- ABIONYX Pharma and OLON have entered a strategic manufacturing partnership to support the development and potential commercialization of CER-001, with two validation batches planned as part of ABIONYX’s regulatory strategy for LCAT deficiency.
- Manufacturing will take place across two OLON sites in France and will cover recombinant human apoA-I production, complexation with phospholipids to form CER-001, and fill-and-finish activities.
ABIONYX Pharma and OLON have entered a strategic manufacturing partnership to prepare CER-001 for regulatory approval and potential commercial supply. The collaboration will initially focus on producing two validation batches of CER-001, supporting ABIONYX’s regulatory strategy for LCAT deficiency and establishing capabilities for potential future commercial production.
Manufacturing activities will be conducted across two OLON sites in France. The work will cover upstream cell-culture production of full-length recombinant human apoA-I, followed by purification and complexation of apoA-I with phospholipids to form CER-001, as well as fill-and-finish activities. OLON will provide CDMO capabilities across these stages.
CER-001 contains full-length recombinant human apoA-I, a 243-amino-acid protein, which is assembled with specific phospholipids to form a biomimetic HDL particle. ABIONYX said the manufacturing process requires reproducible assembly of the protein and phospholipids into a homogeneous and stable biological particle with the required pharmaceutical characteristics.
The partnership is intended to extend beyond the initial validation batches by establishing a manufacturing framework for potential market entry and subsequent commercial scale-up. The capabilities being developed for LCAT deficiency are also intended to support ABIONYX’s Phase 2b development of CER-001 in sepsis, providing a common manufacturing platform across the two development programs.
“CER-001 is a demanding biologic to manufacture. We produce the full-length, 243-amino-acid human apoA-I protein and then assemble it with specific phospholipids into a biomimetic HDL particle. Thanks to OLON, we are now putting that manufacturing capability in place for the next stage of CER-001: first through our regulatory strategy in LCAT deficiency and, in parallel, through Phase 2b development in sepsis.”
Cyrille Tupin, Chief Executive Officer of ABIONYX Pharma
