Axplora has entered into a strategic manufacturing partnership with Abionyx Pharma to support the development of CER-001, an investigational biopharmaceutical being developed for LCAT deficiency and sepsis.
Under the partnership, Axplora’s Pompey site in France will apply its specialist purification expertise to recombinant human apoA-I, the key biological component of CER-001. The collaboration brings together Pompey’s technical capabilities and Abionyx’s therapeutic development expertise to help establish a reliable, reproducible manufacturing process.
Axplora joins Abionyx’s existing partners, Texcell and Olon, completing a network that covers the main stages of CER-001 production. Together, these complementary capabilities provide a manufacturing foundation for the program’s next stages, subject to completion of the required validations.
Cyrille Tupin, CEO of Abionyx Pharma, stated:
“We are finalizing the structuring of the entire CER-001 manufacturing chain by effectively and structurally combining the complementary expertise of Texcell, Olon, and Axplora. Following the securing of our financial resources, the structuring of our production chain and the preparation of our Phase 2b clinical program represent transformative steps in this journey. We are entering an execution phase in which every industrial, regulatory, and clinical milestone reduces the risks associated with the development of CER-001 day by day and secures its long-term value creation potential.”
Specialist purification for a complex biopharmaceutical
CER-001 combines a full-length recombinant human apoA-I protein with specific phospholipids to form a particle that mimics high-density lipoprotein, or HDL.
Manufacturing this complex biopharmaceutical requires a series of carefully controlled steps: producing and purifying the protein, assembling it with phospholipids, and completing the final pharmaceutical manufacturing operations. Throughout this process, preserving the protein’s structural and functional characteristics is essential to the quality, consistency and reproducibility of the final product.
Pompey brings more than 30 years of purification expertise to this challenge. Its team will work alongside Abionyx and its other manufacturing partners to support a process that meets the program’s development needs.
Supporting the next stages of development
Abionyx is pursuing two development pathways for CER-001. The company is preparing the next regulatory steps toward a potential first approval in LCAT deficiency, while also preparing a Phase 2b clinical trial in sepsis.
Although these programs have different patient populations, clinical requirements and regulatory pathways, they use the same biologic product. A coordinated manufacturing network will support both pathways as CER-001 progresses through development.
Partnership in Motion at Pompey
For Axplora, the collaboration demonstrates how understanding a customer’s development challenges and applying specialist expertise can help a potential new medicine move forward.
Arul Ramadurai, Chief Commercial Officer of Axplora, commented:
“Strong partnerships start with understanding what a customer needs to achieve and the challenges we need to solve together. Our team at Pompey, in France, brings more than 30 years of purification expertise to help Abionyx build a reliable manufacturing process for CER-001. Working alongside Abionyx and its other specialist partners, we are focused on turning that expertise into progress toward a shared goal: bringing a potential new treatment to patients who need better options. This is what Partnership in Motion means to us.”
