of the vaccine later know as the […]
Barry Buckland was Vice President of Bioprocess Development at the Merck Research Labs for more than a decade until 2009. For the past 6 years he has been Executive Director of NIIMBL (National Institute for Innovation in Manufacturing Biopharmaceuticals) and Visiting Professor at University College London (UCL). As a volunteer Barry acts as President of […]
15:30
15 minutes
Dr. Stacy Springs is the Executive Director at the MIT Center for Biomedical Innovation (CBI). The Center integrates the Institute’s technical, scientific, and management expertise to solve complex biopharmaceutical challenges. CBI leads multi-stakeholder, multidisciplinary research and educational initiatives with real world impact, including MIT’s Biomanufacturing Consortium, (BioMAN), and it’s Consortium on Adventitious Agent Contamination in […]
MilliporeSigma
University College London
Oxford University
GSK
MIT
MIT
Catalent
Bill & Melinda Gates Foundation
Pfizer
Sanofi
Univercells
MassBiologics
Sanofi
MIT
U.S. Food & Drug Administration
MIT
University College London
Pfizer
Merck
The Engine | 750 Main Street, Cambridge, MA
Registration for the 2023 Vaccines Workshop has closed as of June 2.
Contact Marisia Ketchum (mketchum@mit.edu) for more information.
