Tromsø, Norway, June 29[th] 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