Solving the Unique Challenges of Life Sciences Manufacturing
David Frank
Image courtesy of Azzur Group
Early-phase manufacturing facilities may require sudden cleanroom access—not always possible with the time and budget available. On-demand cleanrooms offer a quick solution for labs which need controlled environments and a fast turnaround time.
Lab Design News spoke to David Frank, vice president of client development at Azzur Group, about on-demand cleanrooms and their benefits to easy-phase manufacturing.
Q: What is the process behind designing and building an on-demand cleanroom? How does the project get started?
A: Contrary to some misapprehensions, Azzur’s Cleanrooms on Demand™ (COD) are not build-to-suit. Instead, the company operates a suite of cleanrooms with standard cleanroom equipment in areas of the US with the greatest demand for such life sciences facilities. We provide additional available cleanroom space for companies that need to scale up quickly or may not be able to afford the time and expense to build out their laboratory facilities. The facilities utilize a modular panel-based cleanroom system that allows rooms to be reconfigured and tailored to meet the demands of different manufacturing and development processes.
In addition to these on-demand cleanroom facilities, Azzur Group’s COD model offers cGMP support, including materials management, storage, asset management, and supply chain solutions. This allows life science manufacturers to focus on science and cGMP manufacturing without the expense of facility ownership and maintenance.
Most of Azzur’s early-phase manufacturing clients face the same kinds of challenges:
Need for clinical manufacturing capability
Lack of GxP expertise
Limited quality management systems
Lengthy facility design-build timeframes
Insufficient warehouse and materials storage
Q: What prompted you to offer on-demand cleanrooms?
A: The Azzur Cleanrooms on Demand™ business model came about in 2016 when Azzur Group’s client base in Cambridge, MA, encouraged the company to create cleanroom facilities with state-of-the-art GMP manufacturing capabilities in locations where demand for such facilities has long outstripped supply. The goal was to help accelerate critical therapies through the clinic and into the hands of the patients who so desperately needed them. We opened our first site in 2018.
Azzur Cleanrooms on Demand™ operates four cleanroom facilities, with established locations in Raleigh, NC, Waltham, MA, Burlington, MA, and Vista, CA. Construction of new Cleanrooms on Demand facilities is underway in Alameda, CA, and Devens, MA. Each location has been selected for its proximity to established or growing life sciences business areas. Azzur Group plans to open additional Cleanrooms on Demand facilities in locations across the US over the next several years.
This solution has offered much-needed relief in the current economic downturn for the life sciences industry. Belt-tightening and flattening valuations have prompted companies to pursue financial risk management strategies to protect their cash positions. Cleanrooms on Demand enables companies to continue doing their core work without drastically depleting their cash on hand.
Q: What are the challenges associated with designing and building a controlled environment such as this?
A: With any controlled environment, the standard challenges of contamination control, monitoring, mechanical upkeep, and physical plant maintenance are wrapped in cGMP compliance. Azzur Cleanrooms on Demand™ facilities are multi-tenant, multi-product, and multi-modal. As a result, we need to take extra care to eradicate cross-contamination concerns, have enhanced security protocols, and ensure the spaces are designed and operated to the highest standards.
Our 30+ years of working with clients on selecting, designing, building, and operating their facilities around the globe gave us the foundation to pursue the opportunity of building and operating our facilities. From there, it was choosing suitable suppliers and partners to provide the infrastructure, materials, and know-how to enable us to bring these facilities online.
Q: When you plan a kickoff meeting with your client, which project team members/job titles are involved and what are the main issues discussed?
A: During a client kick-off meeting, we spend significant time fully understanding the needs and demands of the client’s manufacturing process. This is particularly important in the Cleanrooms on Demand model because we are not only providing the space to operate in, but we are also providing the cGMP compliance services a client would otherwise have to hire in-house. We explore questions like: What equipment will be needed? How many operators will be in the space? Will there be any need for special accommodations arising from your particular process? What are your storage needs? Those answers will help determine the space and resources necessary for production. With a plan in place, production growth and scalability are made easier, as is speed to start-up. Cleanrooms can be expanded and adapted as requirements change, but having these answers up front makes it easier overall to prepare for any projected increased demand. A typical client can be producing clinical batches six weeks after contacting Azzur.
In terms of “who is involved,” it varies widely based on the size and structure of the company. In smaller organizations, we see C-suite members (CEO, CTO, CSO) along with individuals who run manufacturing, quality, and logistics. In larger (Fortune 500) organizations, we tend to work with cross-functional project-specific tiger teams on developing the scope and deliverables.
Q: Do you need to bring in any outside experts such as engineers, construction, etc., or is everything done in-house?
A: When a Cleanrooms on Demand facility is ready to take on clients, the general engineering and construction have already been completed. At that point, clients work with Azzur Group’s operations experts on facility fit to ensure that the facility is properly set up for the manufacturing and development work to be done.
Q: What are the class ratings of your cleanrooms [I think I saw ISO5-7 in the video?], and how do you work with your clients to determine what class rating is needed? Does the design/build process differ according to the class rating?
A: Azzur’s Cleanrooms on Demand uses International Standards Organization (ISO) classifications. Our standard cleanroom configuration leverages ISO 8 corridors, anterooms, and airlocks that step down into an ISO 7 manufacturing environment. Additionally, rooms are equipped with ISO 5 biosafety cabinets. These standards are typically adequate for early phase (1&2) clinical production and assembly.
As client processes dictate, we can modify the cleanrooms and/or create sub-environments that would bring the spaces to an ISO 5 classification more suitable for late phase and commercial manufacturing and align it with EU standards. This includes additional design elements such as enhanced filtration and air changes, and differential pressure modifications, among several other considerations.
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Image courtesy of Azzur Group
