Abionyx Pharma Entrusts Olon with Manufacturing of CER-001 for Market Launch

Two French Olon Sites Mobilized at Key Production Stages

Abionyx Pharma, a biopharmaceutical company based in Balma, has announced a manufacturing partnership with Olon, a pharmaceutical contract development and manufacturing organization (CDMO). Activities will be conducted at two sites located in France.

The partnership covers two stages of the process: the production by cell culture of recombinant human apoA-I, then, after purification, the complexation of this protein with phospholipids to form CER-001, followed by filling and finishing.

CER-001 is based on a complete recombinant human apoA-I of 243 amino acids, assembled with specific phospholipids to form a biomimetic HDL particle. According to the company, manufacturing requires reproducible assembly into a homogeneous and stable biological particle.

Validation Batches First, Commercial Capacity Conditional Later

The immediate objective of the collaboration is the manufacturing of two validation batches. The longer-term objective is to have, should CER-001 obtain regulatory authorization, the infrastructure and capacities necessary to supply the market.

"CER-001 is a biopharmaceutical product that is demanding to manufacture," declared Cyrille Tupin, chief executive officer of Abionyx Pharma, noting that building a reliable process transferable to larger scale required years of development. For Andrea Conforto, vice president in charge of Olon's biotechnology CDMO business, these batches represent "an important first step," with the manufacturing strategy having been designed from the outset based on CER-001's long-term requirements.

Olon, headquartered in Rodano, near Milan, operates 14 production sites and 14 R&D centers worldwide, with more than 2,800 employees.

The Same Platform for LCAT Deficiency and Sepsis

In LCAT deficiency, an ultra-rare genetic disease, Abionyx Pharma is pursuing a regulatory pathway presented as a potential first market entry point for CER-001. The two validation batches are part of the preparation of the associated manufacturing dossier.

In parallel, the company is advancing CER-001 in phase 2b in sepsis, a significantly larger patient population. The two programs differ in their scope and development pathway, but share the same product and the same manufacturing platform.