ABIONYX Pharma announced the successful completion of a second batch for the GMP (Good Manufacturing Practice) industrial biomanufacturing of CER-001 using an innovative and robust method. ABIONYX has successfully manufactured a second batch of CER-001 under GMP conditions, using a novel and robust industrial process. This confirms that ABIONYX's new production line, based on an innovative and efficient approach, is ready to enter the Apotherapy market, based on the only natural recombinant ApoA-I protein.

All stages of the biomanufacturing process are designed to increase production yields, enabling ABIONYX Pharma to serve its target markets in kidney disease, sepsis and ophthalmology. This second batch confirms the improved yield and simplification of the biomanufacturing process defined and followed for industrialization. This batch confirms that all industrial barriers have been crossed to ensure the generation of production volumes consistent with future needs.

Before applying for marketing approval, based on the success of clinical trials conducted to assess the efficacy and safety of the biomedicine, at least 3 consecutive batches using the intended commercial process must be manufactured in accordance with Good Manufacturing Practices (GMP) in order to obtain regulatory approval. Biomedicines manufactured in compliance with GMP guarantee the quality, safety and reliability of the bioproduct in order to meet regulatory requirements. Finally, to obtain regulatory approval, the biotech must also provide data on the long-term stability of the biomedicine.

This involves carrying out stability tests on 3 consecutive batches to determine the product's shelf life. In fact, due to the successful production of this second batch, the new manufacturing process has been reconfirmed, positioning on a biomanufacturing trajectory that will require the completion of 3 consecutive GMP pilot batches at the yield level of CER-001's future commercial operation.