- ABIONYX Pharma has partnered with AXPLORA to purify recombinant human apoA-I, the key biological component of CER-001, at AXPLORA’s facility in Pompey, France.
- The agreement completes the planned structure of CER-001’s manufacturing chain, supporting the program’s further development for LCAT deficiency and sepsis.
ABIONYX Pharma has entered into a strategic manufacturing partnership with AXPLORA to support production of CER-001, its investigational biopharmaceutical based on recombinant human apolipoprotein A-I (apoA-I). AXPLORA will provide specialized purification expertise at its Pompey facility in France as ABIONYX prepares for further regulatory and clinical development of the product.
The agreement completes the planned structure of CER-001’s manufacturing chain, alongside existing partnerships with TEXCELL and OLON. AXPLORA will focus on purifying recombinant human apoA-I, while OLON is responsible for protein production, phospholipid complexation, and filling and finishing operations. TEXCELL is also integrated into CER-001’s manufacturing and control system. The production network is intended to support a reproducible manufacturing process, subject to the completion of required validations.
CER-001 contains full-length recombinant human apoA-I, a 243-amino-acid protein, assembled with specific phospholipids to form a biomimetic high-density lipoprotein (HDL) particle. The product is designed to enhance the body’s immune response by eliminating endotoxins. Manufacturing requires the protein’s structural and functional characteristics to be preserved throughout purification and assembly.
ABIONYX is developing CER-001 for two indications: LCAT deficiency, for which it is preparing regulatory steps toward a potential first market launch, and sepsis, for which a Phase 2b clinical trial is in preparation. The planned RACERS 2 trial follows RACERS 1, which involved 17 patients. The company said RACERS 2 was made possible by €33 million in funding secured in June 2026.
“Strong partnerships start with understanding what a customer needs to achieve and the challenges we need to solve together. The company’s Pompey team would apply more than 30 years of purification expertise to help ABIONYX establish a reliable manufacturing process for CER-001.”
Arul Ramadurai, chief commercial officer of AXPLORA
