MORRISTOWN, N.J.—Capsugel, whose 2,800 hundred staffersproduce more than 180 billion capsules per year, and Quotient Clinical, acontract research organization (CRO) that specializes in early-stage drugdevelopment services, have joined forces in an effort to provide rapiddevelopment and clinical assessment of lipid-based formulations.
Together, the companies will use their technology andexpertise to address the drug delivery challenges of poorly soluble moleculeswith limited oral bioavailability. With up to 70 percent of the industry'sdevelopment pipeline consisting of molecules with poor solubility, thecollaboration will fast-track the effective clinical evaluation of lipid-baseddrug delivery systems in man, while optimizing the drug product for downstreamdevelopment.
The collaboration came about, notes Capsugel's senior vicepresident of R&D, Keith Hutchison, when Quotient contacted his companyabout using Capsugel's CFS liquid filling and sealing technology—a benchtoppiece of equipment that delivers about 1,000 capsules an hour—for clinicaltrials. In the process, Quotient and Capsugel found out they had both worked onthe same project for a third party. From there, it was simple to proceed to thenext step and integrate Quotient's RapidFACT real-time clinical manufacture andtesting service with Capsugel's lipid-based formulation expertise andmanufacturing capability. As part of the collaboration, Quotient will utilizeCapsugel's CFS liquid capsule filling and sealing technology at its facility inNottingham, U.K., and will be able to access the formulation expertise inCapsugel's Development Centre in Strasbourg, France.
Mark Egerton, managing director of Quotient Clinical, pointsout that while the collaboration will help customers address prevalent drugdelivery challenges for poorly soluble compounds in a more effective way, itwill also "further empower our RapidFACT service by ensuring that selected drugproducts can be rapidly scaled-up and transitioned into downstreamdevelopment—further reducing timelines to critical development milestones."
Capsugel's expertise with poorly soluble drugs includesproprietary predictive modeling technology based on an extensive database oflipid formulations built over the past 10 years that allows company researchersto find the best formulas quickly.
"We use a varietyof proprietary technologies and sophisticated tools such as the Lipidex ExpertSystem—a database of proprietary formulation data aggregated and modeled—tostreamline and support all aspects of the development or re-formulationprocess," Hutchison states. "We use the data in a rational way topredict what will happen upon dissolution, based on our accumulated knowledgeof excipients, surfactants, lipids themselves and how they react in an aqueousmedium.
"We also have a deep knowledge of capsules," Hutchinsoncontinues, "and our Licaps liquid filling and sealing technology helps speed upthe development process. These are perfect complements to Quotient's ability toaccelerate the generation of human clinical data, and we look forward tooffering the new service to our global customers."
In April 2011, Pfizer sold the Capsugel business toinvestment firm Kohlberg Kravis Roberts for approximately $2.4 billion in cash.At that time, Pfizer lowered its sales targets for 2011 and 2012 to reflect theloss of around $750 million in revenue that Capsugel generated in 2010.
Quotient Clinical is part of Quotient Bioresearch and hasmore than 20 years experience providing early drug development solutions topharmas and biotechs worldwide. Its clients include 17 of the top 20pharmaceutical companies, to whom it provides an array services includingclinical pharmacology, drug product optimization and 14C enabled drugdevelopment.
