FDA APPROVAL

RICHTER-HELM obtained FDA Approval for comercial production of a therapeutic recombinant protein RICHTER-HELM, a full-service biopharmaceutical contract development and manufacturing organization, announced today that the U.S. Food and Drug Administration has approved two Richter-Helm facilities in Hamburg and at Bovenau (to the north of Hamburg,) for commercial production of a therapeutic recombinant protein. Richter-Helm has signed an agreement with a leading international pharmaceutical company for long-term worldwide market supply of this recombinant protein, manufactured in E. coli. The terms of the commercial supply agreement have not been disclosed. Richter-Helm services covered the entire sequence of project steps starting with strain development and cell banking back in 2001, through GMP manufacturing of clinical trial material (Phase I, II, III) and process validation. Richter-Helm declared: "This FDA approval is an important milestone for our company and shows the trust and close relations between our customer and ourselves, which is the result of many years' cooperation on this ambitious development project. Our commitment to the project is clear from the way our multidisciplinary team has accompanied the product’s development from bench to market." Please feel free to meet us at: BioTalk Manufacturing Excellence Berlin, Germany, September 26 - 27 CPhI / ICSE in Frankfurt, Germany (booth 3.1 D46), October 22 - 24 BioEurope in Vienna, Austria (booth 44), November 4 - 6 or visit us at www.richter-helm-biotec.eu or contact Richter-Helm BioTec GmbH & Co. KG Dr. Kai Pohlmeyer - Head of Business Development Tel: +49-40-55 290 430 e-mail: k.pohlmeyer@richter-helm-biotec.eu
Richter-Helm ist ein wachstumsstarkes deutsches Biotechnologie-Unternehmen mit Hauptsitz in Hamburg, das spezialisiert ist auf die Entwi... [mehr]