Has anyone received agency feedback to include pre-filled syringe break loose and extrusion force tests on clinical / commercial release and/or stability monitoring? This would be in addition to the initial break loose and extrusion force testing performed during device aging and functionality studies.
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Dan Willingmyre
Vir Biotechnology, Inc.
Associate Director, Stability & Data Analytics
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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