French dosage form solutions provider Capsugel has received authorisation from the French medicines agency Afssaps (Agence francaise de securite sanitaire des produits de sante) to produce clinical batches at its Product Development Centre in Strasbourg, France.
The Product Development Centre specialises in producing lipid-based drug delivery systems. Following the approval, it will be able to better support biotech and pharmaceutical companies who require small-scale batches of encapsulated compounds for use in clinical trials.
With this additional certification, the Capsugel Strasbourg site was recognised as being cGMP compliant for the production of lipid-based formulations, as well as powder fill-based formulations using its 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, says Capsugel.
The new clinical services complement the company's GMP commercial production capabilities at its manufacturing site in Ploeermel, France, which now has cGMP commercial production capability for the Licaps drug delivery system.
"We recognise 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 Centre. "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.
"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."