Capsugel has received authorisation from the Agence francaise de securite sanitaire des produits de sante (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 centre can now offer a wider array of clinical programme services, form formulation development to cGMP compliant production of clinical batches.
The Capsugel Strasbourg site was recognised 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 suitable for pharmaceutical companies looking to outsource production of their clinical batches for early-stage clinical trials.
