Sterile injectable programs can get much harder to manage as they move closer to Phase 3 and commercial production. Sponsors are often dealing with tighter capacity, longer lead times, more complex regulatory requirements, and the need to make sure their manufacturing partner has the right infrastructure and technical experience in place.
In this Pharma Matters Q&A, Ryan Downey, Vice President of Technical Operations at August Bioservices, discusses what sponsors should look for in a late-stage sterile injectable CDMO. He examines the impact of Annex 1, growing demand from GLP-1 and other high-volume therapies, the importance of integrated technical capabilities, and why selecting the right manufacturing partner early can help reduce risk as a program approaches commercial launch.
Contract Pharma: How would you describe the current sterile injectable CDMO landscape, especially for companies moving into Phase 3 or commercial manufacturing?
Ryan Downey: Today’s CDMO landscape is evolving rapidly as the industry responds to growing demand for sterile injectable manufacturing, specialized expertise, and facilities designed to meet Annex 1 requirements. At the same time, demand to re-shore pharmaceutical manufacturing to the U.S. are increasing for the limited CDMO capacity currently available domestically.
As a result, CDMOs that invested in Annex 1-compliant equipment and facility infrastructure two to three years ago are now in the strongest position to support late-stage clinical and commercial programs. These organizations are better equipped to help sponsors of innovative therapies accelerate…
