Abionyx Pharma, a new generation biotech company dedicated to the discovery and development of therapies based on the world’s only natural recombinant ApoA-I, reported the successful GMP industrial biomanufacturing of a batch of CER-001 using an innovative and robust method.

In a statement, the company said that the success confirms the relevance of the strategy to relocate biomanufacturing to France, which was implemented four years ago, not only to contribute to the country’s industrial sovereignty in biomedicine, but also to ensure the independence of the company’s development from external constraints.

The performance also testifies to the efforts and hard work of Abionyx’s teams who worked to optimize the industrial process, despite raw material inflation, a difficult context, and limited financial resources. Finally, this major manufacturing improvement simplifies the process by making it more competitive, which increases the value of the bioproduct and of Abionyx Pharma, which controls the manufacturing and intellectual property rights.

Abionyx successfully manufactured a GMP-compliant batch of CER-001 using a new innovative and robust industrial process. Abionyx thus demonstrates that the new production line constitutes an innovative and efficient approach to access the apotherapy market, based on the only human recombinant ApoA-I protein. All the steps of the biomanufacturing process have been revisited, improved, and requalified in order to increase the production yield and to serve the targeted markets such as renal diseases, sepsis, or ophthalmology.

According to the company, with this successful manufacturing of the first batch, the new manufacturing process was confirmed, advancing apotherapy programs into larger global therapeutic trials to explore new clinical benefits for ApoA-I replacement therapy.