Abionyx Pharma Partners with Axplora and Completes CER-001 Production Chain
On October 27, 2026, Abionyx Pharma announced a manufacturing partnership with pharmaceutical contract manufacturer Axplora. This agreement adds to those already concluded with Texcell and Olon: according to the company, it completes the structuring of its biomedical drug CER-001 production chain.
Axplora Tasked with Purification of Recombinant apoA-I
Axplora is a contract development and manufacturing organization (CDMO). It will leverage its purification expertise for recombinant human apoA-I, the key biological component of CER-001. The partnership is also intended to support the next development stages of the program.
Operations will be conducted at Axplora's site in Pompey, France. According to the press release, this site brings together more than 30 years of purification expertise. Axplora resulted from the merger of PharmaZell, Farmabios and Novasep CDMO and operates nine active pharmaceutical ingredient production sites in Europe and India.
Three Partners Distributed Across Manufacturing Steps
CER-001 is based on complete recombinant human apoA-I, a protein of 243 amino acids. It is combined with phospholipids to form a biomimetic HDL particle. Its manufacturing involves several stages: protein production, purification, assembly with phospholipids, then final pharmaceutical operations.
Roles are divided among three partners. Olon notably ensures the production of recombinant apoA-I, its complexation with phospholipids as well as filling and finishing. Texcell is integrated into the manufacturing and quality control system. On October 7, 2026, Abionyx Pharma announced its agreement with Olon, which initially provided for the production of two validation batches of CER-001 intended for its regulatory strategy in LCAT deficiency.
The company presents this network as an industrial foundation for the next regulatory and clinical stages. However, this foundation remains conditional on obtaining the required validations.
The Same Industrial Chain for Two Programs
The same production is to serve two programs. In LCAT deficiency, Abionyx Pharma is preparing the next regulatory stages with a view to potential initial market launch. In sepsis, the company is preparing a phase 2b clinical trial, RACERS 2.
This trial was made possible by securing 33 million euros in funding in June 2026. It follows, on a larger scale, RACERS 1, which involved 17 patients. The two programs differ in their patient populations, their clinical requirements and their regulatory pathways.
For Cyrille Tupin, Chief Executive Officer of Abionyx Pharma, the company is entering "an execution phase" where each industrial, regulatory and clinical step must reduce risks associated with the development of CER-001.
