In this presentation, we will explore the main upstream vaccine manufacturing processes, taking into account the choice of the expression system, the way the biological preparation is introduced into the production cell and as flexible single-use bioreactors, rapid process development, sizing and protection improve the quality of vaccines, save lives and help ensure compliance.
Bioproduction facilities are under tremendous pressure due to the high demand for gene therapy products such as adeno-associated recombinant viral vectors (AAVs) manufactured under current Good Manufacturing Practice (GMP) conditions. The limitations of the scaling-up process are rarely considered when developing clinical trials, with many facilities simply expanding the protocols, procedures, and methods for testing suspended cell stacks. To demonstrate the importance of cost savings associated with the choice of scaling processes, this study provides a detailed analysis of cost modeling comparing the production of viral vectors in cells suspended in cell stacks with viral vectors produced in bioreactors, in suspension, or using a bioreactor or join an iCELLis® fixed-bed bioreactor.
Speakers
Helene Porac
Vice President of Technical Communications and Regulatory Strategy
Over the past 20 years, Helene has played a key role in the development of Pall’s single-use techniques, while being heavily involved in manufacturing, quality, and regulatory aspects. He has over 30 years of experience in the biopharmaceutical industry, the last 29 of which at Pall Corporation. He regularly speaks at ad hoc technology conferences with a strong focus on validation and the general aspects of process integration. She is also involved in several industry associations with a strong focus on BPOG and serves on the BPSA board.
Andrea Pedregal
Bioreactor Applications Manager (EMEA), Science and Laboratory Services
Andreia is the manager of the Pall Bioreactor Application Scientist team in Europe. Through it, he supports clients who use Pall bioreactors to develop and manufacture cell and gene therapies, oncolytic, vaccines, monoclonal antibody therapies, and more. Andreia holds a master’s degree in biotechnology engineering from the Faculty of Science and Technology, University of Algarve, Portugal. He has over 10 years of experience in marginal mammalian rearing and bioprocess design and optimization, gained from his previous positions at the Animal Cell Biotechnology Laboratory and Experimental Medicine Laboratory at ULB Private Research University in Brussels, Belgium.