Capsugel Receives Authorization in France for Clinical Manufacture
Strasbourg, France: Capsugel, a leading provider of dosage form solutions to the pharmaceutical and related healthcare industries, announced that it has received authorization from the Agence française de sécurité sanitaire des produits de santé (Afssaps) to produce clinical batches at its Product Development Center in Strasbourg, France. This will allow the Product Development Center to better support biotech and pharmaceutical companies who require small-scale batches of encapsulated compounds for use in clinical trials.
The Product Development Center in Strasbourg has successfully offered pre-clinical formulation services for 10 years, and specializes in producing lipid based drug delivery systems. Now, this center can offer a wider array of clinical program services, form formulation development all the way through cGMP compliant production of clinical batches.
Both of Capsugel's Product Development Centers (the Strasbourg site as well as the newly-opened laboratory in Boston, Mass., USA) benefit from having a team of expert chemists, pharmacists and engineers with extensive experience in pharmaceutical formulation, analytical development, and process technology.
With this additional certification, the Capsugel Strasbourg site was recognized as having put in place all of the quality systems required to become cGMP compliant for the production of lipid based formulations, as well as powder fill based formulations using Capsugel’s Xcelodose® Precision Powder Micro-dosing System. This makes the facility ideal for pharmaceutical companies looking to outsource production of their clinical batches for early stage clinical trials.
The new clinical services offered by the Product Development Center perfectly complement Capsugel’s GMP commercial production capabilities at its manufacturing site in Plöermel, France, which now has cGMP commercial production capability for the Licaps® Drug Delivery System.
“We recognize that many companies, and especially small biotechs, are often under intense time pressure to have what is sometimes their only lead product available for Phase I testing as soon as possible,” said Dr. Jan Vertommen, Director of the Strasbourg Product Development Center. “However, many do not have the time or resources to invest in additional equipment or to develop in-house formulation strategies for poorly soluble compounds. Additionally, most would prefer to use the same manufacturer to produce their pre-clinical and clinical batches, as this saves time when doing audits or technology transfers.”
Dr. Vertommen added, “This is why we are delighted to respond to these needs by offering clinical trial production capability from our Strasbourg Product Development Center. With our expertise in developing and processing lipid based formulations, we are confident that we can promptly deliver clinical batches within weeks of receiving all the necessary official documentation.”