Case Study: An End-to-End Solution for Large Scale Adenovirus Manufacturing
With several recent FDA approvals and a strong drug pipeline, the gene therapy market is coming of age and providing new hope for patients. As demand for these new therapies increases, a robust and scalable manufacturing process is critical. In this webinar, we will present an end user case study which illustrates the challenges and solutions to scale both the upstream and downstream process steps required to manufacture adenoviruses.
Participants will learn how to:
• Accelerate time to market for adenovirus manufacturing
• Design the process for scalability
• Reduce downstream processing time from 3 - 4 days to 1 day
Clive Glover, PhD
Senior Marketing Manager, Cell & Gene Therapy
Rachel Legmann, PhD
Senior Manager, Process Development Services
Maximize Speed to Market Flexibility of Single-Use for Gene Therapy Manufacturing
With the publication of the new chapters in USP <665> due in September join Ken Wong from Sanofi Pasteur, Desmond Hunt from United States Pharmacopeia and James Hathcock from Pall Biotech to get the latest updates.
Participants will learn:
- About the USP <665> standardized extraction solution protocol for manufacturing components and systems
- What is new and what has changed in USP <665> and <1665> (as of September 2020)
- The top issues influencing the alignment of the BioPhorum extractables protocol and USP <665>
- What level of data end-users can expect to see
- How to apply USP <665> data sets to support risk assessment and qualification of single-use systems
- The opportunities ahead for simplifying the adoption of single-use technologies
Don’t miss this free BioPharma Asia webinar to hear from subject matter experts serving on the USP and BPOG panels!