Over the past 30 years Richter-Helm gained substantial experience in the development and manufacture of different product classes (e.g. recombinant proteins, antibodies, plasmid DNA, and vaccines). The company currently operates a development facility and two cGMP manufacturing facilities with bioreactor capacities of up to 1,500 liters, enabling GMP manufacturing for phase I to III up to commercial supply. With flexibility, commitment to good manufacturing practice, and total transparency, our seasoned, 250-strong team offers highly specialized contract development and manufacturing services to support the global pharmaceutical and biotechnological industries.
To meet the high quality requirements, Richter-Helm consistently works to the highest standards of pharmaceutical quality. This has been verified by major regulatory bodies, including the EMA, FDA, ANVISA, PMDA, and MFDS, as well as by numerous customer audits.
Products and services:
The highly motivated and experienced teams at Richter-Helm have excellent expertise in development and GMP-compliant production of biopharmaceuticals. To ensure efficient and transparent work, we apply professional project management methods.
Our process development team possesses extensive experience in developing and optimising fermentation and purification processes. For initial strain development, a variety of proprietary E. coli expression systems is available to
support strain selection. Small scale models of existing processes provide helpful tools for trouble shooting, process characterisation, and validation. Furthermore, small scale models also ensure a smooth scale-up to large-scale GMP-compliant manufacture. The quality system at Richter-Helm meets the strictest standards of quality in biopharmaceutical production.
Our in-house QC testing covers development and validation of a variety of analytical methods (incl. biological assays), performance of stability studies, and characterization of reference standards.
Richter-Helm offers a full range of biopharmaceutical manufacturing services, including:
- Establishment of cell banks (MCB/WCB)
- GMP manufacturing for phase I to III
- Commercial GMP manufacturing
Thanks to the broad knowledge of Richter-Helm´s experts and many years of experience gained from different kinds of projects, Richter-Helm works out tailor-made solutions for its worldwide customers, which include large pharmaceutical companies as well as advanced biotech companies. We treat each of our customers’ projects individually and with the highest flexibility – guaranteeing a successful partnership.
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