How To Pick The Right CDMO For Late-Phase Clinical Trials

By Christy Eatmon, Global SME, Sterile Drug Products, Thermo Fisher Scientific

For pharmaceutical companies without their own facilities, choosing the right partner for late-phase clinical trials and commercial production is a critical consideration in developing parenteral products. Small contract development and manufacturing organizations (CDMOs) can often provide early-phase material but may not always be able to move through to meet the rigorous demands of late stage and into commercialization. This article examines some of the key criteria for selecting the right CDMO partner and includes a case study that shares some challenges involved in a late-phase technology transfer for a parenteral product.