Catalent announced the initiation of Phase II clinical trials of MGB Biopharma’s lead candidate, MGB-BP-3, an orally-dosed drug targeting the eradication of Clostridium difficile-associated diarrhea (CDAD). The two companies have collaborated to accelerate the drug formulation, manufacture and distribution of the drug.
 
Catalent’s services focused on the rapid development of a new tablet formulation leveraging its clinical supply network to distribute the resultant products for use in a U.S. Phase IIa trial. Catalent streamlined activities, and ran multiple parallel processes to quickly develop a formulation to optimize this molecule and solve complex clinical trial logistics challenges, and completed the project in six months.
 
The project combined a team of experts at Catalent’s early phase development center of excellence in San Diego who performed the formulation and clinical material manufacturing, alongside clinical supply specialists at its Kansas City, MO facility and Canadian supply depot, and Gary W. Goodson, of Cornerstone Pharma Consulting LLC, a chemistry, manufacturing and controls consultant, who provided further specialist technical support.
 
"The project presented us with an incredibly challenging timeline that separate formulation and clinical supply vendors would have been unable to achieve," said Julien Meissonnier, Catalent’s vice president, Science & Technology. "By gathering our formulation, analytical and clinical supply experts under a single project team from the start, and leveraging Catalent’s common systems and processes across our drug product and clinical supply sites, our team has succeeded in ensuring that MGB Biopharma’s drug product was delivered to the first patients on time."
 
Catalent’s San Diego facility is one of three global centers of excellence in early-phase development focusing on preclinical to clinical Phase IIb formulation, analytical, and manufacturing solutions for orally delivered small molecules, the other two being located in Somerset, NJ and Nottingham, U.K. The three strategically located sites are closely connected to the company’s clinical supply services network, to help optimize the transition from finished dose manufacture to clinical packaging and distribution.

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