Challenges and Risks in Development and Manufacture of Covid 19 Vaccines
30th June 2020 | 10:00am EST | Rajesh K. Gupta, Ph.D. Biologics Quality & Regulatory Consultants, LLC, North Potomac, Harish Rao, General Manager at Serum Institute of India Ltd, Amar Shrivastava, Senior Manager at Serum Institute of India Ltd |WATCH FOR FREE
Coronavirus disease (COVID-19) is a terrifying illness with high morbidity and mortality throughout the world and with devastating effects on businesses, economies, livelihood of individuals and producing depression/fear among populations due to prolonged lock downs. The only way to control the disease appears to be by developing herd immunity, either by infection or by universal vaccination. Achieving herd immunity by infection seems horrific with a significant burden on healthcare systems and sacrificing vulnerable population, including older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer. Achieving herd immunity through vaccination will take at least several months to years after development of a safe and effective vaccine. Typically, it takes a decade or more to develop a vaccine. Scientists and vaccinologists from academia, industry and Government organizations are enthusiastically working on more than 100 vaccine candidates to develop a safe and effective vaccine. There are numerous scientific, technical, manufacturing, and regulatory challenges and risks in developing vaccines in general, particularly under a fast timeline. This Webinar will go over the challenges and risks in developing Coronavirus vaccines with a view to identifying these for resolution and mitigation along with development of the vaccines.
Presented by Rajesh K. Gupta, Ph.D. Biologics Quality & Regulatory Consultants, LLC, North Potomac,USA
Rajesh K. Gupta has a Ph.D. in microbiology and is President and Principal Consultant at the Biologics Quality & Regulatory Consultants, LLC. He has more than 35 years’ experience in the development, production, testing and regulation of vaccines, working at both the regulatory agencies and the industry. At FDA, CBER, he was a Deputy Director and Lab Chief in the Division of Biological Standards and Quality Control, managing lot release of biological products, regulatory reviews of analytical methods in the biologics license applications (BLA), generation of reference standards and development of new methods. In his previous jobs, he worked at the Biologics Consulting Group, Wyeth, Chiron, Massachusetts Public Health Labs and National Institutes of Health (NIH) in the USA and at National Institute of Immunology and Central Research Institute in India. His major accomplishments are in adjuvants and delivery systems for vaccines, polysaccharide-protein conjugate vaccines, combination vaccines and development and validation of analytical methods. In these areas, he has published more than 100 papers in peer reviewed journals and books and made numerous presentations at scientific and regulatory meetings.
and followed by
ROLE OF SERUM INSTITUTE OF INDIA LIMITED IN DEVELOPMENT AND MANUFACTURE OF COVID 19 VACCINE
Presented by Harish Rao, General Manager at Serum Institute of India Ltd
Mr. Harish Rao is associated with Serum Institute of India Pvt Ltd in the capacity of General Manger- Recombinant and Combination Vaccines and leads multiple vaccine programs viz; HPV, Malaria and Ap Combination vaccines. A microbiologist by training, he has been associated with the Indian vaccine industry for more than 22 years. He leads a team of professionals involved in new product development, scale-up and manufacturing. He is involved in evaluation of new technologies for robustness, market potential and suitability with company’s business model. He is actively involved in interactions with various characterization labs, Clinical group and funding agencies. Presently he is part of the Covid vaccine initiatives by Serum Institute of India Pvt limited which is the world largest human vaccine manufacturing company.
and Amar Shrivastava, Senior Manager at Serum Institute of India Ltd
Mr. Amar Srivastava is working with Serum Institute of India Pvt. Ltd. for last 15 years as Senior Manager. He leads bacterial, viral vaccine and monoclonal antibodies program at SIIPL. Ability to independently develop and optimize the fermentation and purification process for vaccine and therapeutic protein by using bacteria, yeast, fungal and mammalian cell lines. Experienced in High-Tech facilities and process equipment requirements including, costing of projects specification, design, installation, and startup as well as cleanroom design and contamination control, Facility and equipment project engineering and management experience on new projects.
Presently he is leading ChAdOx1 Covid vaccine manufacturing at SIIPL.