Primary source Olon: ABIONYX Pharma and OLON Strategic Manufacturing Partnership
Abionyx Pharma, a biopharmaceutical company based in Toulouse, France, and Fullerton, California, has signed a strategic manufacturing partnership with Olon, an Italian contract development and manufacturing organisation, to produce two validation batches of CER-001. CER-001 is Abionyx’s biomimetic HDL (high-density lipoprotein) particle, built from a full-length recombinant form of the human protein apoA-I (apolipoprotein A-I).
Two Olon sites in France
Manufacturing activities under the partnership run across two Olon sites in France. The release names two stages of the process covered: the upstream cell-culture production of recombinant human apoA-I, and, after purification, the complexation of that protein with phospholipids to form CER-001, followed by fill and finish. The release does not say which step runs at which site, or who carries out purification.
A protein, then a particle
CER-001 incorporates full-length recombinant human apoA-I, a 243-amino-acid protein, rather than the shorter apoA-I-derived peptides used in some other approaches. Once purified, the protein is assembled with specific phospholipids into what the release describes as a biomimetic HDL particle. Olon’s work covers both halves of that chain: producing the protein itself, and then the complexation step, which the release says requires the reproducible assembly of apoA-I and phospholipids into a homogeneous and stable particle with the required pharmaceutical characteristics.
Validation batches now, commercial capacity later
The immediate deliverable is two validation batches of CER-001, described as a key manufacturing milestone in Abionyx’s regulatory strategy. Beyond that, the release says the partnership is meant to put in place the manufacturing framework needed for commercial-scale supply, subject to regulatory approval. Cyrille Tupin, chief executive of Abionyx Pharma, said the company produces the full-length, 243-amino-acid human apoA-I protein and then assembles it with specific phospholipids into a biomimetic HDL particle, and that building a reliable, scalable process around that complexity has taken years of development. Andrea Conforto, M&S VP CDMO Biotech at Olon, said the program brings together several areas of Olon’s biomanufacturing expertise: the upstream production of a full-length recombinant protein, the complexation of apoA-I with phospholipids, and fill and finish.
One platform, two development paths
Abionyx is pursuing CER-001 in LCAT deficiency, which it describes as an ultra-rare genetic disease, as a potential first regulatory pathway, while separately advancing the same biologic into Phase 2b development in sepsis. The release says both programs share the same underlying product and the same manufacturing platform, so the industrial capabilities being established for the LCAT deficiency pathway are meant to support the longer-term development of CER-001, including in sepsis.
What it means for a plant
The deal shows what a CDMO has to offer a complex biologic that is not a standard monoclonal antibody: upstream cell culture for the protein, a distinct complexation step to build the lipoprotein particle, and fill and finish, all within one CDMO partnership. Olon, headquartered in Rodano, near Milan, operates 14 manufacturing sites and 14 R&D centers worldwide with over 2,800 employees; the release places this program at two of its sites in France. For a plant tracking CER-001 or a similar apoA-I complex, the two validation batches are the near-term proof point; the release does not disclose batch scale, site names or a timeline for them.
