Architecture and Engineering for Controlled Environments

This 16,350 SF compounding pharmacy was developed to support the production of specialized pet medications for a Confidential Client. The facility includes compounding suites, laboratory support spaces, office areas, a warehouse, and a dedicated mechanical equipment platform. The project required a highly coordinated approach to integrate cleanroom systems within an existing building footprint.

• Modular cleanroom solution tailored to an existing building with structural limitations
• ISO 8 environments designed for pharmaceutical compounding operations
• Walkable ceiling supported by the Apex Trellis System for enhanced access and maintenance

This project expands an existing pharmaceutical manufacturing facility in Toronto, Ontario, to increase production capacity and introduce new sterile and nonsterile processing capabilities. The scope includes a two-story addition with sterile manufacturing suites, supporting infrastructure, and expansion of the existing Purified Water System.

The addition integrates with an active, space-constrained facility. Major HVAC, mechanical, electrical, and utility infrastructure is located on the second floor to maximize production space, with planning focused on system coordination, installation sequencing, and continuity of existing operations.

• Sterile manufacturing environments: New manufacturing suites with coordinated cleanroom systems and supporting process infrastructure.
• Two-story addition: Second-floor infrastructure preserves production space and supports equipment and utility requirements.
• Critical utility expansion: Expansion of the existing Purified Water System and integration of new process utilities.
• Active facility integration: Coordination of new and existing building systems within a constrained operating environment.
• Complex installation interfaces: Alignment of cleanroom assemblies, mechanical and electrical systems, equipment support, and penetrations.
• Future capacity planning: Infrastructure designed to accommodate evolving production needs and future growth.

CleanSpace delivered a 22,000 SF turnkey design-build cGMP biopharmaceutical manufacturing facility in Houston, Texas, supporting gene therapy production. The facility includes 10,000 SF of cleanroom space, 10,000 SF of laboratory space, and 2,000 SF of office space, with Grade A, B, and C controlled environments supporting concurrent processing of multiple gene therapies.

After transitioning the project from a design-bid-build model to an integrated design-build strategy, CleanSpace streamlined design and execution through value engineering, MEP optimization, and coordinated project delivery. The project achieved a 25% cost reduction and Certificate of Occupancy in 11 months, compared with the original 16-month schedule.

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• Designed for concurrent processing of multiple gene therapies
• Regulatory objectives addressing FDA, EMA, Japan, and MHRA requirements
• Full in-house manufacturing capability including process and analytical development labs and quality control labs
• Flexible manufacturing configuration supporting evolving production needs
• Planned expansion capability into adjacent space
• Execution maintained within an active, mission-critical environment

CleanSpace provided design-assist and preconstruction services for a major CDMO manufacturing campus in College Station, Texas, supporting cell culture, microbial fermentation, and gene therapy production. CleanSpace worked collaboratively through the transition from design into construction, helping align controlled environment solutions with the requirements of a large-scale cGMP manufacturing program.

The approach incorporated the client’s global facility standards, with an emphasis on standardization, innovation, and modularization to support consistency across its worldwide manufacturing network.

• Design-assist and preconstruction services
• Large-scale cGMP biopharmaceutical manufacturing campus
• Cell culture, microbial fermentation, and gene therapy applications
• Design coordination through transition into construction
• Alignment with established global facility standards
• Focus on repeatable, standardized controlled environment solutions
• Modularization incorporated into project planning and design

CleanSpace developed a 1,000 SF cGMP clinical manufacturing suite within an existing facility in Emeryville, California, supporting early-stage manufacturing of novel therapeutic technologies. The facility was designed to accommodate nuclease-based processes, mRNA-LNP, AAV, and cell therapy, providing a flexible controlled environment for multiple emerging modalities.

The modular cleanroom incorporates three gene therapy suites with shared filling capabilities, along with airlocks, preparation areas, locker rooms, cold storage, and dedicated QC laboratory functions. CleanSpace’s scope included aluminum honeycomb-core wall systems, grid ceilings, plenum systems, integrated windows, doors, coving, and associated cleanroom components.

• Three gene therapy suites with two shared filling units
• Manufacturing support areas including airlocks, prep space, locker rooms, and cold storage
• Dedicated QC areas supporting bioassay, PCR, vector, and microbiology
• Modular aluminum honeycomb-core wall system
• Integrated ceiling, plenum, door, window, coving, and trim systems
• Multiple therapeutic modalities accommodated within a compact clinical manufacturing footprint

CleanSpace delivered a 10,000 SF cleanroom box within a 13,000 SF renovation in Pennington, New Jersey, converting existing space to support cell and gene therapy manufacturing. The project required the new controlled environment to fit within the building’s existing structure while accommodating the equipment, utilities, and movement of people and materials needed for manufacturing operations.

Most of the cleanroom was constructed with 9-foot ceilings, while one area reaches 12 feet to meet specific operational needs. CleanSpace also provided a custom crash rail protection system and a tube pass-through, integrating these features into the cleanroom layout. Careful coordination of the cleanroom components, building conditions, and installation sequence helped bring the new space together within the facility’s available footprint.

The completed cleanroom gives the client a controlled manufacturing environment designed for its current operations and planned future commercial production.

• 10,000 SF cleanroom box within a 13,000 SF renovation
• Conversion of existing space for GMP manufacturing
• 9-foot ceilings with a 12-foot-high area for operational needs
• Custom crash rail protection and tube pass-through
• Cleanroom installation coordinated with existing building conditions

CleanSpace supported the delivery of a new biomanufacturing facility in Hopewell, New Jersey, providing cleanroom environments for the client’s first U.S. manufacturing site. The project brought controlled environment requirements together with the facility’s production equipment and building systems to support biologics manufacturing.

• Cleanroom environments designed for advanced biologics production
• Coordination with manufacturing equipment and supporting building systems
• Facility designed to accommodate both fed-batch production and a modular continuous manufacturing platform

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CleanSpace delivered a 5,700 SF ISO 7 cleanroom in Charlotte, NC. The turnkey scope included cleanroom construction and coordination of the mechanical, electrical, and plumbing (MEP) systems from design through installation. The team integrated prefabricated components with work performed on site, managing installation sequencing and system interfaces to meet the project’s schedule, quality, and performance requirements. Systems were tested and commissioned to support operational readiness and client handoff.

• Delivered a 5,700 SF ISO 7 cleanroom through a turnkey scope.
• Coordinated MEP systems from design through installation.
• Integrated prefabricated components with on-site construction and MEP work.
• Tested and commissioned systems to support operational readiness.

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Phase 1 & 2 Expansion of vaccine plant.

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

Medical tubing cleanroom suite.

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

New cGMP flexible clinical process suite for early clinical manufacturing.

• 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.

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.

• 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.

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

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