Collaboration Beats Compromise in Combination Product Development
Combination product design and development, and the decision making surrounding these processes, is complex. Early collaborations between CDMO’s and their manufacturing partners is an effective means of managing this complexity. However, the best collaborations seek to develop a common understanding of program risks, technical risks, decision-making processes, who decision-makers are, a common language for the design and development, and a common vision for the program. These collaborations work to identify potential commercial manufacturing risks, and then address them during product development, to reduce overall risk during product launch. This effort maximizes the opportunity to successfully and efficiently manufacture combination products that are compliant with FDA 21 CFR, or other relevant regulatory standards, including 210/211 for drug handling. We will explore an effective collaborative model for combination design and development, and how we leverage this model to bring complex products, including combination products, to market in a timely manner, without sacrificing product quality.