Abionyx Pharma, a biotech company dedicated to the discovery and development of therapies based on natural recombinant ApoA-I, has successfully completed a second batch for the GMP industrial biomanufacturing of CER-001 using an innovative and robust method.

This confirms that Abionyx’s new production line 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.

The second batch confirms the improved yield and simplification of the biomanufacturing process defined and followed for industrialization. 

Before applying for marketing approval, based on the success of clinical trials, at least three consecutive batches using the intended commercial process must be manufactured in accordance with 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.

Also, to obtain regulatory approval, the company must provide data on the long-term stability of the biomedicine, which involves carrying out stability tests on three consecutive batches to determine the product’s shelf life.