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Midwest Regional Forum September 2020
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Midwest Regional Forum Virtual Meeting
Wednesday and Thursday, September 9 - 10, 2020
Start Time: 10 am Central Daylight Time



Clinical (and Beyond) In-use Stability Studies – Challenges, Considerations and Case Studies

Co-Chairs: Julie Heflin, AbbVie Inc. and Thomas Schomogy, Pfizer. Inc.

Clinical in-use stability studies are required for any new parenteral drug product, whether submitting the first IND/IMPD or filing the marketing authorization application.  These studies are vital to our clinicians in the field as the studies determine the compatibility with common medical ancillaries, define storage conditions of the prepared product and demonstrate that our medicines are stable throughout the preparation and administration to our patients.  The learning objectives for this forum are:

1.  Considerations for designing phase appropriate compatibility and in-use studies

a.  Approaches for different drug product dosage types
b.  Good Scientific Practices (or R&D) studies
c.  GMP studies

2.  Microbial considerations for extemporaneous dose preparations for parenteral products

a.  Clinical considerations and when does USP <797> apply
b.  Complying with the Metcalfe study requirements
c.  Products with preservatives and complying with USP <51>
d.  Commercial considerations
e.  Leveraging platform/prior knowledge

3.  Analytical considerations for clinical in-use stability studies – what are the phase appropriate tests to perform

a.  Critical tests that should be applied always (tier 1)
b.  Additional tests that may provide useful information (tier 2)
c.  Considerations for clinical phase studies
d.  Consideration for commercial studies

4.  Analytical method challenges for low concentration in-use samples and case studies on how to overcome these challenges

a.  Approaches for Tier 1 (e.g., protein content, Phys-Chem methods)
b.  Approaches for Tier 2 (e.g., advanced characterization methods)

About the Regional Forums:

The CASSS Midwest Regional Forum is committed to bringing job-relevant education to the local biopharmaceutical and biotechnology community. These programs are dedicated to facilitating the sharing of information and best practices in order to advance scientific knowledge across industry, academia, and regulatory agencies. This virtual regional forum will feature presentations, a panel discussion, a case study and peer-to-peer learning.






Want more information? Contact CASSS at 510-428-0740 or



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