Vaccine Development & its Manufacturing using Integrated High Throughput Technology

The billions of doses of vaccines manufactured worldwide each year are used to vaccinate the healthy people. This is the fact which drives vaccine manufacturing to be among rigorously designed, manufactured, monitored & compliant health products. In order to produce this huge number of doses, there is a need to have a manufacturing process that strongly influences the cost effectiveness, volume, application of technologies involving ease of scale-up, flexible in nature, automated integration with different manufacturing unit operations, minimal manual intervention or hybrid for complex biologics like vaccines manufacturing. The use of integrated way of automation with different online sensors like IOTs, AI at different measurement points of processes to make the manufacturing process continuous, seamless, robust with high throughput yield, higher process capability with less time or no failure is the cornerstone of a modern, advanced & powerful manufacturing system. The concept of High Throughput Manufacturing is related to the time required for a product to pass through a manufacturing process converting raw materials into finished goods involving automation, integration of several unit operations with minimal manual intervention during the manufacturing. The ability to manufacture vaccines safely and consistently must be built on the theme with consistent quality, compliance, easier regulatory authorization in order to reach the market fast as manufacturing complexity is compounded by the need for different producing strains, types of vaccines & their processes. The present talk on “Vaccine Development and its manufacturing using integrated high throughput Technology” is going to address some challenges & opportunities and its full scale application to future biologics manufacturing.
Presented by Dr. S.K. Jana, Director – R&D and Manufacturing, Human Vaccine Development, Serum Institute of India Pvt. Ltd.

Dr. S.K. Jana is a Ph. D. in Bio-Chemical Engineering, an M. Tech. in Bio-chemical Engineering, B. Tech. in Chemical Technology, B. Sc. in Chemistry & PGDOM (Post Graduate Diploma in Operations Management). Education is from highly reputed Calcutta University, Jadavpur University Kolkata & IIT, Delhi.
Dr. Jana is having 30+ years of industrial experience in the fields of the Biopharmaceuticals & Vaccine industry, recombinant & non-recombinant Biosimilar product development from early stage, late stage development, pilot scale products development & commercial scale production for upstream & Downstream for microbial as well as Cell culture, Bio-analytic methods development, Polysaccharide-protein conjugate vaccine, Technology Transfer, Project planning & execution, extensive experience in process & Technology development, & Technology transfer with product delivery of Lovastatin, rh-G-CSF, Hepatitis-B vaccine (r-HBsAg), rh-IFN-α 2b, r-Streptokinase, rh-Insulin, r-Erythropoietin (CHO cell line), Hib conjugate, Penta valent & Cholera vaccines, Pneumococcal Polysaccharide Conjugate Vaccine with 17 patents & 9 publications.
Currently, as Director, he looks after R&D and Manufacturing of Human Vaccine Development related activities & other vaccines at Serum Institute of India Pvt Ltd., Pune, India.
Followed by Vikas Revankar, Head of Product Management and Marketing – Digital Portfolio, BioContinuum™ Platform – Merck

Vikas Revankar has over 20 years of experience in the IT industry spanning both application and infrastructure management services.  He’s held engineering and management roles in the pharma and Life Sciences industries for both tech startups and enterprise companies. Vikas specializes in the establishment and management of high-performing, global software organizations. In his current role as Head of Product Marketing, Vikas leads a team of product managers, engineers, and data scientists as they develop the strategy and roadmap for software, automation, and analytics technologies.  Vikas earned his Bachelor of Technology in Computer Science from Dr. Babasaheb Ambedkar Technology University and his MBA in Software Enterprise Management from the Indian Institute of Management, Bangalore.
Followed by Piergiuseppe Nestola, PhD Global Vaccine Technology Consultant at Sartorius

Piergiuseppe Nestola, PhD, is a Manager of Process Technology Consultants at Sartorius where he is responsible for providing scientific, technological and process leadership in the field of viral-based therapeutics. He holds a PhD degree in Chemical and Biochemical Engineering from Universidade Nova de Lisboa (PT), where he developed virus purification processes for vaccines and gene therapies.
Before joining Sartorius Piergiuseppe worked for several years at Janssen Vaccines AG in Bern (CH) as a scientist and team leader in the process development group. He was involved in developing and scaling up both viral vectors and protein-based vaccines in this role. Piergiuseppe has also been a judge at the Mass challenge and Bioexpert network incubators since 2018, supporting start-up life science companies.
Sponsored by Merck and SartoriusAbout Merck
Merck is a leading science and technology company in life science. Our comprehensive portfolio supports customers during all stages of the drug manufacturing process.  We offer a broad range of products and services including single-use manufacturing, filtration, chromatography and purification, virus reduction, pharma and biopharma raw materials, drug delivery compounds, and automation and analytics software. Our industry expertise and regulatory know-how help you get to clinic faster, allowing you to focus on what matters most — delivering safe, effective therapies sooner to the patients that need them most.
About Sartorius
Sartorius is a leading international partner for the biopharmaceutical industry. Our solutions are supporting our customers to produce drugs safely, timely and economically. Sartorius has a worldwide presence, with manufacturing, sales and R&D sites in more than 30 countries. A total solutions provider, our product portfolio covers nearly all steps of customers’ production processes. We hold global leading positions in key technology platforms like process filtration, fluid management, fermentation and cell cultivation. Our focus is on single-use technologies and added-value services to meet the rapidly changing technology requirements of the industry we serve.