Richter-Helm obtained FDA Approval
Richter-Helm facilities in Bovenau and Hamburg are approved for commercial production and release of a therapeutic recombinant protein.
Hamburg - September 12, 2013
The U.S. Food and Drug Administration has approved two Richter-Helm facilities, Bovenau and Hamburg, for commercial production and release of a therapeutic recombinant protein.
Richter-Helm, a joint venture of GEDEON RICHTER Plc. and HELM AG, is a full-service contract development and manufacturing organization for biotechnologically derived Drug Substances.
Richter-Helm has signed an agreement with a leading international pharmaceutical company for long-term worldwide 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), process validation and manufacturing in commercial scale.
Richter-Helm declared: "This FDA approval is an important milestone for our company and shows the level of trust and closeness in the relationship between our customer and ourselves, which is the result of many years' excellent cooperation on this ambitious development project. Our thanks go to the Richter-Helm teams, who, by virtue of strong commitment to the project and dedication to high standards, enabled to achieve this goal.”