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There are many benefits associated with the use of combination products (e.g., SmartDose® and SelfDose® Drug Delivery Platforms). Since combination products are often patient centered, they are designed to be convenient, assist in maintaining a drug therapy from home, and help to enable better compliance. To ensure these benefits, developers must formulate and execute a proper design verification study to minimize impacts by unknown risks.
A risk-based design verification study should encompass both physical aspects of device component performance (in particular, how individual elements interact at interfaces), and physiochemical interactions with the drug product. Best practices in design verification studies require a detailed strategy covering design intent, including supply chain risks starting with raw materials and purchased components. Design verification strategy can be greatly enhanced by coupling with a regulatory compliance strategy. Critical components of such a strategy are a clear understanding of FDA guidance documents (e.g., 11040-4: Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4), ISO standards (e.g., 11040-8:2016: Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes) and pharmacopeia guidances (e.g., USP <1207> Package Integrity Evaluation – Sterile Products).
An especially critical component of design verification studies is the failure modes and effects analyses (FMEA), which is necessary to identify, reduce and manage design and process risks. This analysis should consider every possible risk, and be conducted by a team comprised of a trained FMEA facilitator and appropriate subject matter experts, ideally employing advanced software tools (e.g., HBM Prenscia Reliasoft® XFMEA® and PTC Windchill® FMEA) to effectively manage what are often very large amounts of critical information.
In summary, a combination product based upon a properly formulated and executed design verification study enables safe and efficient delivery of drug products to patients. A thrust area of West Analytical Services, LLC, Packaging and Device / Combination Product Testing, focuses on these issues. For more, visit the Analytical Services - Packaging and Device / Combination Product Testing section of the website.
SmartDose® and SelfDose® are trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
Reliasoft® and XFMEA® are trademarks of HBM Prenscia Inc.Windchill® is a trademark of PTC Inc.
Knowledge generation and risk reduction are goals of combination product testing. A risk-based, and standards-based, testing strategy creates not only a quality product, but ensures continuity between past and future data sets. This enables the long-term, safe and efficient delivery of drug products to patients. And time to market is improved by reducing product launch false starts.<br />
The combination product market has seen a significant amount of growth,<sup>i</sup> driven primarily by the rise in chronic disease indications, the demands for self-administered therapies and technological advancements. The use of combination products simplifies the process of drug administration for the patient and/or the caregiver and, in some cases, allows the patient to receive treatment at home rather than having to travel to a medical facility. However, there are many challenges that need to be navigated as one considers the transition from a vial system to a needle-based combination product.
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ revealed some of our customers’ biggest challenges. This is the final of our three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
Defined under US FDA 21 CFR 3.2 (e)(2), a <em>co-packaged combination product</em> consists of “two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products”. (1) These device products can range from delivery devices, to bandages, to antimicrobial swabs. Understanding the regulations around such a wide range of devices can be challenging; drug companies often look to the device manufacturer/provider for guidance when filing.
One of the increasing trends in the world of drug-device combination products is the use of platforms for drug families, delivery device technologies, and primary packaging.
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