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Considerations for Implementation of a New Drug Substance Container for Subzero Storage
William J Rayfield1, William S McKechnie1, Sunitha Kandula1
1Downstream Process Development and Engineering, Biologics and Vaccines, MRL, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.
Journal of Pharmaceutical Sciences
|December 28, 2020
Summary
Choosing the right biologic drug substance container is crucial for global manufacturing. This study compared CryoVault™ and CelsiusPak® containers, assessing stability and leachables to ensure product quality during transport.
Area of Science:
- Biopharmaceutical Manufacturing and Supply Chain Logistics
- Container Closure Systems for Biologics
Background:
- Globalized therapeutic manufacturing requires worldwide transportation of drug substance (DS).
- This necessitates careful consideration of container selection to mitigate risks of damage, high shipment costs, and potential impact on product quality attributes, stability, and leachables.
- Existing container options for Biologics DS vary in materials and design, each presenting unique risk profiles.
Purpose of the Study:
- To evaluate a novel CryoVault™ container against a characterized CelsiusPak® bag container for Biologics DS storage.
- To assess the impact of container design and materials on product quality attributes, stability, and leachables.
- To inform the selection of an appropriate container for implementation in the drug substance manufacturing process.
Main Methods:
- Utilized a representative scale-down model to evaluate container performance.
- Conducted an extensive data package analysis, including product stability over time and temperature.
- Assessed the impact of extractables and leachables from different containers subjected to a typical freeze/thaw cycle.
Main Results:
- Comprehensive data on product stability, extractables, and leachables were generated for both container types.
- The study provided a comparative analysis of the CryoVault™ and CelsiusPak® containers under simulated transport conditions.
- Evaluation of the extensive data package facilitated a decision regarding container implementation.
Conclusions:
- The selection of an appropriate storage container is critical for maintaining Biologics DS quality during globalized manufacturing and transportation.
- Risk assessment of container design, materials, and potential leachables is essential.
- The data generated supports informed decision-making for implementing suitable container solutions in Biologics DS manufacturing processes.
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