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To mitigate risks and adapt to the industry's changing needs, the owners of co-packaged combination products must consider collaboration as a primary strategy. If devices are integral to positive patient outcomes, then device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way. |
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Vial adapters play a critical role in ensuring accurate dosing while preserving stability and integrity. Review considerations when choosing a vial adapter for cell and gene therapy drug products and a case study where West Swabable Vial Adapter™ transfer devices have been used to extract lentiviruses from a vial containment system. |
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This blog primarily addresses combination products classified as single entity or co-packaged where the applicant either has a drug or biologic packaged in a vial and seeks to expand to a combination product or has a drug or biologic that they are considering whether to package in a vial or in a combination product. See how to overcome challenges. |
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Developing a combination product can be a complex process, and discovering incompatibilities late can lead to significant setbacks. To avoid these costly delays, it's crucial to evaluate your system's performance and compatibility early in development. You’ll make go/no-go decisions earlier and prevent bottlenecks, rework, and delays. |
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Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. To address this, West has evaluated the suitability of its needle-free polycarbonate Vial Adapter™ transfer devices for withdrawing contents from vials from both a compatibility and performance standpoint. |
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Due to their dual nature, on-body delivery systems (OBDS) must comply with both medical device and pharmaceutical regulatory standards, presenting an inherent complexity for developers. This webinar explores the crucial regulatory requirements involved in the development and approval of these combination products and aims to navigate stakeholders through the regulatory landscape to facilitate successful approval. |
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