Executive summary

Changing delivery formats for sterile injectable therapies can be a valuable strategy for effectively managing the lifecycle of a drug. Depending on the specific circumstances, switching formats can help bring a drug to market more quickly, make a drug usable in more situations, provide cost efficiencies for the supplier, and ease medication administration to patients. For example, a growing number of suppliers of biologics are moving their products from bulk glass vials to prefilled syringes due to the ease of use and convenience syringes offer, as well as their ability to eliminate dosing errors and, thus, improve patient safety. With a prefilled syringe, medications can be delivered directly and immediately to the patient, whereas vials require multiple steps prior to injection—flipping the dust cover, cleaning the stopper surface, prepping a syringe, withdrawing the medication, and checking the dose in the syringe—all of which take extra time and introduce opportunity for error. Several factors must be considered before switching delivery formats, however. These include technical considerations, process and cost implications, supply chain requirements, regulatory requirements, and lead times. A successful transition also requires a thorough understanding of the physicochemical properties of the molecule, the potential interactions with device components, and the impact of formulation and process variables on product stability and quality. This report provides insight into the benefits and challenges of transferring a therapeutic compound from one injectable format to another, focusing specifically on the following:

•  The material and process information and data needed to inform decision-making
•  The technical and analytical requirements for ensuring product integrity
•  The regulatory and timeline considerations for commercializing the product