Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety.
In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single-use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode.
In this webinar, you will learn:
- The context of closed processing
- Differences between closed and functionally closed processing
- The drivers for adoption
- Its practical implementation to a TFF step
Speakers
Dana Kinzlmaier
Merck
Applications Engineer
Dana is an applications engineer within our Global BioPharm Center of Excellence Applications Engineering group. Her areas of expertise include tangential flow filtration, single-use systems, analytical assays, development of proof statements, best practices, and integrated processing solutions for the production and purification of biotherapeutics. She holds a B.S. in chemical engineering from Slovak Technical University and a bioengineering certificate from the University of Massachusetts, Lowell.
Sarah Le Merdy
Merck
Strategy Deployment, Single-Use and Systems
Sarah holds a degree in biochemistry engineering from the National Institute of Applied Sciences of Lyon (INSA, France). She started her career with Merck in 2006 as a technical support engineer before moving to downstream field marketing with local, then global responsibilities. In her current role as part of the strategy deployment team, she specializes in downstream operations and systems.
Pharma and biopharma manufacturing
- Downstream Processing
Durée:43min
Langue:English
Session 1:présenté(e) June 5, 2021
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