Mirus Bio Receives ISO 13485:2016 Certification

2024-01-31

基因疗法

Completion of this comprehensive certification process underscores the quality of the processes used to support the company's GMP product portfolio MADISON, Wis., Jan. 31, 2024 /PRNewswire/ -- Mirus Bio LLC, a life sciences company developing innovative solutions for nucleic acid delivery to support cell and gene therapy production, biopharmaceutical manufacturing, and research applications, today announced that its quality management system (QMS) has achieved ISO 13485:2016 certification. "I'm incredibly proud of our team for successfully completing the rigorous process to receive ISO 13485 certification for our GMP product portfolio," said Jena Lange, Director of Operations at Mirus Bio. "This milestone verifies that we have developed and implemented a robust customer centric QMS which reflects our commitment to meeting the needs of cell and gene therapy customers as a trusted partner." The ISO 13485:2016 standard was developed by the International Organization for Standardization (ISO). Receipt of this certification confirms that Mirus Bio demonstrates the management of its organization meets the framework and principles established by the ISO 13484:2016 Medical Device Standard. This is achieved by efficient processes to deliver effective products while complying with applicable regulatory and statutory requirements. "Across our organization, we are intensely focused on achieving the highest standards of quality," said Dale Gordon, CEO of Mirus Bio. "Earning this internationally recognized certification, through a rigorous process led by our QA team, is a collective achievement of all our employees." About Mirus Bio Mirus Bio is a leading provider of transfection products for the biopharmaceutical and research industries, offering best-in-class reagents for gene therapy, recombinant protein, and stem cell applications. A pioneer in nucleic acid delivery, the company has been enabling scientific research and innovation for more than two decades. In 2021, Mirus introduced VirusGEN® GMP Transfection Reagent and Enhancers to address the commercial biopharmaceutical and cell and gene therapy markets with support for virus manufacturing, gene editing, and biotherapeutic protein production. For more information, visit or follow us on LinkedIn.

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机构

Mirus Medical