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Critical Solutions for Your Critical Environment

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Industries

Pharmaceutical & Biotech

Pharmaceutical & Biotech

From Bench to Bedside

Clean, cold, and dry rooms for drug and biologic discovery and production

CleanSpace designs and installs controlled environments for manufacturers and CDMOs/CROs across all phases of pharmaceutical and biotechnology R&D and commercialization to ensure the safety, quality, and effectiveness of drugs and biologics. As the industry evolves, and use of robotics, intelligent controls, and automation increases, CleanSpace is committed to incorporating that innovation to its design process.

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Specific areas of focus include:

Academic Research
Pharmaceuticals
Biologics

Academic Research

  • Storage of sensitive reagents, proteins, enzymes, and antibodies

  • Clinical research

Pharmaceuticals

  • Clinical research, including laboratory experiments and clinical trials

  • Storage of active pharmaceutical ingredients and raw materials

  • Sterile manufacturing and packaging (drugs, vaccines, injectables)

Biologics

  • Cell culture and fermentation

  • Protein expression

  • Storage of temperature sensitive vaccines, monoclonal antibodies, and cell & gene therapies

  • Sterile and aseptic filling and handling

  • Storage of sensitive reagents, proteins, enzymes, and antibodies

  • ISO Class 5-level compliance

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CleanSpace worked with Metagenomi to master plan, design, and develop our cGMP clinical process suite. They were an exemplary partner from start to finish, displaying a high level of professionalism, thoughtfulness, and flexibility.

Jian Irish
President & COO of Metagenomi

The CleanFit Process

CleanFit accelerates the design to installation process and is what enables CleanSpace to offer timeline and budget guarantees.

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.

Houston, TX

Packgene Biotech – 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.
Confidential Client, Emeryville, CA

Gene Therapy Pilot Plant, Confidential Client

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.
Hatboro, PA

Sentinel 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.
Norwood, MA

Moderna

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.