Azzur serves NC biosciences with “Cleanrooms on Demand”
This article originally appeared on the NCBiotech website and was written by Jim Shamp, NCBiotech Writer. Azzur Cleanrooms on Demand (COD) has opened a 75,000-square-foot facility in Morrisville, NC, offering flexible cleanroom and lab space to help life sciences startups accelerate product development and manufacturing while maintaining full control over their IP and processes.
A national life sciences service company is providing North Carolina startups with new options for unlocking space for turnkey product development and manufacturing facilities in Morrisville.
Azzur Cleanrooms on Demand (COD) has entered this acronym-laden environment to provide cleanroom and laboratory spaces for so-called GxP manufacturing support. Opened in May 2023, it’s a 75,000-square-foot rebirth of a former Sam’s Club site at 1101 Shiloh Glenn Drive in the Raleigh suburb.
GxP is an acronym that refers to widely accepted “good practice” guidelines and regulations designed to ensure that products such as food, medical devices, and drugs are safe, effective, and usable. The ‘X’ is used in GxP to encompass a variety of disciplines: GMP (Good Manufacturing Practices); GDP (both Good Documentation Practices and Good Distribution Practices); GLP (Good Laboratory Practices); and others.
“X” marks the spot in GxP where companies in regulated industries can control their processes, procedures, people, and premises to ensure product consistency and quality. According to Nick Mazzucca, the Boston-based vice president of sales and marketing at the parent company, Azzur Group, Azzur originally developed an especially sweet spot around 2017 with the COD business model.
Azzur offers a wide range of “wraparound services” at the Research Triangle-area site, including GMP cleanroom environmental monitoring, materials management and storage, equipment management, and supply-chain solutions. The company showcases these services in a video here.
Azzur Group is a privately held network of companies founded in 2010 in the Philadelphia suburb of Hatboro. It provides consulting services to life sciences companies, including project management, facility solutions, engineering, validation, information technology, calibration, and maintenance.
Mazzucca said the COD concept evolved from meeting a client's need.
“An Azzur consulting client was looking for GMP manufacturing space for their people to perform their own internal processing. They wanted to protect their intellectual property and keep control of their timelines rather than going to a CMO (contract manufacturing organization).
“Our team said, yeah, we can make this work. So, they got a facility set up with a few cleanrooms for GMP manufacturing, and it worked out really well. Then our team said, ‘Hey, this could be a really interesting business model that's different from building your own facility or partnering with a contract manufacturer.’
“So that's where our Cleanrooms on Demand concept got started. And it has continued to grow over the years. We now have three facilities in Massachusetts and this one in North Carolina, to provide these wraparound GxP services in biopharma clusters along the East Coast of the U.S.”
Mazzucca said the COD model offers some of the things available from some CDMOs (Contract Development and Manufacturing Organizations), except for the manufacturing. And it adds significant benefits.
“I think the main value proposition that we try to communicate to our clients is that you still get to own the process. You get to own the IP (intellectual property), your timeline, whatever risks you choose to take as part of your own internal development and manufacturing. It's a lot of ‘take what you need from us and nothing you don’t’ versus a CDMO where it's typically, ‘Here are our people, they do the development and manufacturing for you, this is our platform, and here is the price.’ With us, you get to keep your technology, your platform, and your IP. No one else is doing the processing for you.”
One of Azzur's cleanrooms.
Mitch Gore, Ph.D., Azzur’s business development manager working remotely from Pennsylvania, further explained during an interview with the North Carolina Biotechnology Center (NCBiotech) how Azzur’s COD offering is different from traditional CDMOs.
“The type of clientele that could really benefit from the COD model are usually in their earlier stages,” noted Gore. “Their main currency is time. They need to get something done. They don't really want to spend time on the process transfer. They don't want to risk their IP at that stage of the game. For sure, they want to find a way to do it less expensively than what they’d face with a buildout.
“There's this whole class of customers that the traditional big CDMOs can't handle because they're just not a good fit. It would take too long or it would be too expensive. So that's one of the reasons I joined COD. I've spent a few years turning down the kinds of customers that are perfect fits for us. And I saw opportunity here.”
He said about 45 people work at the Morrisville campus, some drawing paychecks from Azzur and some employed by client companies licensing COD spaces from Azzur. The site has 24 cleanrooms, each 750 square feet, which can be combined to fit clients’ needs.
“Azzur’s assets and capabilities provide another avenue for life sciences companies to mature and scale in North Carolina,” said Laura Rowley, Ph.D., vice president of the Life Science Economic Development group at NCBiotech.
