How the AT-Closed Vial® ensures safe cryopreservation of novel therapies
Importance of Container Closure Integrity and the Regulatory Environment
The container system is subject to qualification with a view to demonstrate how its different components react and interact during its complete life-cycle. In case of cell and gene therapies, it understands the storage at -80°C and at cryogenic temperatures. Therefore, the selected test shall be capable of validating, in a deterministic way (i.e. methods that follow a predictable chain of events and can be controlled), how the container system behaves during the storage, while generating science based CCI data.Over the years, the Regulatory bodies around the world have emphasized that CCI as a critical quality parameter for sterility and stability of the product.
The suitability of primary packaging materials should be ensured having regard to the characteristics of the product and the storage conditions. For production of authorized Advanced Therapies Medicinal Product (ATMP), selection, qualification, approval and maintenance of suppliers of primary packaging materials should be documented. maintenance of suppliers of primary packaging materials should be documented. ATMPs should be suitably packaged to maintain the quality of the product during storage, handling, and shipping. Particular attention should be paid to the closure of containers so as to ensure the integrity and quality of the product.
About Aseptic Technologies S.A.
Aseptic Technologies, part of SKAN Group, is a globally acting developer and manufacturer of fill and finish solutions for novel biotechnology products.
Within last 10 years, AT has accompanied over three hundred sponsors in the cell and gene therapy field, contributing to their scaling-out or scaling-up manufacturing strategy either in-house or transferred to a third party, gaining a tremendous experience in derisking of the process and providing absolute resistance of the filled vials during cryopreservation.
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