ABIONYX Pharma Triples Yield on Key Component of Its Sepsis Treatment
ABIONYX Pharma announces the development of a new manufacturing process for synthetic sphingomyelin, a key component of its CER-001 product for sepsis treatment. This breakthrough aims to secure bioproduction on an industrial scale and upcoming regulatory steps.
Innovative Production Process Developed
The biopharmaceutical company has developed a new process that triples the production yield of sphingomyelin, one of the two major components of CER-001. This synthetic sphingomyelin is characterized by exceptional purity and structural quality that meets the most stringent pharmaceutical standards. The synthesis processes are based on patents fully owned by ABIONYX Pharma, creating a significant technological and competitive barrier. The use of 100% synthetic sphingomyelin instead of traditional sources (egg or bovine) eliminates any risk of contamination, variability in raw materials, and allergic risks.
Enhanced Stabilization and Therapeutic Capabilities
In the biomedicine CER-001, sphingomyelin stabilizes the apoA-I protein in an optimally functional conformation and enhances the product's biological and therapeutic capabilities. This advancement will directly benefit the manufacturing of the two validation batches required before the Market Authorization in LCAT deficiency, ensuring high purity, optimal reproducibility, and secured supply. ABIONYX Pharma positions this success as a validation of its industrial approach to the apoA-I platform and the preparation for clinical and regulatory stages. The company also highlights that mastering synthetic sphingomyelin could open other commercial opportunities, especially in advanced cosmetics, where this component is used for its abilities to stabilize and protect biological structures.
