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At some point early in the development of a drug product, pharmaceutical manufacturers must make a very important choice. How will the final product be delivered to the patient? That choice leads to a variety of additional choices regarding drug formulations, stability, container closure systems and the various interactions of the drug with its packaging, and ultimately, patient compliance.
The use of medical devices in combination products has increased greatly in the past 15 years and is expected to continue to increase for the foreseeable future. This has been bolstered by an industry push to fill a demand for patients to have access to at-home therapies with the use of self-dosing and on-body wearable solutions. Companies that decide to use devices like these to deliver their drugs have plenty to consider with regards to extractables, leachables, and the overall chemical safety of their product. A strong understanding of the risks that leachables may pose during the use of a combination product first requires thoughtful and informed design of extractables studies as part of chemical characterization of both the device and container closure system, with the appropriate application of industry guidance.
Don’t miss an opportunity to meet with West experts at an upcoming tradeshow! Stop by our booth or one of our presentations to learn more about how West can help address common industry challenges with drug product packaging and delivery.
Administration of cell therapy drug products requires the delivery of cell suspensions without loss of function or viability. Cells must be transferred aseptically from their original container closure system to the administration system by infusion. However, the common transfer practice of using needles and syringes to pierce vial stoppers to retrieve contents poses a risk, namely needle-stick injury to clinicians.
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