Cold Chain Validation Best Practices, Including Immunotherapy

Written By Kelsey Bailey

Cold chain validation is one of the most challenging aspects of biopharma development, especially for advanced therapies like immunotherapies. This 45-minute webinar explores proven approaches to qualifying shipping lanes, testing packaging systems, and meeting evolving regulatory expectations.

Key topics include:

  • Establishing robust stability data and testing for environmental hazards during transport

  • Qualifying transport lanes using Operational and Performance Qualification approaches

  • Why ASTM D4169 alone isn’t enough—understanding drug product vs. packaging qualification

  • Special considerations for immunotherapies such as ADCs and T-cell therapies, where cold chain risks are amplified

  • Pulling it all together for filing and inspection with confidence

Watch the session to learn how to strengthen your validation program and reduce regulatory risk across complex supply chains.

Kelsey Bailey
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