The topic that is planned for discussion in our May meeting is "In-Use Stability" and we would like to gauge areas of interest from the community to enable a robust discussion in the 60 min that we have available. We have some topics listed below to get you thinking. Please send any questions you may have on the following (or any other) topics so we can prepare ahead of the meeting.
- Biologics vs Small Molecule in-use stability study design
- Hold time/conditions, microbial study, photostability (light protected IV bag)
- Compatability: Materials/components; degradation, leachable/extractables
- # of batches: 1 for clinical development? Minimum two for commercial; Aged or not
- Choice of attributes tested: risk-based? ; physical, chemical and microbiological
- Methods: phase appropriate/ fit for purpose or validated; same as stability methods?
Sherilyn and Dan
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Sherilyn Campie
Director, Quality Control Stability
Coherus Biosciences
Foster City CA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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