E S T. 1 9 8 6 · C E L E B R AT I N G 4 0 Y E A R S
WATC H T H E A E S STO RY
Qualifications Package I N T E G R AT E D C L E A N R O O M D E S I G N · M A N U FAC T U R E · B U I L D · S E R V I C E Life Sciences · Biopharma · Advanced Technology
Together, we build tomorrow.
INSIDE THIS PACKAGE
Contents
40
Y E AR S O F C L E A N R O O M EXC ELLEC E
17
IS P E FAC I L I T Y O F T HE YEAR H O NO RS
3,000+
FACI L I T Y B U I L DS DE L I VERED
01
Company Profile
02
The Single-Source Advantage
03
Faciliflex
04
Cleanroom Experience
05
Client History
06
Our Execution Approach
07
The Integrated Method
08
Keys to Success
09
Quality Management
10
Safety & Workforce
11
System & Certifications
12
Integrated Technologies
13
AES +Care Service Plan
14
Our Work
Overview & brand film. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Vertical integration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Turnkey cleanroom solution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Track record.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Selected relationships. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Compass to commissioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Define · Design · Develop · Deliver.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
How we deliver certainty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
ISO 9001:2015 aligned system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Certification, training, oversight. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
FM Approved panels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Omni · Litebeam · Infinity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Preventative maintenance program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Project profiles & experience. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
AES CLEANROOM TECHNOLOGY
|
Qualifications Package
2
01
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C O M PA N Y P R O F I L E
Dedicated to cleanrooms since 1986 As one of the most recognized and largest US-based cleanroom companies, AES has spent 40 years perfecting a single discipline: the design, manufacture, construction, and commissioning of cleanroom facilities for the life sciences. Our work spans cell and gene therapy, biologics, aseptic fill-finish, pharmaceutical and API manufacturing, medical device, and advanced technology environments. Millions of square feet of validated GMP space built by AES are in operation today, compliant with ISO, FDA, and EU standards.
40
3,000+
YEARS EXPERIENCE
PROJECTS DELIVERED
Our Mission To minimize our clients’ risk in deploying their facility program so that life-changing therapies reach patients, while they stay focused on their science.
7.5M+
S Q . F T. CONSTRUCTED
17
100%
F O YA H O N O R S
MADE IN THE U N I T E D S TAT E S
Our Promise
Our Goal
You come first. Your requirements, your schedule, and your budget drive our team. We are built to meet and exceed your expectations.
To build lasting relationships through successful projects. That is why the quality and safety of your project are always our highest priorities.
WHY OUR CLIENTS CHOOSE US AGAIN AND AGAIN Integrity drives everything we do, because your success depends on partners you can trust completely. Our reputation is proven through decades of repeat business with clients who return to us project after project. We look beyond the specifications to deliver long-term value: reduced lifecycle cost, greater operational efficiency, and the confidence that comes from partnering on your most critical facilities.
WATC H O U R S TO R Y
OUR STORY
The AES Story
Four decades of cleanroom focus, and the people behind it. See who we are and how we partner with the leaders of advanced therapy. youtu.be/ 7E2PfkEFvVM
WATC H
AES CLEANROOM TECHNOLOGY
|
Company Profile
S C A N T O WAT C H
3
02
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THE SINGLE-SOURCE ADVANTAGE
One accountable partner, from concept to operational readiness While others coordinate multiple vendors and manage complex supply chains, AES self-performs design, manufacture, and installation under one roof. We design the cleanroom, fabricate the modular system in our own US factories, construct the facility, and commission the scope. That single-source model gives you unprecedented control over quality, timeline, and cost: no scope gaps between phases, one point of accountability, and continuity that directly reduces your risk.
01
02
03
04
DESIGN
M A N U FA C T U R E
BUILD
COMMISSION
In-house architects and engineers develop compliant, constructable facility designs.
The AES Modular Cleanroom Wall and Ceiling System, built to spec in the USA.
A dedicated national construction team installs on spec, on time, on budget .
We commission what we design and build, accelerating validation and startup.
YO U R P E AC E O F M I N D, T H R O U G H P R OV E N I N T E G R AT I O N
Single Point of Accountability
Guaranteed Continuity
Innovation Advantage
Seamless coordination with clear accountability across every phase.
Your dedicated team and manufacturing capacity, from start to finish.
Proprietary technologies designed with your business in mind.
S E E I T B U I LT MANUFACTURING
Off-site Manufacturing & Prefabrication Watch the AES Modular Cleanroom Wall and Ceiling System take shape in our own US facilities, the source of our single-source control. youtu.be/S8WUA8QTkZ0
WATC H
AES CLEANROOM TECHNOLOGY
|
The Single-Source Advantage
S C A N T O WAT C H
4
02
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THE SINGLE-SOURCE ADVANTAGE
One accountable partner, from concept to operational readiness While others coordinate multiple vendors and manage complex supply chains, AES self-performs design, manufacture, and installation under one roof. We design the cleanroom, fabricate the modular system in our own US factories, construct the facility, and commission the scope. That single-source model gives you unprecedented control over quality, timeline, and cost: no scope gaps between phases, one point of accountability, and continuity that directly reduces your risk.
01
02
03
04
DESIGN
M A N U FA C T U R E
BUILD
COMMISSION
In-house architects and engineers develop compliant, constructable facility designs.
The AES Modular Cleanroom Wall and Ceiling System, built to spec in the USA.
A dedicated national construction team installs on spec, on time, on budget.
We commission what we design and build, accelerating validation and startup.
YO U R P E AC E O F M I N D, T H R O U G H P R OV E N I N T E G R AT I O N
Single Point of Accountability
Guaranteed Continuity
Innovation Advantage
Seamless coordination with clear accountability across every phase.
Your dedicated team and manufacturing capacity, from start to finish.
Proprietary technologies designed with your business in mind.
S E E I T B U I LT
MANUFACTURING
Off-site Manufacturing & Prefabrication Watch the AES Modular Cleanroom Wall and Ceiling System take shape in our own US facilities, the source of our single-source control. youtu.be/S8WUA8QTkZ0
WATC H
AES CLEANROOM TECHNOLOGY
|
The Single-Source Advantage
S C A N T O WAT C H
4
03
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TURNKEY CLEANROOM SOLUTION
Faciliflex Complete control over your critical processes Faciliflex delivers a complete turnkey cleanroom facility that maintains total control over your critical processes through a secured, stable environment engineered specifically for your science. Our turnkey approach removes the risk of multiple handoffs by providing single-source responsibility from initial design through final commissioning. Faciliflex has supported the growth of biotech and pharmaceutical companies across North America. COMPLETE TURNKEY DELIVERY
DESIGN
INSTALL
MANUFACTURE
COMMISSION
Guaranteed Performance We guarantee your cleanroom will perform across every critical parameter:
Temperature
Humidity
Pressurization
Containment
Eliminate handoff risk
Accelerate time-to-market
Single-source responsibility from design through commissioning.
Proven modular methodology for rapid, predictable deployment.
New build or retrofit
Protect your investment
Cleanliness
Guaranteed performance and regulatory compliance from day one.
Box-within-a-box construction adapts to any host building.
Read the full
Faciliflex Brochure
VIEW BROCHURE
in the AES digital library
AES CLEANROOM TECHNOLOGY
| F a c i l i f l e x Tu r n k e y S o l u t i o n
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04
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CLEANROOM EXPERIENCE
A validated track record across the life sciences AES has designed, built, and commissioned millions of square feet of cleanroom facilities in operation today, producing regulated products across the life science industry. Our completed facilities are regulated by the US FDA, EMA, Health Canada, and the WHO. Most AES clients return to us for multiple projects across numerous locations, and they can speak directly to our record for delivering.
MARKETS WE SERVE Cell and Gene Therapy Pharma & API
Biologics & Biotech
Medical Device Aseptic Fill-Finish Advanced Technology Facilities
Recognized by the ISPE Facility of the Year Awards program on multiple occasions. AES cleanrooms have served as the manufacturing environment for first-of-kind FDA-approved therapies, including Provenge, Luxturna, Kymriah, and Amtagvi.
AES CLEANROOM TECHNOLOGY
| Cleanroom Experience
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05
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CLIENT HISTORY
Trusted by the leaders of advanced therapy 2023
Genentech, CA · Nexus, WI
2022
CRISPR Therapeutics, MA · Catalent, IN Iovance, PA
2021
Perelman Center for Cellular & Molecular Therapeutics, PA · Locus Biosciences, NC
2020
United Therapeutics, MD · Sanofi, MD Bristol-Myers Squibb, Dublin
2019
Takeda, GA
2017
Novartis–Penn Center for Advanced Cellular Therapies, PA · Cook Pharmica (Catalent), IN Bristol-Myers Squibb, MA
2015
Pharmalucence, MA
Most AES clients return for multiple projects across multiple sites. Full professional references available on request.
AES CLEANROOM TECHNOLOGY
| Client History
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06
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OUR EXECUTION APPROACH
A continuous process, from Compass™ to commissioning Our cross-functional team runs a continuous process that starts with Compass, our cleanroom facility programming and cGMP compliance method. Compass arrives at a facility layout that meets your process requirements and complies with the regulations of every jurisdiction where your product will be delivered.
PROGRAM
DESIGN
BUILD
VA L I DAT E
Compass
Detailed Engineering
Manufacture & Install
Commissioning
Engineering documentation for authority review, with live pre-construction cost and schedule feedback.
In-house manufacture of the modular system, then clean, precise field construction with no scope gaps.
Facility conceptualization and compliance planning aligned to your process and target markets.
We commission what we design and build, coordinating protocols with your quality team to speed startup.
Read the full
Compass Brochure
VIEW BROCHURE
in the AES digital library
S E E C O M PA S S I N AC T I O N C O M PA S S
Conceptual Facility Planning WATC H
AES CLEANROOM TECHNOLOGY
See how Compass turns your process requirements into a compliant, fit-forpurpose facility layout, before a single panel is fabricated. youtu.be/efeHWYCB9P8
| Cleanroom Experience
S C A N T O WAT C H
8
06
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OUR EXECUTION APPROACH
A continuous process, from Compass™ to commissioning Our cross-functional team runs a continuous process that starts with Compass, our cleanroom facility programming and cGMP compliance method. Compass arrives at a facility layout that meets your process requirements and complies with the regulations of every jurisdiction where your product will be delivered.
PROGRAM
DESIGN
BUILD
Compass
Detailed Engineering
Manufacture & Install
Engineering documentation for authority review, with live pre-construction cost and schedule feedback.
In-house manufacture of the modular system, then clean, precise field construction with no scope gaps.
Facility conceptualization and compliance planning aligned to your process and target markets.
VA L I DAT E
Commission We commission what we design and build, coordinating protocols with your quality team to speed startup.
Read the full
Compass Brochure
VIEW BROCHURE
in the AES digital library
S E E C O M PA S S I N AC T I O N C O M PA S S
Conceptual Facility Planning WATC H
AES CLEANROOM TECHNOLOGY
See how Compass turns your process requirements into a compliant, fit-forpurpose facility layout, before a single panel is fabricated. youtu.be/efeHWYCB9P8
| Cleanroom Experience
S C A N T O WAT C H
8
07
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THE INTEGRATED METHOD
Define · Design · Develop · Deliver Four disciplines, one continuous team. Each stage carries the project forward without the handoffs and scope gaps that add cost and risk on multi-vendor projects.
Define
HOW WE DEFINE
Design
HOW WE DESIGN
Align scope, schedule, and cost with the project team
In-house architects and engineers
Design-Assist integration to reduce facility cost and risk
Construction Quality Plans used to commission thefacility
Leverage model development and cross-discipline coordination
BIM coordination and 3-D modeling
FPO Develope
HOW WE DEVELOPE
Deliver
HOW WE DELIVER
We are also the manufacturer, minimizing errors before they happen
A dedicated national project and construction team
All components built in our US facilities
Highest industry quality and safety standards
Pre-engineered modular systems that expedite installation
Comprehensive turnover package and dedicated aftercare
AES CLEANROOM TECHNOLOGY
| The Integrated Method
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08
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KEYS TO SUCCESS
How we deliver certainty on every project Partnership Value-effective decisions Quality in every aspect of delivery An overall project-success mindset
Lean Delivery Target Value Estimating Pull-planning Data-driven performance monitoring
Safety A proactive safety culture Assessment, mitigation, and training Safe plan actions and JSAs for every task
Communication Detail coordination between cleanroom and trades BIM clash resolution and no-fly zones Project status reporting via Procore
Cost & Schedule Certainty Early integration with design and pre-con Quantity-based baseline budgeting Dedicated procurement for maximum savings
Logistics Coordinated zoning strategy and sequence Aligned project partners Synchronized just-in-time delivery
T H E R E S U LT : C E R T A I N T Y Every discipline above exists for one reason: to remove risk, delay, and cost overruns from your cleanroom program so your team can stay focused on the science.
AES CLEANROOM TECHNOLOGY
| Ke y s t o S u c c e s s
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09
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QUALITY MANAGEMENT
A quality system aligned to ISO 9001:2015 AES operations are guided by a comprehensive Quality Management System aligned with ISO 9001:2015 principles, ensuring rigorous risk management, precision, and continuous improvement from design through construction and aftermarket support. Four decades of cleanroom construction experience inform every procedure, so quality is built into the process rather than inspected in at the end.
KEYS TO QUALITY
Design & Manufacturing
KEYS TO QUALITY
Construction
Structured Quality Processes
Skilled, Trained Workforce
Clearly defined procedures aligned with ISO 9001: 2015 for consistent results.
Personnel are selected and continuously trained for quality-focused execution.
Client-Centric Standards
Data-Driven Improvement
Focused on meeting your specifications and exceeding expectations.
Structured lessons learned, root cause analysis, and CAPA prevent recurrence.
Independent Design Reviews
Precision Tools & Materials
Stage gates and technical reviews verify critical design requirements.
High-quality tools reduce variability and ensure consistency.
Leadership & Accountability
Protection of Installed Work
Teams are empowered to make quality-focused decisions at every stage.
Project controls and quality gates protect completed work until handover.
Ongoing Training
Rigorous Audits
Continuous skill development reinforces quality principles and best practices.
Regular audits and inspections verify quality and surface improvements.
CORPORATE QUALITY PLAN One quality system spans design, manufacturing, construction, and aftermarket support, so the standards that govern your drawings are the same ones that govern the panel on your wall.
AES CLEANROOM TECHNOLOGY
| Ke y s t o S u c c e s s
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10
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SAFETY & WORKFORCE
Our workforce is our greatest asset Safety and quality are rooted in the expertise and dedication of our people. Every AES field employee meets defined qualification standards, is trained specifically on AES cleanroom systems, and works under our direct oversight. We do not engage third-party labor sources.
OSHA Certified All competent personnel and foremen hold a current OSHA 30 certification. All field installers hold a current OSHA 10 certification.
No Third-Party Labor AES self-performs installation. We do not engage third-party labor sources, ensuring direct oversight, consistent standards, and full compliance with labor laws.
Comprehensive Training Every employee completes an extensive onboarding and apprenticeship program, including specialized training in our proprietary cleanroom systems, with ongoing training throughout their tenure.
E-Verify Compliance AES employs a workforce fully authorized to work in the United States, using the E-Verify system for all new hires.
W H Y T H I S M AT T E R S O N Y O U R S I T E Our installers are trained exclusively on AES systems, so they know every detail of what they are building. That is a meaningful difference from crews who install a rotating mix of third-party products with limited familiarity with any one of them.
S A F E T Y C U LT U R E I N P R A C T I C E Proactive Culture
Safety planned into every task, not added after.
AES CLEANROOM TECHNOLOGY
| S a f e t y & Wo r k f o r c e
Assessment & Mitigation
Hazards identified, mitigated, and trained against.
Safe Plan Actions & JSAs Implemented for all tasks on every project.
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11
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SYSTEM & CERTIFICATIONS
The AES Modular Cleanroom Wall and Ceiling System Your single-source cleanroom system: made in the USA, engineered in detail, and vertically integrated from design through installation. Built for a service life measured in decades.
Quality by Design Vertical integration: design, manufacture, manage, install System-engineered details Thicker-gauge quality materials UL-listed raceways standard 3” uPVC cover corners
Certifications & Approvals FM Approved wall and ceiling panels (FM 4880 Class 1 and FM 4882) ASTM Class A ICC (International Code Council) Proven third-party integration
Proven Lifespan
Lifecycle Support
US cleanrooms in operation for 30+ years Over 3,000 facility builds delivered Tested with cleaning reagents and decon systems Proven repair methods
AES +Care aftermarket and maintenance programs Routine inspection and spare-parts planning Emergency support and scheduled service
N EW: F M 4 8 8 2 A PPR OVED PA NEL S Our wall and ceiling panels have earned FM 4882 approval for smoke-sensitive occupancies, additive to their existing FM 4880 Class 1 fire rating. More specifications are beginning to call for 4882, and there is no retrofit path for any manufacturer.
AES CLEANROOM TECHNOLOGY
| Systems & Certifications
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S U P P LY C H A I N S E C U R I T Y
Panel availability, guaranteed The market is experiencing a historic surge in cleanroom panel demand, straining supply chains and putting project timelines at risk. Long lead times, vendor backlogs, and material shortages are now standard across the industry. Because AES manufactures its own wall and ceiling systems, we offer a level of schedule security that is unavailable through third-party vendors. Once a project is awarded, we lock in production slots to assure delivery.
T H E A E S A D V A N TA G E : I N - H O U S E PA N E L M A N U F A C T U R I N G
How we protect your schedule Guaranteed Production Slots
Factory capacity is prioritized for AES projects. No waiting in line behind other buyers.
Schedule-Driven Manufacturing
Panel production is aligned to your zone-by-zone install plan, so deliveries match field readiness.
On-Demand Acceleration
We control the manufacturing, so we can adapt production timelines to shifting site conditions.
4-Month Rolling Inventory
Materials are maintained proactively to buffer against global shortages.
Elimination of Vendor Risk
No dependency on third parties means no surprises in lead time, quality, or pricing.
Vertical integration is not a talking point here. It is the reason we can commit to a delivery date and hold it when the rest of the market cannot.
AES CLEANROOM TECHNOLOGY
| Supply Chain Security
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INTEGRATED TECHNOLOGIES
Engineered advantages built into the envelope AES develops proprietary technologies that integrate cleanly into the modular system, reducing installation time and cost while raising performance. Scan or tap any product to view its flyer.
Omni Electrical Raceway
Omni Utility Raceway
Omni ASCENT
Power and data receptacles integrated into the vertical wall posts, with wiring pre-installed and terminations above the walkable ceiling.
Up to six inert or non-hazardous gas supplies integrated into the wall posts. High-purity, fully welded 316 stainless steel, leaktested to UHP standards.
Off-site manufactured vertical utility solution positioning utilities off walls and ceilings. Arrives fully assembled and installs in under half a day.
US PATENT 10,968,630
HIGH-PURITY 316 SS
OSM · < HALF A DAY
S CA N OR TAP
SCAN OR TAP
SCAN OR TAP
Litebeam Structural LED
Infinity Glass Wall
CleanLock Module
A structural linear LED that flushintegrates into the 75 mm walkable ceiling. UL listed, IP65, up to 190 lm/W, with amber/ white dualillumination.
High-visibility glass that supports tours and inspections from outside the room, minimizing downtime and contamination risk.
A prefabricated OSM airlock delivered as a fully commissioned room. 3-D modular design with AES finishes, patented lighting, and advanced door controls.
UL LISTED · IP65
STAINLESS RAILS
OSM · COMMISSIONED ROOM
S CA N OR TAP
SCAN OR TAP
SCAN OR TAP
AES CLEANROOM TECHNOLOGY
| I n t e g r a t e d Te c h n o l o g i e s
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AES +CARE SERVICE PLAN
Protect your cleanroom against the unexpected Your cleanroom is one of the most critical assets in your manufacturing process, and any disruption that leads to downtime can derail your entire operation. AES +Care is a preventative maintenance program built to support your routine maintenance and identify potential disruptions long before they become critical issues. When you choose AES, you are partnering with the team that understands cleanrooms from the inside out, whether we built yours or not.
Prevent Unexpected Downtime
Original Manufacturer Expertise
Peak Efficiency Maintenance
20% Discount on OEM Parts
Regulatory Confidence
Regulatory Confidence
Proactive semi-annual inspections catch potential failures before they disrupt operations.
Architectural assessments that maintain cleanliness classifications and extend equipment life.
Audit-ready documentation with detailed inspection reports and CAPA plans.
We don’t just service cleanrooms, we build them. Our technicians know the specs and materials.
Priority pricing on genuine AES components, ensuring perfect fit and performance.
Regular architectural maintenance protects your capital investment from premature degradation.
S EAM L ES S I NTEG R ATI O N From initial warranty through decades of operation, AES remains your single point of contact for all architectural cleanroom needs.
AES CLEANROOM TECHNOLOGY
| AES +Care Service Plan
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13
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AES +CARE SERVICE PLAN
Comprehensive cleanroom inspection Semi-annual inspections cover every critical architectural component of your cleanroom, delivered as a noninvasive visual assessment that can be performed during operations.
ARCHITECTURAL SYSTEMS INSPECTED
W H AT Y O U R E C E I V E
Walls & Panels
Comprehensive PDF Report
Dents, breaches, panel joints, cold welding, coved corners
After each site visit, with pass/fail criteria
Ceilings & Grid
Detailed Deficiency Log
Grid alignment, corrosion, tile seating, plenum seals, turnbuckles
Documenting any issues identified
Glazing & Windows
CAPA Plan
Glass integrity, mounting, fogging, seal quality
Corrective and preventative action, with timeline
Doors & Airlocks
Gaskets, sweeps, seals, interlock function, hardware
Prioritized Remediation Proposal
Floors & Coving
Cracks, delamination, coving adhesion, wall junction seals
Pass-Throughs
Seal integrity, operational function, access control
With 20% discount on AES-manufactured parts
Audit-Ready Documentation Supporting regulatory compliance
AES +CARE vs. GENERIC PROVIDERS Original Equipment Manufacturer
Access to Original Specifications
OEM Parts Discount
We built it
Full project history
Warranty Integration
CAPA Documentation
Lifecycle Support
Seamless from day one
Included with remediation plan
Design to service
20% off all AES parts
SERVICE SCOPE Semi-annual inspections (twice per year) Non-invasive visual assessment 3 business days typical Performed during operations with gowning accommodated
AES CLEANROOM TECHNOLOGY
Read the full
+Care Brochure in the AES digital library
| AES +Care Service Plan
VIEW BROCHURE
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OUR WORK
Proof, in production For four decades, AES has designed, manufactured, and built cleanroom facilities for the companies advancing medicine, from the largest global pharma to first-of-kind cell and gene therapy pioneers. A selection of that work follows.
Cell & Gene Therapy
Biologics & Biopharma
Iovance · Novartis (AveXis) · Spark · Kite · Beam Arcellx · Lyell · Astellas · Adaptimmune · Capsida
Amgen · Genentech · Gilead · Lonza · Merck Pfizer · BMS · Sanofi · Takeda · Regeneron
Aseptic & Fill-Finish
Academic & Institutional
Eli Lilly · Catalent · Patheon · INCOG · Ritedose Grifols · Baxter
University of Pennsylvania · CHOP · Duke · NIH MD Anderson · UPMC · WRAIR (US Army)
40
3,000+
7.5M+
17
100%
YEARS EXPERIENCE
PROJECTS DELIVERED
S Q . F T. CONSTRUCTED
F O YA H O N O R S
MADE IN THE U N I T E D S TAT E S
AES CLEANROOM TECHNOLOGY
| O u r Wo r k
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14
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OUR WORK
Featured, project profiles
FPO
FPO
Eli Lilly
Dendreon
CONCORD & DURHAM, NC · INDIANAPOLIS, IN · 100,000 SF
MORRIS PLAINS, NJ · UNION CITY, GA · SEAL BEACH, CA · 180,000 SF
Two identical NC campuses for injectable manufacturing, each 35,000 SF of cleanroom plus warehouse logistics. As Lilly's preferred cleanroom design-build contractor, AES delivered full TAKT planning from design through construction, building and commissioning each operating area independently in a staged fashion.
Infinity Glass Wall · Custom utility panels · Multi-site concurrent execution
Three 60,000 SF cellular immunotherapy cleanrooms for the maker of PROVENGE, the first FDA-approved cellular immunotherapy for prostate cancer. AES designed modular cleanrooms that could be duplicated across locations, with segregated workstations for cell therapy production and preplanned future expansion. Design-build methodology · Scalable / duplicable design Concurrent multi-site
2019 FOYA WINNER
2025 FOYA WINNER
FPO
FPO
Takeda
Amgen
CONCORD & DURHAM, NC · INDIANAPOLIS, IN · 100,000 SF
NEW ALBANY, OH · 100,000 SF PHASE 1
Plasma-derived therapies at one of the largest biotech sites in the world (1.1M+ SF). AES simultaneously executed work in four buildings under three CM firms, coming together seamlessly at completion. A single cleanroom supplier throughout gave the owner consistency and longterm aftermarket reliability.
A state-of-the-art assembly and packaging facility. AES was brought on early to meet aggressive schedule demands, leveraging the modular ceiling system for speed. Half-highwalls with full-vision panels and the Infinity wall bring an open concept with full visibility from the lobby into the facility.
4 buildings, 3 CM firms · Large natural-light viewing areas · Utility integration & speed
Modular ceiling speed · Infinity wall visibility · Concurrent 40,000 SF NC drug-substance
AES CLEANROOM TECHNOLOGY
| O u r Wo r k
16
14
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OUR WORK
Featured, project profiles continued
FPO
FPO
INCOG BioPharma
Iovance
FISHERS, IN · 20,000 SF
PHILADELPHIA, PA · 30,000 SF
A multi-phased aseptic formulation and final-filling facility for a leading CDMO. AES served as design-build partner with a custom cleanroom core and integrated HVAC, facilitating early procurement of long-lead items. Modular methods reduced project duration by 30% and cut onsite construction time by 25%.
The Iovance Cell Therapy Center, the first centralized, scalable manufacturing facility dedicated to TIL therapy for solid tumors. AES designed and built the modular cleanroom with efficient room design, walkable ceiling with integrated lighting, and full glass viewing sections with switchable-glass options.
30% faster overall · 25% less onsite time · Target-value designed
First-of-kind TIL facility · Switchable-glass viewing Expansion-ready
2023 ENR BEST PROJECT
FPO
FPO
Johnson & Johnson
VGXI
RARITAN, NJ · 20,000 SF · MULTI-PHASE
CONROE, TX · 20,000 SF
A three-phased CAR-T cell therapy expansion ongoing since 2020, now finalizing phase th to expand throughput and enable treatment of additional cancer patients. AES worked closely with IPS and HSC in early design-assist to meet the dynamic needs of J&J’s cell therapy business model.
A leading-edge CDMO producing high-quality plasmid DNA for vaccines and gene therapies. AES supported the project with modular architectural finishes, walkable ceilings, cleanroom walls, doors, light fixtures, HEPA filters, and accessories, built as phase 1 with room for expansion.
Early design-assist · Multi-phase expansion · CAR-T throughput
Plasmid DNA / vaccines · Phase 1 with expansion · Full modular finishes
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Philadelphia region spotlight A concentration of leading cell and gene therapy work in AES's home region, delivered with our union labor partner Plumbline for Philadelphia-based projects.
Spark Therapeutics
CCMT at CHOP
PHILADELPHIA, PA · 10,000 SF
PHILADELPHIA, PA · 9,000 SF
A decade of projects for Spark, from their original clinical manufacturing facility through expansions and now the new Gene Therapy Innovation Center with the Jacobs team, the first gene therapy manufacturing facility of its size in Philadelphia.
The Raymond G. Perelman Center for Cellular and Molecular Therapeutics: a Clinical Vector Core Suite with four viral vector suites, fill/finish, and cell expansion. FDA and EU compliant, with AES modular cleanroom, active pass-throughs, and large viewing windows.
More Philadelphia Region Projects University of Pennsylvania
Imvax
Adaptimmune
WuXi
Navy Yard (CRB / Jacobs)
UPMC Hillman
7,500 SF clinical manufacturing 3,000 SF, Curtis Building, Center City 20,000 SF and 5,000 SF, completed 2021
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3,000 SF, Curtis Building, Center City
10,000 SF cell therapy
5,000 SF clinical manufacturing
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More project profiles
FPO
FPO
Capsida Biotherapeutics
Astellas
NEWBURY PARK, CA · 10,000 SF
CAMBRIDGE, MA · 20,000 SF
A gene therapy facility for rare and more common diseases. AES delivered a fully turnkey facility, including air handling units, electrical, process integration, and architectural systems to meet cGMP compliance, built in under one year from design through completion, saving 30% in time versus traditional execution.
An allogeneic cell therapy facility focused on oncology, part of a larger build with lab, administration, and incubator areas. AES delivered a compliant, turnkey cleanroom, modular in design with walkable ceilings and perimeter-corridor vision bringing natural light into the facility.
Fully turnkey · Under one year · 30% time savings
Allogeneic oncology · Walkable ceilings · Natural-light vision
FPO
FPO
New Age Industries
Merck & Co.
SOUTHAMPTON, PA · 3,000 SF · ISO 7
WEST POINT, PA · BUILDING 63 · 20,000 SF
A single-use high-purity tubing leader that expanded during the pandemic. Using the AES design-build methodology with modular solutions (architectural system, mezzanine, lighting, HEPA, AHU, ductwork), AES cut overall project time 30% versus traditional methods and targetvalue-designed to budget.
One of dozens of AES projects for Merck spanning two decades across West Point, Virginia, New Jersey, Puerto Rico, and Sweden. AES delivered cleanroom scope with the modular architectural system and pre-engineered components for schedule and cost certainty.
30% faster · Full MEP + process scope · Target-value designed
20+ years with Merck · Multi-site relationship · Modular certainty
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Recent experience A snapshot of recent AES cleanroom projects across cell and gene therapy, biologics, fill-finish, and clinical manufacturing.
CLIENT
LO C AT I O N
YEAR
SCOPE
Amgen
Durham, NC
2023
50,000 SF cGMP manufacturing
Eli Lilly
Durham, NC
2022
31,000 SF aseptic processing, new campus
Novartis (AveXis)
Durham, NC
2020
35,000 SF cell & gene therapy
Novartis (Seqirus)
Holly Springs, NC
2020
20,000 SF fill-finish expansion
Astellas Gene Therapies
Sanford, NC
2021
15,000 SF gene therapy
Pfizer DCMF
Durham, NC
2021
25,000 SF gene therapy production
University of Pennsylvania
Philadelphia, PA
Ongoing
7,500 SF clinical manufacturing
NIH
Bethesda, MD
Ongoing
20,000 SF IV & clinical GMP (multiple)
MD Anderson
Houston, TX
Ongoing
5,000 SF clinical manufacturing
CHOA
Atlanta, GA
Ongoing
7,500 SF pharmacy & cell/gene suites
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Specialized experience Cell & Gene Therapy
Compounding Pharmacy
Design-build cleanroom experience across the leaders in advanced therapy:
AES-designed and built pharmacy projects nationwide:
Arcellx
Accredo / Express Scripts
Avid Bioservices
Children’s Hospital of Atlanta
Dendreon
Children’s National Medical Center
Genentech
Emory University Hospital
Lyell Immunopharma
Health First Cancer Institute
Theragent
NIH Pharmacy
Iovance
Penn Home Infusion
Novartis (AveXis)
Reading Hospital
Spark Therapeutics
UPMC (9 sites)
Kite Pharma
V.A. Medical Center
Beam Therapeutics
AtlantiCare Hospital
Adaptimmune
Tewksbury Hospital
Capsida Astellas Regenx Bio Houston Methodist
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References Selected professional references who can speak to AES’s delivery. Full contact details are available on request.
Jacobs
CRB
D E S I G N & P R O G R A M PA RT N E R
C O N ST R U C T I O N PA RT N E R
Multiple cell & gene therapy programs, including Spark Gene Therapy Innovation Center and Lilly parenteral
Navy Yard, Philadelphia ( 20,000 SF, completed 2021)
Johnson & Johnson
Beam Therapeutics
OW N E R
OW N E R
Raritan, NJ cell therapy, multi-phase design-assist
North Carolina precision genetic medicines facility
Spark Therapeutics
INCOG BioPharma
OW N E R
OW N E R
A decade of clinical manufacturing and gene therapy work
Fishers, IN aseptic formulation & filling CDMO
A E S CLIEN TS R ETU R N , P R OJ E CT AF TER P R OJ ECT The relationships above are representative, not exhaustive. From Eli Lilly and Merck to Spark and Beam, our reputation is proven through decades of repeat work with the companies advancing medicine.
AES CLEANROOM TECHNOLOGY
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Let's build it together. Bring us in early. The sooner AES is at the table, the more cost, schedule, and compliance risk we can take off your program before it ever reaches the field.
PHILADELPHIA HEADQUARTERS • Engineering • Project Management • Safety • Finance • Installation
IRVINE, CA OFFICE • Project Management • Project Development
AT L A N TA M A N U FAC T U R I N G
MANHEIM WAREHOUSE
• Fabrication Engineering • Manufacturing
• Phased Shipping • Future Manufacturing
• 80,000 square feet • 2 Lines
AES Cleanroom Technology, Inc. · A US-incorporated company since 1986, State of Pennsylvania
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