AES_Qualifications_Package

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

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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

6

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

7

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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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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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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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.

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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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