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Formulation Development Success Story

Formulation Development Success Story: Uric Acid Treatment Approved by FDA

The U.S. Food and Drug Administration recently approved a new uric acid treatment that was developed as a partnership between Metrics Contract Services and the project sponsor.

The drug can be used to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body.

Anshul Gupte, Ph.D., associate director of pharmaceutical development at MCS, was the primary technical and project leader who was involved with the drug’s development. The project came to MCS about six years ago when it was in late Phase I/early Phase II clinical trials. The client was managing multiple changes in the development/clinical timeline and its active pharmaceutical ingredient (API) — as all companies do at that stage of drug development. The client needed a contract development and manufacturing organization (CDMO) partner that was technically savvy, collaborative, flexible and reliable, Gupte said.

“During those six years, MCS developed numerous prototypes of the product at multiple strengths,” Gupte said. “MCS provided development and manufacturing support and produced the clinical trial supplies throughout the Phase II and large Phase III trials. In order to accommodate the clinical requirements, we scaled up the formulation from 1 kg to 400 kg batch size. This was largely done while the product was still being manufactured under GMP, as API supply was limited along the way. MCS conducted Quality by Design-style studies at various scales in association with the sponsor.”

In addition to the sponsor, MCS worked with consultants, subject matter experts, drug substance manufacturers and packaging companies on this project, Gupte said.

“We truly started small scale and increasingly produced more material as the company’s clinical trials grew,” he said. “Our team was able to keep up with changes and deliver high quality and reproducible drug product into the clinical setting.

“You know you have done a good job when the sponsor considers you to be an extension of their company, and when the relationships you develop with the sponsor over the long drug development timeframe are rewarding,” Gupte added.

The drug was Gupte’s first compound to be approved by the FDA for commercial production.

“When a drug product is approved, it’s really very exciting,” he said. “It’s incredible to know that you played an important part in developing a new treatment that will help patients.”