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Critical Solutions for Your Critical Environment

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Design Build

Owner’s Representation and Strategic Project Leadership

Projects are often exposed to unnecessary risk when planning, design, engineering, manufacturing, construction, and operational requirements are managed by separate groups with competing priorities. CleanSpace reduces that risk through a modern design build approach that aligns all stakeholders around shared objectives, operational requirements, budget expectations, schedule targets, and conditions of satisfaction from the very beginning.

As both a strategic advisor and integrated delivery partner, we help clients establish a clear path forward early in the project lifecycle. Our teams coordinate operational goals, compliance strategies, facility requirements, constructability, and long-term performance expectations into one unified execution plan, reducing gaps in communication, scope misalignment, costly redesigns, and downstream operational issues.

Because design, engineering, manufacturing, and construction are aligned under one accountable team, decisions are made with full visibility into project impact, operational performance, and lifecycle cost. This integrated approach improves coordination, accelerates decision making, and creates greater predictability across schedule, quality, compliance, and overall project delivery.

Capital and Operational Expenditures Efficiency

CleanSpace designs and engineers controlled environments with a focus on both capital efficiency and long-term operational performance. Our teams evaluate facility infrastructure, process requirements, maintainability, utility demand, workflow, and scalability early in the design phase to help clients make informed decisions that reduce unnecessary capital expenditures while improving operational reliability.

By integrating architecture, engineering, quality, and construction into one delivery model, we eliminate duplication, improve constructability, and streamline coordination between systems, trades, and operational requirements. This approach allows projects to move more efficiently from concept through completion while minimizing change orders, schedule delays, and operational disruption.

Operational efficiency is considered from the start, including environmental control strategies, maintenance accessibility, equipment integration, utility coordination, energy performance, future expansion capability, and long term facility adaptability. The result is a controlled environment designed not only to meet immediate compliance and production goals, but to support sustainable operational performance and reduced lifecycle costs over time.

Site Analysis and Conceptual Review

The success of any project begins well before design and construction. CleanSpace engages early to evaluate site conditions, infrastructure capabilities, operational workflows, regulatory requirements, and project feasibility to ensure the facility strategy aligns with both immediate objectives and long-term operational goals.

Our teams provide conceptual planning, business case planning, facility layout development, utility analysis, workflow coordination, preliminary budgeting, and constructability review to identify potential risks and opportunities before major investments are made. This early alignment helps clients make more informed strategic decisions while reducing uncertainty, avoiding downstream redesign, and improving overall project predictability.

Through a collaborative and technically driven planning process, CleanSpace establishes a strong operational and financial foundation that ensures compliance, scalability, schedule certainty, and successful commercialization.

Norwood, MA

PCT Sterile Filling and Operation

Square Footage

27,000

Special details

Phase 1 & 2 Expansion of vaccine plant.

Project Hightlights

  • Modular wall and ceiling panels, cleanroom doors, high-speed roll-up doors.
  • Filling line expansion, fast-track project.
Hatboro, PA

Process Systems

Square Footage

2,000

Special details

Medical tubing cleanroom suite.

Project Hightlights

  • ISO 7 Single-Use Product Assembly Room.
  • Gowning rooms, doors, interlocks.
  • Innovative Control Systems.
Emeryville, CA

Gene Therapy Pilot Plant

Square Footage

Not specified

Special details

New cGMP flexible clinical process suite for early clinical manufacturing.

Project Hightlights

  • Supports nuclease(s), mRNA-LNP, AAV, and Cell Therapy.
  • Three core gene therapy suites + two shared drug product filling operations.
  • Quality Control laboratories for bioassay, PCR, vector, and Microbiology.
Houston, TX

cGMP Manufacturing Facility

Square Footage

23,000

Special details

CleanSpace successfully delivered a 22,000 SF state-of-the-art facility, featuring 2,000 SF of office space, 10,000 SF of lab space, and 10,000 SF of cleanroom space. The project was originally managed by a large construction management (CM) firm before CleanSpace took over, implementing a more efficient design-build approach.

Project Hightlights

  • Transitioned from a design-bid-build model to a design-build strategy, aligning user quality requirements with budget constraints.
  • Achieved 25% cost reduction through value engineering, eliminating MEP system redundancies.
  • Delivered Certificate of Occupancy (CO) in just 11 months, outperforming the original CM firm's 16-month schedule.
  • The project included all design aspects, ensuring a seamless turnkey solution fully owned by CleanSpace.
College Station, TX; Bellingham, UK

Major CDMO Client

Square Footage

25,000

Special details

A global CDMO in pharmaceutical manufacturing providing process development and cGMP production in cell culture, microbial fermentation, and gene therapies.

Project Hightlights

Texas site will become the largest single-use CDMO campus in North America.