Utvikling av M-SAN HQ GMP

Offentlig prosjektsammendrag

Viral vectors ar increasingly used as Advanced Therapy Medicinal Products (ATMPs) for use in gene therapy, oncology and for vaccines. ArcticZymes was the first company to launch salt-active nucleases for use in viral vector development and manufacturing, and helped pioneering the improvement of the manufacturing processes of such vectors. DNA from the eukaryotic host cell in the form of chromatin is notoriously difficult to degrade by nucleases unless using high salt to dissolve chromatin to make the DNA accessible for degradation. Enabling use of enzyme as ancillary materials into biomanufactoring of ATMPs requires compliance to applicable cGMP requirements and relevant ICH Guidelines, in particular when entering into clinical stages. The project aim to develop a GMP grade quality of ArcticZymes M-SAN product. This will be an major improvement and one of the first GMP grade salt active nucleases for use particularly within clinical stage lentivirus manufacturing.