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Clinical batch authorization.

Capsugel (www.capsugel.com) has received authorization from AFSSAPS (the Agence Frangaise de Securite Sanitaire des Produits de Sante) 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 has successfully offered preclinical formulation services for 10 years and specializes in producing lipid-based drug delivery systems. Now, this centre can offer a wider array of clinical programme services, from formulation development to the cGMP-compliant production of clinical batches. 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 Microdosing 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 complement Capsugel's GMP commercial production capabilities at its manufacturing site in Plbermel, France, which now has cGMP commercial production capability for the Licaps Drug Delivery System. "We recognize that many companies, 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 preclinical and clinical batches, as this saves time when doing audits or technology transfers. 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."

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Title Annotation:CPhI news
Publication:Pharma
Date:Nov 1, 2009
Words:337
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