The project presented us with an incredibly challenging timeline that separate formulation and clinical supply vendors would have been unable to achieve.
SOMERSET, N.J. (PRWEB) April 25, 2019
Catalent, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that it 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 diarrhea (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 U.S. Phase 2a trial. By streamlining activities, and running multiple parallel processes with minimal downtime, Catalent has quickly developed a superior formulation to optimize 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 center of excellence in San Diego who 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 centers 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, U.K. The three strategically located sites are closely connected to the company’s clinical supply services network, to optimize the transition from finished dose manufacture to clinical packaging and distribution.
Catalent is the leading global diversified provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With more than 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs over 11,000 people, including over 1,800 scientists, at more than 30 facilities across five continents, and in fiscal year 2018 generated approximately $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com.
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