Catalent is set to launch its new OneBio Suite for the integrated development, manufacturing, and clinical supply of biologic drugs.
OneBio has been designed specifically to address the challenges facing biologic development companies that are looking to accelerate programs to clinic or market, or that require greater simplicity in the development process, including fewer internal resource needs and a reduced risk of rework. As a single, integrated provider, Catalent Biologics’ OneBio Suite will aim to reduce timelines, risk and complexity by providing customers with a single contract, program manager, and development timeline from cell line to clinical supply with harmonized quality systems. The OneBio Suite draws upon Catalent’s proven track record of progressing biologic drugs to market, which includes over 115 global clinical trials and 11 commercially marketed monoclonal antibodies using the company’s GPEx® cell line development technology, and 20 approved products through fill/finish and commercial supply to global markets.
“Time is often lost for sponsors on the path to clinic from contract negotiation, site inspections, handoffs, and poor communication between multiple vendors,” said Bernie Clark, Vice President, Marketing & Strategy, Catalent Biologics & Specialty Drug Delivery. “Through our new OneBio Suite, Catalent is uniquely positioned to provide an integrated offering that can accelerate biologic development potentially shaving weeks to months off standard timelines and allowing our customers to get to clinic and market faster.”