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3P Biopharmaceuticals
11/04/2011
RED RED
3P Biopharmaceuticals inspected by the AEMPS to obtain the certificate of GMP compliance
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3P Biopharmaceuticals inspected by the AEMPS to obtain the certificate of GMP compliance
The biotech manufacturer hopes to broaden the scope of its authorization as a manufacturer of active pharmaceutical ingredients obtained in 2009
 
3P Biopharmaceuticals was visited this past September by inspectors from AEMPS, the Spanish Agency for Medicines and Health Products as part of the process to obtain GMP certification (Good Manufacturing Practices / Good Manufacturing Standards) for the following activities: manufacturer of commercial and biological active substances in research and implementation of quality control, batch release of drugs in research and commercial drugs.
Once the inspection has been passed, 3P Biopharmaceuticals will become the first Spanish CMO (Contract Manufacturing Organization) to obtain GMP certification. The company is dedicated to the development and production of biological and cellular therapy products.
Another inspection of the Spanish Agency of medicines and health products to expand the scope of the authorization to include the area of therapies advanced in the current authorization of 3P Biopharmaceuticals is scheduled for later this year. The area of advanced therapies in 3P consists of four scientists currently working on the manufacture of an engineered tissue product for the treatment of Vitiligo, and in several R+D projects for the generation of intermediate projects in the areas of cellular therapy and tissue engineering.
 
 
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