ABIONYX Pharma has finalized the manufacturing network for its investigational biologic CER-001 through a strategic partnership with contract development and manufacturing organization (CDMO) AXPLORA. The agreement establishes a dedicated purification process for recombinant human apolipoprotein A-I (apoA-I), a key component of CER-001, as the company advances development for lecithin-cholesterol acyltransferase (LCAT) deficiency and sepsis.

Purification operations will take place at AXPLORA’s facility in Pompey, France, which brings more than 30 years of experience in purification technologies. The partnership completes the main elements of ABIONYX’s planned production chain, which spans recombinant protein manufacturing, purification, assembly with phospholipids and final pharmaceutical manufacturing operations.

CER-001 consists of full-length recombinant human apoA-I, a 243-amino-acid protein, combined with specific phospholipids to form a biomimetic high-density lipoprotein (HDL) particle. The candidate is designed to support the removal of endotoxins and modulate immune responses. Its manufacture requires close control of protein structure and function, as well as consistency and quality across the finished product.

AXPLORA joins TEXCELL and OLON in ABIONYX’s network of industrial partners. TEXCELL is involved in manufacturing and control activities, while OLON is responsible for recombinant apoA-I production, its combination with phospholipids, and filling and finishing. AXPLORA will contribute specialist purification capabilities intended to support a reproducible manufacturing process. The company says the network provides an industrial foundation for further regulatory and clinical development, subject to completion of the required validations.

The manufacturing milestone supports two development programs for CER-001. In LCAT deficiency, ABIONYX is preparing the next regulatory steps toward a potential first market launch. The rare inherited disorder affects the enzyme responsible for esterifying cholesterol and can cause serious kidney and other systemic complications. In parallel, the company is preparing a Phase 2b study of CER-001 in sepsis, a life-threatening condition associated with an abnormal immune-inflammatory response and organ dysfunction.

The planned sepsis trial, RACERS 2, follows the earlier RACERS 1 study, which enrolled 17 patients. ABIONYX said it secured $36 million in funding in June 2026 to support the next phase of clinical development. Although the two programs involve different patient populations and regulatory requirements, they rely on the same biologic candidate and manufacturing infrastructure.

“We are finalizing the structuring of the entire CER-001 manufacturing chain by effectively and structurally combining the complementary expertise of TEXCELL, OLON, and AXPLORA,” says Cyrille Tupin, CEO of ABIONYX Pharma. He describes the manufacturing work and preparation for the Phase 2b study as important steps as the company moves into the next stage of development.

Arul Ramadurai, chief commercial officer of AXPLORA, says the company’s purification expertise at its Pompey site would support efforts to establish a reliable manufacturing process in collaboration with ABIONYX and its other partners.

With the manufacturing network now established, ABIONYX aims to strengthen CER-001’s readiness for further development and potential regulatory approval in LCAT deficiency while progressing its clinical investigation in sepsis. Completion of the manufacturing framework represents an operational milestone, although additional development, validation and regulatory work will be required before the candidate can reach the market.

For more information, visit www.abionyx.com.