Tromsø, Norway, June 29th 2023 – ArcticZymes Technologies ASA (OSE:AZT) announces the filing of a Drug Master File (DMF) to the US Food and Drug Administration (FDA) for Salt Active Nuclease High Quality GMP Grade (SAN HQ GMP).
ArcticZymes is pleased to announce the filing of a DMF (Type II) for SAN HQ GMP with the US FDA’s Center for Biologics Evaluation and Research (CBER). The filing is intended to support SAN HQ GMP customers with regulatory filings and applications for therapeutic biological products, such as viral vaccines, viral vectors for cell and gene therapy applications, therapeutics, monoclonal antibodies, and similar.
SAN HQ GMP is a nuclease enzyme used in bioprocessing workflows to remove DNA and RNA in the manufacturing of biopharmaceuticals. The DMF contains detailed information about the manufacturing, control, packaging, and storing of the SAN HQ GMP product.
This extensive file demonstrates to the regulatory authority that the safety, quality and efficacy of the SAN HQ GMP, as an ancillary material, is of a suitable standard for use in bioprocessing workflows. The filing is provided in eCTD format and can be used to support and accelerate regulatory filings such as Biologic License Applications (BLA), Investigational New Drugs (IND), New Drug Applications (NDA), and other DMFs.
“The filing of our first DMF is a major achievement for ArcticZymes; we have invested significant financial and human resources in this important project and we are proud to have delivered on our promise to investors, to file by the end of the 1H of 2023,” said Dr Marie Roskrow, Chairman of the Board.
For more information, please contact:
| ArcticZymes Technologies | |
| Chairman of the Board, Marie Roskrow | Tel: +44 (0) 7496 959 743 marie.roskrow@arcticzymes.com |
| CFO, Børge Sørvoll | Tel: +47 952 90187 ir@arcticzymes.com |