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2020 ISPE Annual Meeting & Expo


NA20CENOV1/SES212 - Rapid Biological Facility Development


Nov 4, 2020 1:00pm ‐ Nov 4, 2020 2:30pm

Description

Rapid Biological Facility Development | Vaccine and drug products that are being supplied to the developing world can take advantage of BFS technology that has been developed for high efficiency and quality, and low-cost drug production. In order to test these biological products, it was necessary to have a facility that would allow safe product testing. Rommelag CMO (Zell, Switzerland) installed the first BFS technology into a BSL-2 rated facility to provide a place to test biological products in 2012. The high automation level, high aseptic assurance, low intrinsic and extrinsic particle load found in the containers has increased interest in BFS technology for vaccines and other biological products. This case study will cover the various vaccines and biotech products that have been tested in this special facility. Topics covered will be plastic material compatibility, special procedures necessary for a multi-product facility, and the ability to scale BFS applications to very and fast production likes with pandemic applications.

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