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The combination product market has seen steady growth,ⁱ driven primarily by the rise in chronic disease indications, the demands for self-administered therapies and technological advancements in drug-delivery devices. Drug- or biologic-led combination products are typically a pharmaceutical product pre-packaged in a device that can be used for administration. 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, thus easing the burden on patients and helping facilitate drug regimen adherence. 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.

Today, we celebrate Global Recycling Day, and the vital role recycling material plays in securing the future of our planet. Our One West Team is dedicated to finding innovative solutions that reduce waste and promote a circular economy. Eliminating waste is a key sustainability priority for West, and our initiatives demonstrate our commitment to tackling climate challenges while meeting the expectations of our key stakeholders.

When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose. Numerous international standardsⁱ and pharmacopeial chaptersⁱⁱ focus on functional performance testing and they all recommend conducting tests that simulate real-world conditions based on the intended use of the device or packaging. This simulation includes matching the physical properties of the drug when using placebos, duplicating the number of punctures and the expected needle size that would be encountered in actual practice and testing samples that had been conditioned with the appropriate sterilization treatments, transportation simulations, storage conditions and thermal exposure to approximate actual expected sample environmental exposure which might affect performance.

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.

In 21 CFR 211.94 it is stated that “Drug product containers and closures shall not be reactive, additive, or absorptive to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.” While the code makes this statement, and if expanded on in the related FDA Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics (May 1999), there is no prescription offered in how to execute an extractables and leachables evaluation, which is, of course, an essential aspect of demonstrating suitability of container closure systems.