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Aug 25, 2023

Evolving Healthcare: Mitchell Gonzales At Bisnow’s Denver Healthcare And Life Sciences Summit On June 28

New regulations, including the recent Annex 1 final revision, are compelling

New regulations, including the recent Annex 1 final revision, are compelling life sciences spaces to modernize their supply chain facilities. Cleanroom design and product technologies, in particular, have emerged as a high-value option to help new and existing production facilities align with current regulatory standards while better protecting patients from inadvertent contamination.

The cleanroom technology industry is a $4B industry and is projected to expand at a rate of 5.4% globally by 2028. The city of Denver, in particular, has emerged as a technology hub that is not only creating state-of-the-art production facilities, but universities like MSU Denver are developing better life sciences education programs to help fill the city's pipeline of skilled healthcare professionals.

AES Clean Technology, a design, manufacturer and build provider of modular cleanroom construction, equipment and products for medical and life sciences facilities, is working to help Denver further expand its healthcare footprint. AES Vice President of Process Technology Mitchell Gonzales says nurturing and growing a skilled life sciences workforce is strategically imperative in sustaining Denver's growth.

"We need to be more deliberate in engaging emerging young professionals entering college about the prospects of a rewarding career in life sciences, which is needed to ensure a robust workforce required for this advanced technology field," Gonzales said. "From having designers, scientists and technologists who create these facilities to healthcare production technicians and leaders who operate these facilities in producing lifesaving products for patients."

Gonzales will speak at Bisnow's Denver Healthcare and Life Sciences summit on June 28. Register here. Bisnow spoke with Gonzales about the company's role in expanding Denver's healthcare footprint and what AES sees for the future of healthcare and life sciences in Denver.

Bisnow: What inspired you to speak at Bisnow's Denver Healthcare and Life Sciences Summit?

Gonzales: While I have 30 years in the biopharmaceutical manufacturing industry, I hope to get more in front of the conversation for Denver's healthcare industry. Bisnow has a great event platform to assist communities in connecting to specific industries.

I want to learn more about what the life sciences industry is doing in Denver in assessing modular cleanroom designs and more effective facility solutions in the biopharmaceutical industry. Also, I think this event could be used as a forum to create a better understanding of what clients need for the build-out of life sciences facilities, including the use of modular technologies to deliver high-quality facilities under accelerated time frames.

Bisnow: What topics will you cover at the event?

Gonzales: Some things I want to cover include the challenges of capital projects, such as compliance, design and construction integration and manufacturing hurdles. Also, I’m curious to see the newest medical technologies coming out of Denver's life sciences industry. What are the new industry standards for cleanroom designs and how are they being incorporated into different facilities, especially those for procedures using advanced therapy medicinal products?

Bisnow: Can you describe your role at AES Clean Technology and any projects you’re working on?

Gonzales: I’m the vice president of process technology. In this role, I am responsible for creating conceptual designs for our clients’ cleanroom facilities, whether that be for new greenfield sites or expansion of existing facilities. My team develops the key deliverables that define the needs of the facility, including scoping the projects, rationalizing cost estimates, creating fast-track schedules and even future-proofing the facilities to accommodate future production and process changes.

The upfront conceptual design work that my team performs then feeds a turnkey cleanroom project execution, including detailed design, modular fabrication, on-site installation and commissioning to bring the facility to life. We find that our clients trust us to perform via this turnkey project methodology because we have over 35 years of experience and technical expertise dedicated to cleanrooms for the life sciences industry.

Specialty healthcare and life sciences facilities require high-performance environmental control systems and specialty architectural systems to combat contamination and protect the processes that are occurring inside the space.

Bisnow: What are some of the ways that AES is helping to expand Denver's healthcare footprint?

Gonzales: One of the ways to expand Denver's healthcare footprint is to increase the knowledge on cleanroom facilities as they relate to life sciences. This should start by engaging the community, which takes knowledge, leadership and infrastructure to build. The life sciences industry is a technology-based and highly regulated field, so it's important to instill a local level of industry access, and new production biopharmaceutical facilities is a great approach to this goal.

Bisnow: What is AES’ philosophy on cleanroom technology to help life sciences production facilities function optimally and compliantly?

Gonzales: We have a more hand's-on boutique service approach, which makes us more accessible to clients. By owning the factory that builds our pharma system modular product, we have a full-service design and build cleanroom capability allowing clients to trim costs while isolating execution accountability. Whether we use our Litebeam LED cleanroom lighting system to provide a more flexible approach for locating HEPA diffusers relative to a process, or we prefabricate a gas utility piping system with our Omni Utility Raceway that works well for newer facilities, we create high-value adaptable products that provide process flexibility and facility sustainability.

We’ve been raising the compliance standard with our fit-for-purpose modular panel systems that uses a honeycomb metal frame with uPVC exterior surface that is "assembled" and installed at the site, rather than the outdated and costly cut-and-place gypsum board method, which inherently induces product quality risk during aseptic processing. We are continuing to develop modern modular cleanrooms with new materials and products, reducing cost and timeline while increasing quality and flexibility.

Litebeam LED cleanroom lighting system and Omni Utility Raceway are trademarked by AES Clean Technology.

This article was produced in collaboration between Studio B and AES Clean Technology. Bisnow news staff was not involved in the production of this content.

Studio B is Bisnow's in-house content and design studio. To learn more about how Studio B can help your team, reach out to [email protected].