Finding Common Ground: Factors for Establishing and Safeguarding Shelf Life In Combination Products

For more than half a century, combination products have opened up new and more effective treatment pathways by integrating drugs into complementary delivery platforms. The first combination products, such as antibiotic-loaded bone cements and drug-eluting stents, emerged in the 1970s to lay the foundations for continued advances in materials engineering and drug delivery technology, which prompted significant market growth.1Indeed, the global annual volume of prefilled syringes alone is estimated currently at around five billion units, with this sector of the market projected to be worth more than $35.7 billion by the end of 2031.2 Where the components of drug and device come together as combination products, whether co-packaged or developed as a single entity, they can bring significant benefits to patients. This is particularly true in the face of rising chronic disease indications, with combination products either simplifying self-administration or easing the treatment burden by enabling drugs to be delivered without the intervention of a medical professional, and often in a home setting. Making these benefits a reality, however, requires manufacturers of combination products to consider and align a range of critical variables. A key area of consideration is storage and shelf life, given the fundamental requirement for a combination product to function safely, effectively and as intended when it reaches the point of use. The shelf life of a combination product can be influenced by various environmental factors including, but not limited to, humidity, light exposure and pressure. The evaluation of each environmental factor must then be considered during the combination product’s transportation, storage and use. Therefore, establishing robust shelf-life and stability studies is crucial to the combination product development process and a fundamental requirement for regulatory submissions. Shelf-life requirements are defined by global consensus standards and country-specific regulations. In the case of sterile products, container closure integrity studies will also be required to show that packaging components fulfil their responsibility of maintaining a sterile barrier, and ensuring that the product to be protected from contamination, or damage. The resulting data from those studies allows accurate labelling information to be established, defining the expiration date.

Best Practices • Shelf-Life