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The development of drug delivery devices that are innovative, intuitive, and patient friendly must address certain areas of concern that are particular to both biologic and biosimilar therapies. Learn what it takes to develop discreet, frictionless systems that improve patient outcomes.
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Manufacturing planning is a critical step in the commercialization path and helps accelerate the path to market. Obtaining information and proactively mapping out your strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.
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Ready to improve your submission success rate? Achieving a "right first time" regulatory submission is essential for ensuring product accessibility. Learn how early cross-functional collaboration and a strategic approach streamline compliance for faster market access.
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Auto-injectors simplify the process of at-home drug administration, yet rigorous testing is essential. Meeting requirements for cap removal force, activation force, injection time, and dose accuracy is key to ensuring safe, reliable, and effective drug administration for patients.
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Establishing combination product shelf life requires aligning the stability of the drug, device, and packaging to meet strict global regulatory standards. Holistic, data-driven stability studies are crucial to ensuring product function, safety, and label claims through the entire supply chain.
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Developing combination drug-device products is a complex process involving device selection/design, manufacturing, regulatory strategy, fill/finish of the drug into a cartridge or prefilled syringe, assembly of the drug product and device, labeling, packaging, testing, serialization, lifecycle strategy, etc. The links above call out key considerations across these steps and identify ways in which West Pharmaceuticals supports pharmaceutical and biotechnology companies in their combination product journey.
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