ABIONYX Taps OLON for CER-001 Validation Batches at Two France Sites

ABIONYX Pharma has enlisted contract development and manufacturing organization OLON to produce two validation batches of CER-001, a step the company describes as a key milestone in its regulatory strategy for LCAT deficiency, while simultaneously laying the industrial groundwork for eventual commercial supply.

The partnership, announced from Toulouse, France, and Fullerton, California, on October 7, 2026, covers manufacturing activities across two OLON sites in France.

It is intended to do more than deliver the validation batches: the two companies are establishing a manufacturing framework designed to carry CER-001 through potential market entry and subsequent commercial scale-up.

From clinical production to commercial readiness

The immediate objective of the collaboration is the successful manufacture of the two validation batches. The longer-term objective is to ensure that, should CER-001 receive regulatory approval, the manufacturing infrastructure needed to supply the market is already in place.

With this partnership, ABIONYX is moving beyond manufacturing CER-001 solely for clinical development and beginning to establish the infrastructure required for potential commercialization.

The two validation batches provide the immediate milestone, while the stated strategic objective is a scalable manufacturing platform capable of supporting CER-001 from a potential first market entry in LCAT deficiency to a substantially broader opportunity in sepsis.

A demanding biologic built on full-length apoA-I

CER-001 presents what the companies describe as a distinctive manufacturing challenge. Unlike approaches based on short apoA-I-derived peptides, CER-001 incorporates full-length recombinant human apoA-I, a 243-amino-acid protein, which is subsequently assembled with specific phospholipids to form a biomimetic HDL particle.

Producing the protein is only part of the process. Manufacturing CER-001 also requires the reproducible assembly of apoA-I and phospholipids into a homogeneous and stable biological particle with the required pharmaceutical characteristics. This complexity is closely tied to the product's design.

By retaining full-length apoA-I within an HDL-like particle, CER-001 is designed to reproduce key structural and functional properties of naturally occurring nascent HDL and to enable biological activity throughout the circulation.

ABIONYX has accumulated considerable manufacturing experience around CER-001 over the course of its development. According to the company, the process, together with its intellectual property and accumulated manufacturing know-how, represents an important part of the asset's differentiation and creates a meaningful technological barrier to replication.

The OLON partnership is intended to translate that experience into a robust, reproducible, and scalable manufacturing process suitable for potential commercial supply.

How the manufacturing process is divided

ABIONYX will be involved at two critical stages of the manufacturing process carried out at OLON's French sites: the upstream cell-culture production of recombinant human apoA-I and, following purification, the complexation of apoA-I with phospholipids to form CER-001, followed by Fill and Finish.

The partnership therefore extends beyond the production of the validation batches themselves, establishing an integrated framework intended to carry the biologic from regulatory validation through potential commercial supply.

What the executives said

Cyrille Tupin, Chief Executive Officer of ABIONYX Pharma, commented on the complexity of the biologic and the significance of the partnership.

"CER-001 is a demanding biologic to manufacture," Tupin said.

"We produce the full-length, 243-amino-acid human apoA-I protein and then assemble it with specific phospholipids into a biomimetic HDL particle. Building a reliable and scalable process around that complexity has taken years of development and know-how. 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."

Andrea Conforto, M&S VP CDMO Biotech at OLON, emphasized the breadth of expertise the collaboration draws upon.

"Our work with ABIONYX brings together several areas of OLON's biomanufacturing expertise, from the upstream production of a full-length recombinant protein to the complexation of apoA-I with phospholipids and Fill and Finish," Conforto said.

"The validation batches represent an important first milestone, but the manufacturing strategy has been designed from the outset with the longer-term requirements of CER-001 in mind. The program reflects our ability to manage complex biologics manufacturing processes and to support innovative products as they progress from clinical development towards potential commercial supply."

A single platform for two development paths

According to the announcement, the manufacturing investment also supports ABIONYX's broader strategy, with a single manufacturing platform intended to serve two development paths.

The first is the company's regulatory strategy in LCAT deficiency, where the two validation batches constitute a key milestone.

The second is the ongoing Phase 2b development of CER-001 in sepsis, for which the partnership includes provisions for commercial production.

ABIONYX Pharma is listed under ticker ABNX.PA, with ISIN FR0012616852, and its shares are eligible for the PEA PME. The company describes itself as developing innovative therapies for sepsis and critical care based on a proprietary apoA-I technology platform. The announcement arrives as ABIONYX prepares CER-001 for the transition from development to market.

With manufacturing activities spanning upstream cell-culture production, complexation, and Fill and Finish across OLON's French sites, the company is positioning itself to move CER-001 from clinical-stage manufacturing toward the industrial capabilities that would be needed if the biologic secures regulatory approval, first in LCAT deficiency and, in parallel, in the larger sepsis indication currently in Phase 2b development.