Continuous Manufacturing of Biologics: A Journey from Concept to Reality
15th September 2021 | 2:00pm IST / 4:30pm CST / 9:30am GMT / 10:30am CET | Himanshu Gadgil, CSO and Whole-Time Director at Enzene Biosciences Ltd. and Ganesh Kumar, MS, Market Entry Strategy Manager at Sartorius |BOOK FREE SEAT FOR THIS WEBINAR
Enzene Biosciences has been one of the early movers in the development of continuous manufacturing platforms for the production of Biologics. The company has developed multiple products using their continuous manufacturing platform which are now being tested in clinical studies. This talk encapsulates the learnings in developing this platform from early stages of development to scale-up and GMP manufacturing. Key areas include challenges specific to continuous manufacturing such as process optimization, process characterization, automation, in-line process analytics with an emphasis on the considerations towards the design of the manufacturing plant. Additionally, elucidation of emerging opportunities with respect to lean manufacturing, increased volumetric productivity, reduction of manufacturing footprint, and its resulting impact on lower COGs will also be discussed along with a case study on factors for conversion of the fed-batch process to a perfusion process. Concluding the talk with a precis of the crucial drivers which are leading to the emergence of continuous manufacturing as the preferred manufacturing platform for Biologics production.
Presented by Himanshu Gadgil, CSO and Whole-Time Director at Enzene Biosciences Ltd.
Dr. Himanshu Gadgil serves as the Whole-time Director at Enzene Biosciences Ltd. presiding overall business functions of the company. Under his services, Enzene has grown from start-up biotech to a multi-vertical, multi-site product development and manufacturing service based biopharmaceutical company. Prior to Enzene, he worked as the Sr. Vice President at Intas Pharmaceutical Ltd. where he was instrumental in turning around the commercial product pipeline by launching several biosimilar products in multiple geographies. During his stint in the US, he led different facets of the process and product development at Amgen spearheading IND, BLA, and Market authorizations of various blockbuster biotech products. At the inception of his career, he joined Waters Corporation where he pioneered the development of QBD enabling multi-attribute methodologies for biopharmaceutical characterisation. Himanshu holds a Ph.D. in Biochemistry from the University of Tennessee and is a passionate scientific leader as well as an innovator with over 50 publications and patents.
Followed by Ganesh Kumar, MS, Market Entry Strategy Manager at Sartorius
Ganesh started his career at Lonza, Singapore, where he was actively involved in the tech transfer, validation, and large-scale commercial manufacturing of blockbuster mAbs. Ganesh joined Sartorius in 2016 as a Process Engineer/Consultant and in his current role in the Protein-Based Therapies team as a Market Entry Strategy Manager at Sartorius, Ganesh collaborates with clients and business areas on process positioning, building the technical platform, and launching solution packages for process intensification. He has over eight years of experience in the biopharmaceutical industry, both as an end-user and a solution provider. He is based in Göttingen, Germany.
Sponsored by 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.