Richter Biologics Opens New Plant, Eyes Major 2025 Commercial Production Deal

After over three years of development, Richter Biologics has officially opened its new multipurpose production facility, significantly expanding its capacity for bacterial production of pDNA, vaccines, nanobodies, and recombinant proteins. The newly launched P2 unit features fully equipped production lines for 1,500-liter and 300-liter batches, alongside the pre-existing 1,500-liter line, all designed to handle interchangeable product streams. With this expansion, Richter Biologics, along with its parent company Gedeon Richter, is now positioning itself to meet the demands of commercial manufacturing.

Starting in 2025, the 1,500-liter production line will be dedicated to commercial manufacturing for a major pharmaceutical client, for whom Richter Biologics had previously produced Phase III lots during the COVID-19 pandemic. The client sought to partner with Richter for full-scale commercial production once regulatory approval was granted. Additionally, Richter Biologics is planning a new 3,000-liter production line for Phase II antibody production, fulfilling the needs of another long-standing pharmaceutical partner that is also exploring commercial production opportunities.

With the 1,500-liter and 300-liter production lines, designed to boost output from 40 to 120 batches annually, nearing full capacity from the outset, Richter Biologics has opted to delay its planned U.S. expansion under the 2024+ strategy. Instead, the company will focus on building local sales capabilities for the next two to three years, according to Managing Director Dr. Kai Pohlmeyer, as reported to European Biotechnology. Except for potential acquisitions related to strain development and other upstream processes, the company aims to "grow organically" in the U.S., where most of its client base is located, by concentrating on microbial production of pDNA, peptides, and antibody-like scaffolds such as nanobodies and Fab fragments.

Gedeon Richter has invested €95 million in the expansion, extending Richter Biologics’ production space to 10,000 square meters. By hiring 60 skilled scientists and engineers, the company has taken advantage of the recent wave of layoffs in the German biotech sector. Looking ahead, Pohlmeyer plans to maintain a steady flow of innovative biotech products, serving its existing pharmaceutical partners. He also noted that Richter Biologics is set to achieve growth in 2024 for the twelfth consecutive year.

At the inauguration event, Dr. Erik Bogsch, Honorary Chairman of Gedeon Richter, shared his thoughts on the establishment of the foundation and outlined his long-term vision for the collaboration with Richter Biologics. Earlier in March, Gedeon Richter acquired 100% of Helm AG, a company focused on chemical operations, and subsequently secured a 30% stake in Richter Biologics, which was rebranded during the event, along with a 50% ownership in Richter Biotec. Despite the changes, customers will experience no disruption, according to Pohlmeyer, who assured European Biotechnology that only the company name and email addresses will be updated. Previously, under its former identity, Richter-Helm Biologics had entered into a strategic partnership in December 2022 with Nykode Therapeutics ASA, a Norwegian vaccine specialist, to supply pDNA.