What Are the Correct Cold Chain Testing Standards for Your Biologic Packaging and Product Formulation?

What Are the Correct Cold Chain Testing Standards for Your Biologic Packaging and Product Formulation?

Many of the projects Modality Solutions work on for clients require thermal qualification for their packaging and shipping validation for their drug product. Often, clients request ISTA standards in thermal packaging qualification and the ASTM D4169 standard in shipping validation. Interestingly, pharmaceutical manufacturers decided to use ASTM D4169 before many of the latest GDP guidance and country-specific regulations were published.

For that reason, we are often asked the right testing approach for a client’s packaging systems, drug product formulation, and most importantly, the differences between the two. We do not recommend ASTM D4169 for transport validation, especially for clients with complex biological therapies like monoclonal antibodies or CAR-T cell therapies and their unique stability challenges.

Based on our experience with over 125 different therapies and 250 successful regulatory interactions with data collected with concurrent, multi-variate simulation testing, Modality Solutions recommends using this shipping validation methodology for your drug product. For example, a drug product identified as a high risk to both temperature extremes and shock/vibration requires a transport simulation that tests the effects of real-time intensity of shock/vibration events across the range of the extreme high and low temperatures expected in the cold chain.

This approach allows for creating a test plan tailored directly to your transport environment and the risks to your drug product. We recommend designing the simulation plan based on our know-how we have developed through years of experience in transport simulation testing. Our unique Transport Simulation Laboratory allows us to generate more robust physical and chemical stability data and achieve better results for our clients to assure patient safety and supports all accelerated designations for regulatory approval.

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