Catalent Launches New Oral Developability Assessment & Manufacturing Solution to Advance Targeted Protein Degrader Programs

Catalent recently announced the launch of the ProteoSuite^SM Oral suite, which allows the rational selection of orally developable targeted protein degrader (TPD) candidates and their advancement into clinical trials. These emerging therapeutic modalities are typically highly potent and present novel oral bioavailability challenges to formulators.

The new ProteoSuite Oral platform leverages Catalent’s successful 90-year track record of advancing thousands of complex molecules for oral drug development, including experience with multiple protein degrader programs, together with the development of custom TPD-specific assays and physiologically based pharmacokinetic (PBPK) and developability models. Customers using the service will benefit from the identification of those orally developable drug candidates with the greatest chance of success, and a development path to the clinic with consideration of the necessary advanced formulation technologies such as lipid-based delivery and amorphous solid dispersions, as well as manufacturing, specialty handling, and integrated clinical supply capabilities to accommodate these highly potent molecules.

Targeted protein degraders show significant promise in therapeutic areas such as oncology and beyond, but because of their complex structures, and physico-chemical properties, achieving satisfactory oral exposure can be challenging. They also present additional formulation and handling challenges.

“Targeted protein degraders have the potential to revolutionize new small molecule therapies, but if they are to be successful oral treatments, they require a rational approach to development and a comprehensive toolkit of proven technologies to address their ‘not so small’ characteristics and potency,” said Julien Meissonnier, Catalent’s Vice President and Chief Scientific Officer. “This new service provides customers with a logical and comprehensive development path, access to Catalent’s multi-center manufacturing capabilities designed to handle highly potent compounds, and its experience in scaling up and advancing successful products to market.”

Catalent’s network of early phase development sites includes facilities in St. Petersburg, Florida, San Diego, and Somerset, NJ, in the US, as well as Nottingham, UK, and Beinheim, France. Development of targeted protein degraders at these sites will be supported by analytical, scale up and commercial sites with specific capabilities in handling potent drug products in Greenville, NC, Kansas City, MO, Winchester, KY, St. Petersburg, Beinheim, and Schorndorf and Eberbach in Germany.

Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.

Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply around 80 billion doses of nearly 8,000 products annually. Catalent’s expert workforce of approximately 18,000 includes more than 3,000 scientists and technicians. Headquartered in Somerset, NJ, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information, visit www.catalent.com.