Founded in 2016, Nucleus Biologics is expanding its San Diego footprint to support the rapidly growing life sciences industry in the region and beyond. The new 19,884 square foot facility includes four liquid and two powder cleanrooms built to ISO 7 specifications for cell media manufacturing, increasing total manufacturing capacity to 2.5 million liters a year. In addition, the new facility will have a state-of-the-art WFI spec water system with ozone sanitization and real-time quality monitoring.
“This is an exciting time for Nucleus Biologics. We have seen rapid growth in both the cell and gene therapy industry and our business and are expanding manufacturing and cleanroom capacity to support our therapy customers to speed the time from discovery to cure,” said David Sheehan, Founder and CEO of Nucleus Biologics. “We are excited to share this achievement with the San Diego business community, local leaders, and our biotech and pharma customers.”
This ribbon cutting comes a month after the company achieved its ISO 13485:2016 certification for the manufacture and distribution of media for the cell and gene therapy industry, further demonstrating the company’s commitment to supporting the stringent quality needs of the life sciences ecosystem.
“An expert in cell science, Nucleus Biologics enables its customers to cure disease and change lives,” said Nikia Clarke, senior vice president of San Diego Regional EDC, who joined the company’s ribbon cutting. “EDC is proud to support the company and its team in continued growth and success in the San Diego region.”
“Nucleus Biologics is a prime example of innovation rooted in purpose,” said Joe Panetta, president and CEO of Biocom California. “This new facility will allow Nucleus Biologics to continue its vital contributions to the cell and gene therapy industry with increased efficiency and capacity, providing customers with the products they need to achieve scientific breakthroughs that save lives. Biocom California is proud to support Nucleus Biologics in our shared commitment to serve those who work tirelessly to accelerate progress in the prevention, diagnosis, and treatment of disease.”
Over the past year, Nucleus Biologics has expanded its staff to 70 employees, signed a collaboration agreement with Cytiva, formerly GE Healthcare Life Sciences, and became an authorized distributor of Stoic Bio’s Krakatoa™ – the first pod-based cell culture media maker that reduces the CO2 emissions of cell culture media by 65% over conventional media. Stoic Bio is a spinoff of Nucleus Biologics.
About Nucleus Biologics
Nucleus Biologics 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.