Advertisement Richter-Helm Obtains FDA Approval for Commercial Production of a Therapeutic Recombinant Protein - Pharmaceutical Business review

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Richter-Helm Obtains FDA Approval 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."

Richter-Helm office

To find out more please contact Richter-Helm. Feel free to visit us at the following events:

  • BioTalk Manufacturing Excellence Berlin, Germany, 26 – 27 September
  • CPhI / ICSE in Frankfurt, Germany (booth 3.1 D46), 22 – 24 October
  • BioEurope in Vienna, Austria (booth 44), 4 – 6 November