Abionyx Pharma, a biopharmaceutical company headquartered in Toulouse, France, has partnered with contract development and manufacturing organization (CDMO) Axplora to purify recombinant human apolipoprotein A-I (apoA-I), the protein used in its investigational drug CER-001. Purification will take place at Axplora’s facility in Pompey, France, as Abionyx prepares for further regulatory and clinical development of the product.

CER-001 combines full-length recombinant human apoA-I, a 243-amino-acid protein, with phospholipids to form a high-density lipoprotein (HDL)-like particle. The manufacturing process includes protein production and purification, assembly with phospholipids, and final pharmaceutical manufacturing operations.

The partnership establishes roles for three manufacturing and development partners across the CER-001 production process. According to the announcement, Axplora will handle purification, while Olon is responsible for producing recombinant human apoA-I, combining it with phospholipids, and filling and finishing. Texcell is also part of the product’s manufacturing and control network. The process remains subject to required validations.

Abionyx is developing CER-001 for two indications. For lecithin-cholesterol acyltransferase (LCAT) deficiency, the company is preparing regulatory steps toward a potential market launch. For sepsis, it is preparing RACERS 2, a Phase 2b clinical trial that follows RACERS 1, which enrolled 17 patients. Abionyx secured €33 million in funding in June 2026 to support the next phase of clinical development, according to the company.

The agreement follows Axplora’s progress on a separate manufacturing program for Exatecan, a starting material used in antibody-drug conjugate (ADC) payloads. In September, Axplora reported completing its first research and development batches and said it planned validation batches by the end of 2026, with initial good manufacturing practice supply targeted for late 2027, subject to technical, quality, and regulatory milestones.