Dear community members,
Please join us for a webinar on "Cold Chain and Transport Validation of Complex Biologic Modalities".
This webinar is organized by the Sterile Products Community and the Protein Purification, Storage, Transportation and Drug-Device Combination Community.
Join us for a webinar on cold chain and transport validation of complex biologic modalities, with Gary Hutchinson, president of Modality Solutions, and Robert Battista, Engineering Manager for Modality Solutions. This webinar will focus on how to successfully integrate and validate your biopharmaceutical cold chain for complex biologics. We will present practical insights and strategies to better define your operating space, demonstrate drug product robustness with transport simulation and analytical testing, and align your drug formulation testing with your performance qualification to validate your shipping lanes.
Defining your operating space for drug product requires defining your risks in a formal assessment, understanding the hazards in the distribution network, and combing these two elements into a robust transport simulation test. Coupled with targeted analytical testing, this approach is the most effective and efficient drug formulation testing approach and is considered by many to be an industry best practice.
ASTM D4169 testing is not enough to ensure compliance and safe patient outcomes with complex biologics. Learn an approach that has been proven with regulatory agencies worldwide with over 80+ successful filings in the last four years.
Learning Objectives:
- Design transportation and cold chain validation for your complex biologics
- Design and perform studies in collaboration with a diverse group of biopharmaceutical scientists and engineers
- Understand critical regulatory requirements for cold chain validation
Link for registration:
\https://www.pathlms.com/aaps/webinars/35310
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Hiten Gutka
Vice Chair Sterile Products Community
Senior Principal Scientist Drug Product Development
Bristol Myers Squibb
New Brunswick NJ
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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