Contract development and GMP manufacturing of biological products derived from microbial expression systems.
Richter-Helm is a leading and expanding Germany-based contract development and manufacturing company (CDMO) specialized in products derived from bacteria and yeasts.
With a proven 30-year track record our work focuses on plasmid DNA, recombinant proteins, antibody fragments, and vaccines. First-hand knowledge and an excellent proprietary, highperformance pDNA process, namely RHB-pART, that delivers pDNA used for different purposes: as the API, as raw material for virus production, or as a template for mRNA products bring our customer´s projects to success.
Our seasoned highly educated and motivated team supports you with process development, supply of products for clinical trials, commercial production, in-house QC testing, and QP release. In collaboration with Gedeon Richter, one of our mother companies, we are able to offer mammalian cell based DS production and fill and finish capacities as well.
We operate two GMP-compliant production sites with bioreactor capacities of up to 1500 liters, enabling GMP manufacturing for phase I to III up to commercial supply. A major expansion of production capacity will triple production capacity by mid of 2024. Two highly flexible production trains with interchangeable product flows will be established in a second facility at one of our existing production sites.
Richter-Helm consistently works to the highest standards of pharmaceutical quality. This has been verified by major regulatory bodies including e.g. EMA, FDA, PMDA, ANVISA, MFDS and more as well as by numerous customer audits.
In addition Richter-Helm is the platform of its mother companies Gedeon Richter and Helm AG for worldwide licensing options as well as partnerships for co-development and marketing of microbial derived biopharmaceutical projects.
Richter-Helm is a leading and expanding Germany-based contract development and manufacturing company (CDMO) specialized in products derived from bacteria and yeasts.
With a proven 30-year track record our work focuses on plasmid DNA, recombinant proteins, antibody fragments, and vaccines. First-hand knowledge and an excellent proprietary, highperformance pDNA process, namely RHB-pART, that delivers pDNA used for different purposes: as the API, as raw material for virus production, or as a template for mRNA products bring our customer´s projects to success.
Our seasoned highly educated and motivated team supports you with process development, supply of products for clinical trials, commercial production, in-house QC testing, and QP release. In collaboration with Gedeon Richter, one of our mother companies, we are able to offer mammalian cell based DS production and fill and finish capacities as well.
We operate two GMP-compliant production sites with bioreactor capacities of up to 1500 liters, enabling GMP manufacturing for phase I to III up to commercial supply. A major expansion of production capacity will triple production capacity by mid of 2024. Two highly flexible production trains with interchangeable product flows will be established in a second facility at one of our existing production sites.
Richter-Helm consistently works to the highest standards of pharmaceutical quality. This has been verified by major regulatory bodies including e.g. EMA, FDA, PMDA, ANVISA, MFDS and more as well as by numerous customer audits.
In addition Richter-Helm is the platform of its mother companies Gedeon Richter and Helm AG for worldwide licensing options as well as partnerships for co-development and marketing of microbial derived biopharmaceutical projects.
Focus Areas
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