Relevant good manufacturing practices are applied to all manufacturing activities at Richter-Helm BioLogics.
We have received production licenses for our facilities from the local German authorities. All of our production sites have also been certified as complying with the requirements of EMA, FDA, and many other international bodies.
Over the last decade, our quality systems have successfully passed more than 105 customer audits without a single negative observation or change in a customer’s choice of CMO.
Our staff’s quality mindset is strong and reflected in the significantly above-average maintenance status of our facilities. All of our facilities and equipment are of course also fully qualified for their intended uses.
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The product types manufactured with microbial expression systems at Richter-Helm BioLogics include recombinant proteins and peptides, antibody-like scaffolds (VHH/Nanobodies, Fab-fragments), plasmid DNA, and bacterial vaccines.