BPI Contributor

November 13, 2019

20 Min View
Aseptic Filling for Gene Therapies and Next-Generation Biologics Within Closed Robotic Workcells

Date: Nov 13, 2019

Duration: 20 Min

This webcast features: Thomas Page, PhD, Vice President, Engineering and Asset Development, FUJIFILM Diosynth BiotechnologiesFDB-11-7-19-ATE-300x300.png

Fujifilm Diosynth Biotechnologies (FDB) sought to “close the loop” by keeping all upstream and downstream aseptic processing operations within closed systems. The missing part was downstream, where FDB implemented a closed robotic filling workcell for manufacturing gene therapies.

Workcells solve long-standing problems with sterility assurance, containment, and process control in aseptic filling. The knowledge developed by FDB during its implementation and early use of a closed workcell can benefit organizations developing new drug products.

Participants will learn about the following topics:

– Transitioning to a fully closed, robotically driven aseptic filling process

– Removing humans from the process for “touchless” filling

– Managing hazard pathways and risks to drug products

– Ensuring “closure by design” for product safety and vial integrity

Watch the recorded webcast below.

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