ABIONYX Pharma (Euronext Paris:ABNX), a biopharma company focused on breakthrough biotherapies to address life-threatening conditions with no effective treatments, announced on Wednesday that it has entered into a strategic manufacturing partnership with OLON, a global CDMO, to support the regulatory development and potential commercialisation of CER-001, its full-length recombinant human apoA-I biologic for sepsis and critical care.

The collaboration initially covers two validation batches of CER-001, supporting ABIONYX's regulatory strategy for LCAT deficiency while establishing capabilities for potential commercial production. Manufacturing will take place across two OLON sites in France, covering recombinant human apoA-I cell-culture production, purification, complexation with phospholipids and fill-and-finish.

CER-001 uses full-length recombinant human apoA-I, a 243-amino-acid protein assembled with specific phospholipids to form a biomimetic HDL particle. ABIONYX said its accumulated manufacturing expertise, intellectual property and know-how represent an important part of the product's differentiation and create a technological barrier to replication.

The partnership is intended to establish a robust, reproducible and scalable manufacturing framework that can support CER-001 from regulatory validation through potential market entry and subsequent commercial scale-up.

The manufacturing programme supports two development paths for CER-001: an intended regulatory pathway in LCAT deficiency, an ultra-rare genetic disease, and Phase 2b development in sepsis. The company aims to use the same manufacturing platform to support potential initial market entry in LCAT deficiency while developing the biologic for the larger sepsis opportunity.