Bioreactivity testing in single-use system biomanufacturing

This webinar will give an overview of the forthcoming industry position paper that revisits the assumed need for USP (88) / Class VI for SUT.

The speakers will highlight regulatory requirements and perceived challenges to a change in testing, along with the current evidence base that demonstrates that a move away from USP (88) testing will not affect product quality or compromise patient safety.

Our speakers 🗣️
Anderson Wong, ‪@Sanofi‬
Ariana Gleisberg, ‪@thermofisher‬
James Hathcock, ‪@PallCorporation‬
Kelsey Golk, ‪@pfizer‬
Monica Cardona, ‪@milliporesigma2407‬
Nicole Hunter, ‪@WatsonMarlowUK‬
Sade Mokuolu, ‪@WatsonMarlowUK‬

Chapters:
0:00 Webinar and BioPhorum introduction
2:58 Social responsibility and bioethics
9:42 Industry consensus positions
11:10 Single-use materials qualification
17:15 Historical background of USP biological reactivity testing
20:45 USP (1031) current language
22:56 Potential roadblocks and concerns

#BioPhorum #Sustainability #SingleUse #SingleUseSystem #bioreactivity #biomanufacturing