Axplora Opens cGMP Pilot Plant for Flow Chemistry in Leverkusen

25.07.2023 - Axplora has completed the installation of a new cGMP (cyclic guanosine monophosphate) pilot unit at its German site in Leverkusen, costing more than €1 million.

With the commissioning of the flow chemistry plant, the partner of pharmaceutical and biotech companies for the production of complex active pharmaceutical ingredients (APIs) continues its investment in special technologies as a differentiating factor.

Technologies such as flow chemistry enable more efficient, sustainable production operations. In 2013, Axplora (then called Novasep, see below) set up a specific research platform at its French site in Chasse-sur-Rhône to develop methods for efficient process development under continuous flow conditions using chemical and engineering expertise. Thanks to the new, highly flexible facility, Axplora can operate over a wide range of temperatures and pressures (-50°C to 200°C and up to 40 bar), adapting reactor configurations to the specific requirements of each process to optimize control and productivity of challenging reactions.

"Continuous flow technology can improve the robustness, sustainability and safety of many chemical processes. It is an enabling technology that allows the safe generation and use of hazardous intermediates, as well as operation under high temperatures and pressures," explains David Cantillo, flow chemistry expert and area leader at the Research Center Pharmaceutical Engineering GmbH (RCPE) at the University of Graz, Austria. "Furthermore, the enhanced heat and mass transfer characteristic of flow reactors improve the outcome of fast and exothermic transformations."

Ester Masllorens, Chief Technology Officer of Axplora. explains. "Continuous processing is a key enabling technology for the future of pharmaceutical manufacturing, strongly supported by regulatory bodies such as the FDA. This technology has high potential to enhance sustainability, improve control and quality as well as reduce costs and time to market. My warm thanks to our team involved in making it possible."

"Hazardous chemistry is our core competence at Leverkusen," adds Oliver Plietzsch, Head of Research & Development at Axplora's Leverkusen site. "We are excited to implement flow chemistry at pilot scale as it enhances our possibilities to develop safe, sustainable and efficient processes for our customers."

Earlier in April 2022, pharmaceutical contract development and manufacturing organisations (CDMOs) PharmaZell and Novasep had announced the completion of their merger. The company formed by the merger has been operating under the name Axplora since last autumn and specialises in the development and scaling of complex production processes for active pharmaceutical ingredients.

Read our CHEManager-Interview with Sylke Hassel, CEO, Axplora.



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