ISO 13485 Certificate
Alphazyme has been awarded certification to the ISO 13485:2016 Quality Management System (QMS) standard by British Standards International (BSI).
Founded in 2018, Alphazyme produces a growing portfolio of enzymes used by the firm’s business partners in the fields of molecular diagnostics and nucleic acid drug development. According to Chris Benoit, CEO of Alphazyme, “through PCR tests and mRNA vaccines, the global pandemic ushered “genetic literacy” to the forefront of medicine. The enzymes that Alphazyme produces are the molecular motors that enable the interpretation, alteration, and authorship of genetic code.
A strong Quality Management System is central to Alphazyme’s ability to support these technologies, and we are thrilled to announce that with this certification, we’ve achieved the first step in our Quality roadmap.” Stephana Petrino, VP of Quality, and the architect of the QMS, added “We selected ISO 13485 as the foundation of Alphazyme’s QMS based on its relevance to our molecular diagnostic industry partners and the Standard’s alignment, as a QMS, with the FDA’s ICH Q10 guidelines for pharmaceutical manufacturing. The team has worked diligently since our inception to build this system, and we completed the Certification audit process with zero major non-conformities – a testament to the culture of Quality here at Alphazyme.”
The ISO certification caps off an intensive period of infrastructure investment for the company. Chad Decker, COO, commented “The enzymes that author nucleic acids have never been produced in accordance with pharmaceutical regulations. Alphazyme was founded to address the gap between molecular biology enzyme production and the Quality and regulatory requirements of emerging, highly regulated use cases for these products. We have redesigned these methods and implemented them in a purpose-built facility governed by a high-traceability Quality System – and we are excited to engage with genomics industry to understand and meet expectations for these critical products.”