Richter BioLogics stands at the forefront of Germany’s contract development and manufacturing sphere, with a specialized focus on products derived from bacteria and yeasts. Our facilities boast capacities of 2 x 1,500L and 2 x 300L, facilitating the production of antibodies, including VHH/nanobodies, proteins, plasmid DNA and vaccines. For plasmids at different sizes and qualities needed we offer a proprietary process called pART.
With over 35 years of proven success, our highly skilled teams are dedicated to supporting clients through every stage of production. We offer robust process development, supply products for clinical trials, oversee commercial production, conduct in-house quality control testing, and provide QP release. Our commitment to excellence is reflected in our adherence to the highest pharmaceutical quality standards, as verified by major regulatory bodies such as EMA, FDA, ANVISA, PMDA, and MFDS, alongside numerous customer audits.
At Richter BioLogics, we pride ourselves on delivering reliable solutions with precision and expertise, ensuring our partners achieve their clinical and commercial goals with confidence.
Products and services:
The highly motivated and experienced teams at Richter BioLogics 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 BioLogics 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 BioLogics 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 BioLogics´ experts and many years of experience gained from different kinds of projects, Richter BioLogics 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.
