Combination product development is an inherently complex endeavor involving drug and delivery device manufacturing under immaculate conditions, shipping and distribution under temperature-controlled conditions, and delivery to medical facilities, pharmacies and ultimately to the patient. Many aspects of drug development and manufacturing can affect the final form and function of a combination product. This presentation describes a holistic strategy that is titled “deliverability assessment,” which can be used to examine the entire development pathway of a combination product from manufacturing to patient use. This mentality of beginning-to-end coverage aids in foreseeing and solving problems across the lifecycle of combination products, particularly at the interface between drug and device, which can present conflicting requirements.
Learning Objectives:
The complexity of combination product development requires integrated, systematic thinking to map out potential risk factors in drug product, delivery device and injection physiology, which can help reduce the occurrence of drug device interface issues in drug stability, device performance and patient experience.
This deliverability assessment needs to occur early in the development cycle, in parallel with drug development, and reiterate upon new data and refinement of design requirements. .
This approach is applicable to combination products containing all drug modalities including proteins, peptides, oligonucleotides, etc.
