Factors To Consider When Selecting A CDMO For Complex Injectables Development And Manufacture

Complex injectables have become a popular delivery method in acute and chronic disease treatments for small molecules and biologicals. Particularly, suspensions and lipid-based nanoparticles are being increasingly utilized due to their ability to increase drug loading to improve bioavailability/stability and enable the formulation and development of long-acting injectables for poorly soluble drugs and biologicals.

Production of early phase clinical trial materials for complex injectables, however, is a challenge. Pharmaceutical and biotechnology companies can turn to a niche contract development and manufacturing organization (CDMO) to overcome the inherent obstacles. The right CDMO partner will have specialized technologies for complex injectable development along with the equipment, facilities and operations to adopt GMP practices with a “laboratory setting.” The best-in-class will also be nimble and have greater flexibility regarding changes, timing, and cost for successful manufacture of complex injectables in early phase development of therapeutic drugs.

This article reviews complex injectable dosage form development and GMP considerations.