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West is pleased to welcome guest blogger and valued corporate partner The American Red Cross

Annex 1 of the European Union’s Good Manufacturing Practice guidelines (EU GMP Annex 1) has loomed large over the manufacture of parenteral products since it was first introduced in August 2022.

At West, safety is more than just a priority - it’s a core part of how we work together to protect and support one another. As we mark the World Day for Safety and Health at Work, we are proud to shine the spotlight on our Sri City team, whose commitment to creating a safe and healthy workplace has earned them well-deserved recognition.

The landscape of drug delivery systems is rapidly evolving, with wearable devices and autoinjectors at the forefront, offering patients greater convenience and autonomy in managing chronic conditions. A key design consideration with such devices is whether the drug container comes preloaded with the device or is user-loaded. This article explores the strategic advantages of user-loaded designs, emphasizing the benefits of separating the drug from the device, enhancing patient safety and usability, and minimizing the costly waste of expensive medications.

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.

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.