Modular Cleanroom Solutions for the Life Sciences Revolution
From Bench to Bedside: Accelerating Biotech and Pharma R&D
Life sciences programs don't move in a straight line. A biotech startup can pivot from oncology to gene therapy in a single funding cycle. A CDMO can go from early-phase clinical production to commercial manufacturing within years. CleanSpace designs modular environments that support every stage of that journey, and because the walls are reconfigurable, your facility evolves as fast as your science does.
Discovery
Academic and R&D wet labs; storage of sensitive reagents, proteins, enzymes, and antibodies
Pre-Clinical
Clinical
Commercial
cGMP Compliant Manufacturing for Drugs and Biologics
CleanSpace delivers modular and prefabricated cleanroom systems engineered to meet the strict requirements of cGMP and GMP regulated facilities worldwide. Our in-house, US-manufactured systems meet UL, FM, and ASTM standards and are designed to achieve the ISO classified cleanroom performance levels required for pharmaceutical, biotechnology, and other FDA-regulated manufacturing environments. Our team understands the relationship between process architecture, equipment requirements, and environmental control, ensuring facilities are designed to support validated manufacturing operations from day one.
Pharmaceutical Manufacturing
Clinical research, API storage, sterile drug manufacturing, vaccines, and injectables
Biologics Production
Cell culture and fermentation, protein expression, monoclonal antibodies, and cell and gene therapies
Sterile and Aseptic Filling
Controlled environments for sterile liquid handling, aseptic filling, and closed-system packaging
CDMO and CRO Facilities
Flexible, validated environments for contract manufacturers serving multiple clients and programs
Vaccine and Injectable Production
Temperature-controlled, ISO-compliant suites for biologics storage and fill-finish operations
Academic and R&D Laboratories
Configurable wet lab environments for discovery-stage research and reagent storage
Advanced Containment for Animal Health and Veterinary Research
The convergence of human and animal health research, often called "One Health," requires the same level of sterility, containment, and precision as human pharmaceutical manufacturing. CleanSpace designs vivarium environments, veterinary research suites, and animal health production facilities that meet the same rigorous standards as their human pharma counterparts. Whether you are developing veterinary biologics or conducting pre-clinical safety studies, your research environment needs to perform without compromise.
Vivarium Research Suites
HEPA-filtered, pressure-controlled environments for animal housing in regulated research settings
Veterinary Biologics Manufacturing
cGMP environments for veterinary vaccine and biologic production
Pre-Clinical Study Facilities
Controlled spaces for animal model research supporting IND applications and regulatory submissions
Biosafety Level Environments
BSL-1 through BSL-3 capable modular labs with specialized filtration, pressure control, and decontamination features
The CleanFit Validation Advantage
Validation is one of the most time-consuming and costly phases of any life sciences facility project. The IQ/OQ process for a traditionally built room can stretch timelines by months because documentation has to be assembled retroactively from field work. CleanSpace's modular construction approach simplifies this significantly. Because systems are engineered and manufactured in a controlled factory environment, documentation is generated as part of the build, not reconstructed after the fact. Your validation team starts from a stronger foundation and gets to operational readiness faster.
Specific areas of focus include:
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
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.
Life Sciences Projects We've Delivered
Major CDMO Client
Packgene Biotech – cGMP Manufacturing Facility
Gene Therapy Pilot Plant, Confidential Client
Sentinel Process Systems
Moderna
The CleanFit Process
CleanFit accelerates the design to installation process and is what enables CleanSpace to offer timeline and budget guarantees.
CleanSpace Insights
Improve the speed and efficiency, provoke dialogue for alignment and consider key decision points as you prepare for your next project.
