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
Speakers
Clive Glover, PhD
Senior Marketing Manager, Cell & Gene Therapy
Pall Biotech
Rachel Legmann, PhD
Senior Manager, Process Development Services
Pall Biotech
Case Study: An End-to-End Solution for Large Scale Adenovirus Manufacturing
Maximize Speed to Market Flexibility of Single-Use for Gene Therapy Manufacturing
Biotech | Pall Corporation webinar series
In 2019 Swissfillon were inspected and approved by the FDA to supply drug products into the USA, following on from EU approval in 2018. This young fill finish CMO was started in Switzerland in 2013 and built a state-of-the-art cGMP production facility from the ground up.
Swissfillon recognized early on that single-use systems met their requirements for multi-product manufacturing and would help their clients get their drugs to market faster.
During this case-study webinar, participants will learn:
- How working in partnership with a supplier can be part of a QbD approach to minimize risk
- Strategies & design improvements for single-use systems to reduce risk in the process
- How a shadowboard can be used to make single-use system leak tests, PUPSIT and the filtration process fast, safe and simple