Formulation Through Manufacturing Under One Roof: One Emerging Biopharma's Experience

Emerging biopharmas (EBPs) often operate with limited or fluctuating financial resources, requiring them to maintain lean teams focused on subject matter expertise. As a result, they may lack direct access to manufacturing capabilities or have limited knowledge in selecting and optimizing product formulations and presentations, such as vials, syringes, or auto-injectors. Additionally, navigating the complex regulatory landscape of drug development can be challenging. To overcome these hurdles, EBPs require a CDMO partner that provides strategic guidance and technical expertise throughout the development process.

Recognizing these needs, Catalent offers tailored formulation development and integrated manufacturing services designed to support EBPs in bringing their therapies to market. One such collaboration began in 2022 when a company sought Catalent’s expertise to formulate a peptide treatment for a rare endocrine disease. While the client valued the seamless, end-to-end service model, the success of the fill/finish process for clinical batches depended on the success of formulation development. The project was conducted at Catalent’s Limoges, France, site—its European Center of Excellence for clinical biologics development and drug product fill/finish. Within a year, engineering batches were successfully produced, and plans for clinical batch production are already underway, demonstrating the efficiency and reliability of Catalent’s comprehensive approach.