In June 2025, CATUG has successfully passed an audit by a European Union Qualified Person (QP) and received the official compliance report. This milestone confirms that CATUG’s quality management system and manufacturing capabilities fully comply with EU GMP standards, supporting the high-quality production of plasmid DNA, RNA(mRNA，circRNA，saRNA), and Non-viral vector delivery (LNP,LNP-Ab,etc.).

The three-day audit was conducted by a UK QP with over 20 years of experience in the pharmaceutical industry. The assessment covered EU GMP Annexes 1, 11, and 15, ICH Q7, 21 CFR Part 11, and ISO 13485. Key areas reviewed included quality systems, production processes, sterile controls, facilities, personnel, documentation, and utilities.
 

The auditor highly praised CATUG’s  quality culture, professional team, and high level facilities. The successful audit highlights CATUG’s commitment to global quality standards and its capabilities as a reliable partner in the field of nucleic acid and LNP manufacturing.
 

Building on this achievement, CATUG will continue to enhance its R&D and quality systems to deliver efficient, high-standard services to clients worldwide.