ISO 13485:2016 certification demonstrates Nucleus Biologics’ commitment to maintaining premium quality standards.
(San Diego, CA – August 23, 2022) Nucleus Biologics, The Cell Performance Company™, the industry-leading provider of small lot custom media for the cell and gene therapy industry announced today that it has been granted ISO 13485:2016 certification from BSI for the manufacture and distribution of media for the cell and gene therapy industry. BSI is among the largest, most reputable and experienced management systems certification bodies in the world, with more than 35,500 registrations worldwide.
ISO 13485 is the industry standard for quality management systems regulating medical devices and related services that ensures the quality of a product’s design, development, and production consistently meet customer and applicable regulatory requirements. The International Organization for Standardization (ISO) is an international nongovernmental organization that publishes and governs a wide range of standards to ensure the safe, reliable, and quality production of products.
“This milestone is the result of years of effort to extend our leadership in custom cell culture media for the cell and gene therapy market,” said David Sheehan, Founder and CEO of Nucleus Biologics. “Now, therapy developers have one partner that can offer everything from formulation development support to cGMP 2,000-liter media manufacturing — all governed by strict adherence to the ISO 13485 level quality system. Our history of product innovations, quality, and collaborations will only expand as we help our customers speed the time from discovery to cure.”
Cell culture media is a critical raw material for the development of cell-based therapies. With ISO 13485:2016 certification, Nucleus Biologics is well positioned and committed to supporting cell and gene therapy development with the manufacturing and delivery of media products that meet the highest standards for quality, product performance, and reliability.
About Nucleus Biologics
Nucleus Biologics, The Cell Performance Company, is the leading provider of custom cell-growth media, tools, and technologies for cell and gene therapy. Its mission is to speed the time from scientific discovery to cure by delivering innovative, transparent, and cGMP products and services with the goal of disrupting the market and eliminating antiquated practices and products. Ultimately, Nucleus Biologics strives to create a new paradigm that serves both scientists and clinicians, while reducing the environmental footprint of cell culture.