Richter-Helm, a full-service biopharmaceutical contract development and manufacturing organization, has announced that the US 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."
