High Potent Formulation Development In Oncology

By Louise Carpenter, Head of Formulation Development, PCI Pharma Services

Originally published in Contract Pharma April 2023.

Targeted therapies and precision medicines have revolutionized cancer treatment, resulting in more effective and potentially less toxic therapeutic options for patients. As a result, demand for the development and manufacture of drug products containing highly potent active pharmaceutical ingredients (HPAPIs) is on the rise. Accelerated approval pathways from regulatory agencies including the FDA are fostering innovation and promoting faster commercialization of these novel oncology drugs.

The increased demand for these products and growing pressure to speed to market places formulation development in an even more critical role, as it ensures the successful translation of these breakthrough discoveries into safe, effective, and accessible drug products for patients, while ensuring a greater speed to market for sponsor organizations.

Unrealistic or aggressive timelines may create problems during later stages of development and scale-up, potentially compromising the overall success of the project, as more formulation development may inevitably be required at a later, more time-critical stage. Establishing a strategic partnership with a trusted CDMO during the development stage can help mitigate risk while achieving speed to patient, study, approval, and commercial launch. Examine the vital role formulation development plays in the rapidly growing field of oncology outsourcing and how sponsors can increase their chances of success with the right CDMO partner.