The CDMO has welcomed the commencement of Phase 2 clinical trials of the orally-dosed drug targeting the eradication of Clostridium difficile-associated diarrhoea (CDAD)
Global CDMO Catalent has welcomed the commencement of Phase 2 clinical trials of MGB Biopharma. The two companies have collaborated to accelerate the drug formulation, manufacture and distribution of MGB Biopharma’s leading candidate, MGB-BP-3, an orally-dosed drug targeting the eradication of Clostridium difficile-associated diarrhoea (CDAD).
Catalent’s services focused on the rapid development of a new tablet formulation and leveraged its clinical supply network to distribute the resultant products for use in a US Phase 2a trial. By streamlining activities, and running multiple parallel processes with minimal downtime, Catalent has quickly developed a superior formulation to optimise this molecule and solved complex clinical trial logistics challenges, completing the project in just six months.
The project combined a team of experts at Catalent’s early phase development centre of excellence in San Diego. They performed the formulation and clinical material manufacturing alongside clinical supply specialists at its Kansas City, Missouri 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,” commented 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 centres of excellence in early-phase development focusing on preclinical to clinical Phase 2b formulation, analytical, and manufacturing solutions for orally delivered small molecules, the other two being located in Somerset, New Jersey and Nottingham, UK. The three strategically located sites are closely connected to the company’s clinical supply services network, to optimise the transition from finished dose manufacture to clinical packaging and distribution.