A Risk-Based Approach To The Development Of An Injectable Combination Product

By Fran DeGrazio, former Chief Scientific Officer, Diane Paskiet, Director Scientific Affairs, and Peggy Frandolig, Sr. Manager Scientific Affairs, West Pharmaceutical Services, Inc.

Drug-device combination products (DDCPs), such as injectables, can consist of a biological product and a device, a drug and a biological product, or a drug, device, and a biological product or simply a drug and a device. DDCPs leverage new technologies that provide many advantages for patients, such as self-administration conveniences and safety, and, for payers, improved adherence. However, DDCPs are complex and challenging to develop.

This white paper examines how to establish a holistic approach to DDCP development and how to assess and manage risk throughout the development and approval process.