Azzur opens new on-demand cleanroom facility in California

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(Image: Azzur Group)

The company’s Azzur Cleanrooms on Demand division has established another facility in Vista, a city in the San Diego Area, for life-sciences operations.

Azzur Cleanrooms on Demand (a division of Azzur Group) has opened the doors on its latest facility in Vista, California. The facility is the second location, joining the first location that opened in 2018 in Waltham, Massachusetts.

In addition to cleanroom facilities. The Cleanrooms on Demand model offers early-stage life-sciences clients materials management, storage, asset management, and supply chain solutions. The facilities are intended to enable clients to focus on research and early-stage Current Good Manufacturing Practice (cGMP) manufacturing, without the heavy investment associated with ownership and maintenance of such infrastructure. cGMP manufacturing without the burden of facility ownership and maintenance.

The Vista facility features 30,000 square feet of space, including 11 separate cleanrooms, onsite storage, and laboratory space; it is adjacent to Azzur Labs, providing clients access to more comprehensive services. Ravi Samavedam, Azzur Cleanrooms on Demand president, said significant growth in several life-sciences sectors has led to an increased need for such capabilities.

“With the explosive growth in novel therapeutics, such as cell and gene therapy and microbiome-based therapies, the Azzur Cleanrooms on Demand business model is poised to accelerate time to clinic and market for such products in key biotech clusters, including San Diego,” Samavedam said.

Michael Khavinson, CEO of Azzur Group, told Outsourcing-Pharma said the COVID-19 pandemic impacted the company, moving its leaders to take a fresh look at how the company operates (internally and externally), and how it serves its clients.

The pandemic shed some light on the industry in a positive way, in terms of how therapies are developed and manufactured – not just in the case of COVID, but across the board,” Khavinson said. “From that standpoint, it brought more focus to processes in the industries we serve.

Samavedam added that the virus created challenges for Azzur Group businesses, it also has led to opportunities.

While the pandemic did cause disruption in its early days, we are clearly seeing an uptick in activity now – not only from vaccine research and development but also in areas such as testing and diagnostics as well,” he commented. “We’re seeing very encouraging growth in the Cleanrooms on Demand side of the business; our offering provides a middle option between building a facility, which can be costly and time-consuming, or taking on CMOs/CDMOs, which in many cases have a long waitlist to serve new clients.

Brett Tucker, partner with Baird Capital (the private equity firm backing Azzur Group’s expansion efforts) said the firm decided to invest in the company after conversations and “rigorous” evaluations.

We spoke to many customers, competitors, industry participants throughout the process; our findings showed that Azzur delivers high-quality work and services to their consulting clients, and they have a great reputation in the market,” he told OSP. “We also learned that there is a great need for their Cleanrooms on Demand offering—biotech companies don’t have the capital or risk appetite to build their own facility, and they don’t want to transfer their process know-how to a CMO/CDMO. The COD offering is a hybrid that avoids those three problems for promising biotechs.”

And, considering the industry growth trend is anticipated to continue, Azzur Group is planning on additional facilities and expansion in the future, Samavedam told us.

“In terms of expanding our services, we will be adding capabilities in the offices we established through 2019 and 2020,” he told us. “We plan to build labs, training centers, and possibly additional Cleanrooms on Demand sites in some of these locations; we’re always considering ways to expand our services into the markets that are making a difference in the pharmaceutical development and manufacturing industries.”