Richter-Helm Biologics triples production capacity

With the inauguration of the new production unit P2, which contains fully equipped production lines for 1500 l and 300 l batches with interchangeable product streams in addition to the existing 1,500 l production line, the CDMO Richter Biologics and its Hungarian parent company Gedeon Richter are targeting the market for commercial production.

From 2025, the 1,500-litre production line will be used for commercial production for a big pharma company for which the CDMO had previously produced Phase III lots microbially and which, in the midst of the coronavirus crisis, had asked whether former Richter-Helm Biologics could also produce commercially with sufficient backup capacity following market approval. The company is currently planning a further 3,000 litre production line in the new building for a phase II antibody product for an existing pharmaceutical customer, who had also asked whether the company could take over commercial production.

As the capacity of the new 1,500 l and 300 l lines, which are intended to increase output from 40 to 120 batches per year, is already almost fully utilised at the start, Richter Biologics has postponed the expansion in the USA decided as part of the 2024+ strategy by building up local sales capacities for the time being for ‘2-3 years’, Richter Biologics Managing Director Dr Kai Pohlmeyer told European Biotechnology. With the exception of acquisitions in areas upstream of production, such as strain development, the company intends to continue to ‘grow organically’ in the USA, where most of its customers are based, focussing on the microbial production of pDNA, peptides, antibody-like scaffolds (VHH/nanobodies, Fab fragments) and plasmid, said Pohlmeyer.

Gedeon Richter invested €95m in the expansion of Richter Biologics to 10,000 square metres of production space. In recruiting 60 qualified and experienced scientists and engineers, the company says it has benefited from the current wave of redundancies in German biotech companies.

In future, Pohlmeyer intends to continue to fill the pipeline with innovative biotech products and produce them for existing pharmaceutical customers. According to the CEO, Richter Biologics will continue to grow in 2024 for the 12th year in a row.

Dr Erik Bogsch, Honorary Chairman at the Hungarian parent company Gedeon Richter, reported on the foundation and his long-term vision for the collaboration with Richter Biologics at the inauguration. In March, Gedeon Richter took over all shares of Helm AG, which focusses its business on chemistry, and now holds a 30% share in Richter Biologics, which was renamed at the inauguration, as well as 50% of Richter Biotec. ‘Apart from the name and the e-mail addresses, nothing will change for our customers,’ Pohlmeyer told European Biotechnology.

Still under the old company name, Richter-Helm Biologics had entered into a strategic product partnership with the Norwegian vaccine specialist Nykode Therapeutics ASA in December 2022 under which Richter-Helm Biologics supplies pDNA.