Nucleus Biologics Receives Int’l Certification

Nucleus Biologics has received a stamp of approval for its custom cell culture media for the gene and cell therapy industry.

On Aug. 23, the company announced it had been granted ISO 13485:2016 certification from international management systems certification body BSI. ISO 13485 is considered 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.

“It’s a pretty big stamp of approval from an international body,” said Nucleus Biologics founder and CEO David Sheehan. “Anybody manufacturing cell therapies anywhere in the world can know we have a quality system that outputs a product that meets those standards.”

Sheehan said the certification is especially important for producers of cell culture media – essentially the “liquid food” used to grow cells for therapeutics – because the FDA doesn’t regulate the industry.

“They regulate the final product, which is the cell or gene therapy, and then it’s up to the therapy developer to manage their supply chain, make sure the quality standards are mets so that they can complete their regulatory filings with FDA,” Sheehan said, adding that the ISO (International Organization for Standardization) certification is a way to meet the needs of therapy developers and “speed the time from discovery to cure.”

Therapy developers’ need for cell culture media is growing quickly. According to a report by the Alliance for Regenerative Medicine, in the first half 2021 there were 1,320 industry-sponsored and 1,328 non-industry sponsored regenerative and advanced therapy trials underway worldwide. By 2026, the report forecast there will be 3,100 unique therapies in development.

“We’re moving away from an era where you’re taking a pill. Now, it’s becoming either a cell therapy or some kind of viral vector that’s carrying a gene of interest into your body,” Sheehan said. “What is unique is that all those products require media and that media has to be made in a clean environment. It has to be sterile and it has to be very well characterized and there needs to be a certificate of analysis. That’s the future.”

‘Almost Like Amazon’

The ISO certification is just the latest example of how Nucleus Biologics has been preparing for the future this year.

In January, the company signed a collaboration agreement with Cytiva (formerly GE Life Sciences) on custom media formulation and fulfillment solutions for the cell and gene therapy industry.

The agreement gives Cytiva customers access to Nucleus Biologics’ proprietary artificial intelligence platform for optimizing cell culture formulations, and a cell media configurator that enables customization of cell culture media while maintaining formulation ownership, in addition to ordering “off-the-shelf” cell culture media.

“One of Cytiva’s strengths is our ability to collaborate with other organizations to bring our customers the most innovative solutions,” said Catarina Flyborg, vice president of cell and gene therapy at Cytiva. “Our collaboration with Nucleus Biologics is a primary example of this. Together, we will provide our customers with solutions that will accelerate the development of cell and gene therapies.”

Sheehan described the NB-AIR and NB-LUX systems as “almost like Amazon of media.”

The platforms allow researchers or pharma companies to select standard media types or customize the formula and includes powerful tool like access to databases of information on various cell types and their media needs.

“You can go in and say, ‘What attributes do I want out of that cell type?’” Sheehan said.

If a researcher wants T-cells to hunt down cancer and needs them to be cytotoxic, NB-AIR will show all the components in the published literature that have an impact on cytotoxicity, an impact score and links to the published articles in PubMed. “You can go through this process and then select what is the most cited media and add components to it and start to create your own formula.”

Once the media is created, customers pick a size and a container type and then add to a shopping cart, pay and wait for delivery.

Cell Media Innovators

Also this year, Nucleus Biologics announced the launch and distribution of Krakatoa − “the world’s first point-of-use media manufacturing machine,” Sheehan said. Krakatoa is manufactured by Stoic Bio a sister company that Sheehan heads as well.

Krakatoa is a self-contained unit that allows customers to produce their own cell culture media right in their own labs. The media is prepared into a powder and sent in recyclable pods which are inserted into the machine, solubilized and dispensed into reusable bottles. “Basically, it’s like an Nespresso machine for cell culture media,” Sheehan said.

Nucleus Biologics’ string of accomplishments this year have meant additional recognition form the cell therapy industry.

“It put us on the map because people now see us as innovators,” Sheehan said. “We’re the first ones into the market with an AI-based platform for formulation, the first with a cloud-based portal for ordering media and now we’re the first ones into the market with a pod-based media manufacturing system.”

Nucleus Biologics, LLC
Founded: 2016
CEO: David Sheehan
Headquarters: San Diego, Rancho Bernardo
Business: Custom media supplier in gene and cell therapy space
Employees: 70
Website: www.nucleusbiologics.com
Notable: Nucleus Biologics’ Krakatoa is the world’s first point-of-use media manufacturing machine.