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French say ‘oui’ to U.K.’s NextPharma
SURREY, U.K.—NextPharma Technologies, a leading European provider of product development, contract manufacturing and cold-chain and logistics outsourcing services to the pharmaceutical and biotechnology industries, received approval in early March by the French Ministry of Research to carry out R&D activities for French companies at NextPharma's Sterile Product Development Center in Belgium. This approval enables companies subject to corporate tax in France to claim tax credits for work subcontracted to NextPharma.
The product which was key to the accreditation, according to Sean Marett, managing director of product development services at NextPharma, is an anhydrous, highly viscous, lipid-based pharmaceutical formulation which will be tested for its efficacy in clinical trials. Such a formulation enables sustained release of the drug after administration. The product will be manufactured in prefilled syringes for clinical trials.
"Aseptic manufacturing of such a product is challenging," Marett says, "and requires innovative and advanced manufacturing solutions, which is what NextPharma is providing, and these were key to the accreditation."
Accreditation is awarded by the French Ministry of Research to companies that have demonstrated "originality or substantial improvement" in the creation or improvement of a product or process and is an official recognition of NextPharma's capabilities in that regard. NextPharma 's submission was granted approval via a document review, a key element of which was a dossier summarizing background capabilities, know-how and technologies, a detailed description of the R&D project itself and how NextPharma was going to apply its technologies and know-how to manufacture the product. A summary of the profile and experience of the managerial staff was also submitted.
NextPharma operates globally with seven centers of excellence in Europe and North America. Its services include preformulation studies; formulation development; design; development and optimization of lyophilization cycle; manufacturing for clinical trial materials; analytical and microbiological testing; clinical trial labeling and kitting; stability testing according to ICH guidelines; and regulatory support and product dossier development and registration.
"France is a very important market for NextPharma, and we already undertake work for a significant number of French customers across our sites," Marett says. "The accreditation that we have received from the French Ministry of Research is another step in our growth strategy for the French market. In addition, we have a liquids and suppositories formulation development and manufacturing center of excellence based just outside Paris. The location is a particularly attractive for those French customers who are looking for local liquids and suppository formulation development, analytical testing and manufacturing, and provides NextPharma with a springboard for further penetration of the French market."
In San Diego, NextPharma focuses on manufacturing of aseptic investigational medicinal products (both biologics and small molecules) for clinical trials.
"We label the products (including randomization and double-blind labeling), we store the products in temperature-controlled conditions and we ship to clinical centers as requested by our customers," Marett says. "We also undertake device manufacturing to commercial scale and are ISO 13485:2003 certified. The clinical trials labeling service mirrors our existing clinical trial services capabilities available at our Gˆttingen, Germany, facility. With the expected FDA approval of three of our European manufacturing facilities in the next 12 months, plus our existing business in the United States, we are planning for significant growth in the U.S. market."
Founded a decade ago, NextPharma employs 1,200 and is a global outsourcing partner to the pharmaceutical and biotechnology industry with seven product development centers, seven manufacturing plants and six temperature controlled storage and distribution sites supplying customers in North America, Europe and Japan.