Axplora Announces €50 Million Investment in GLP-1 Manufacturing in France

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Axplora, a Germany-based API small-molecule and antibody-drug conjugate (ADC) manufacturer, announced on Feb. 12, 2025 a €50 million (US$52 million) investment is being made in its site in Mourenx, France, with the intention of making the site a center of excellence within the company’s network for contract manufacturing of APIs and drug substances for biologics that have been FDA approved (1).

Previously, in August 2022, a €7.3 million (now US$7.6 million) investment had been made in the Mourenx site to create a pilot workshop supporting a growing demand for APIs, particularly highly potent APIs to treat cancer. That investment was announced by what was then the Novasep-PharmaZell Group; Novasep and PharmaZell, which had just merged in April 2022, were then unified along with Farmabios under the brand name Axplora in October 2022 (2).

The new tranche of money, Axplora said, will be used to upgrade the Mourenx site’s infrastructure and capabilities related to peptide purification in a biologics environment. The company is also looking toward the development of next-generation therapeutics, specifically glucagon-like peptide-1 (GLP-1) drugs targeting obesity and diabetes (1).

“GLP-1 therapies represent a paradigm shift in medicine, offering targeted therapies for complex diseases with unprecedented efficacy and tolerability,” Arul Ramadurai, Axplora chief commercial officer, said in the release. “This initiative, built on strong customer partnerships, reinforces Axplora’s role as a trusted partner in manufacturing life-changing, breakthrough medicines.”

In December 2024, FDA approved Hikma Pharmaceuticals USA’s liraglutide injection, the first generic referencing Victoza (liraglutide injection) 18 mg/3 mL from Novo Nordisk (3). The generic was indicated for improving glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise. FDA noted at the time that there is a drug shortage of liraglutide injection and certain other GLP-1 medications, and the agency is thus prioritizing assessment of generic-drug applications for drugs in shortage to help improve patient access to these medications, aligning with the mission Axplora has set forth with this investment.

“This project is testament to our pioneering expertise in industrial chromatography, and working closely with our client, we target having the facility BLA [biologics license application]-ready in 15 months,” Pere Patón-Morales, PhD, Axplora chief operating officer, said in the release. “To achieve this our internal teams are working closely with partners in a strong cross-functional project team, well-supported by the local authorities. We are looking forward to a bright future at Mourenx.”

Axplora said its vision is for the Mourenx site to remain a “key contributor to Axplora’s API network” into the 2030s, and that construction and infrastructure development enabled by this most recent investment would begin immediately, with a goal of having the site’s first supplies of GLP-1 therapies available in 2026 (1). Mourenx is one of nine Axplora API manufacturing sites currently operating across Europe and India, helping the company partner with more than 900 pharmaceutical and biotech companies worldwide, according to the press release.

References

1. Axplora. Axplora Announces €50 Million Investment in GLP-1 Manufacturing at Mourenx (France) Site. Press Release. Feb. 12, 2025.
2. Axplora. Farmabios, Novasep and PharmaZell are Now Axplora. Press Release. Oct. 19, 2022.
3. FDA. FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes. Press Release. Dec. 23, 2024.