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Every pharmaceutical company wants to maximize speed to market for a new drug product. One way to enable this is with a platform approach for the package and delivery systems – in other words, to use the same vial containment system and/or syringe system for multiple drug products. To use this approach effectively, component and system performance data is needed. Through the Integrated Solutions platform, West is ideally positioned to provide this data.
Gene and cell therapies require cryo storage – approximately -80<sup>o</sup>C for genes, and approximately -180<sup>o</sup>C (i.e., vapor of liquid nitrogen) for cells. This requirement places a very high demand on the packaging to provide both good container closure integrity (CCI) and preservation of drug product viability.
West is now celebrating the one-year anniversary of its Integrated Solutions initiative, known as Simplify the Journey™. Throughout 2019, we socialized the program through marketing materials and face-to-face conversations with customers. Now it’s time to reflect on the lessons we’ve learned — and to look forward to the opportunities on the horizon.
West today announced a multi-year investment as part of the Company’s evolving research and development strategy. To better support pharmaceutical customers around the world, West will add capabilities to all of its global Packaging Systems R&D facilities, and develop two new R&D Centers of Excellence—one in the Asia Pacific region and one in Europe—to leverage regional capabilities and expertise in parenteral drug packaging.
In August 2022 the European Union revised its guidelines for sterile medicinal products for human and veterinary use. These guidelines came into effect on August 25, 2023. West has compiled the most frequently asked questions about Annex 1 and how it affects sterile drug manufacturers, which will be published across a multi-part series.
West is pleased to announce the availability of a new sterile drug vial seal, the Flip-Off<sup>®</sup> Plus<sup>RU</sup> seal. Part of West’s Flip-Off® seal product family, these new ready-to-use seals help pharmaceutical and biopharmaceutical manufacturers protect the safety and integrity of their drug products while meeting regulatory requirements for increased drug cleanliness and safety.
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