ABIONYX and OLON Form Strategic Partnership for CER-001 Production

ABIONYX Pharma has announced a strategic manufacturing partnership with OLON to advance the development and commercialization of CER-001, a treatment for sepsis and LCAT deficiency. CER-001 presents a complex manufacturing challenge, requiring the production of a full-length recombinant human apoA-I, a 243-amino-acid protein, assembled with phospholipids.

The partnership aims to produce two validation batches, a critical step in ABIONYX's strategy for regulatory approval. Manufacturing will occur at OLON's sites in France. The collaboration establishes a manufacturing framework from validation to potential market supply, supporting CER-001 in both niche and broader clinical contexts.

ABIONYX's goal is to leverage this manufacturing capacity for CER-001's future scale-up. This partnership is a key milestone in supporting CER-001's regulatory pathway for LCAT deficiency and its Phase 2b trial in sepsis.