One Source For Life Sciences & Biotech Cleanroom Solutions
Life sciences programs don't move in a straight line. Today’s life sciences facilities must support rapidly evolving therapies, accelerated development timelines, and increasingly complex regulatory requirements. CleanSpace works with biotech, pharmaceutical, CDMO, CRO,and research organizations to design and build controlled environments that support every phase of development, from early discovery through cGMP manufacturing and commercial production. Our teams bring deep expertise in cleanroom design, aseptic processing, sterile compounding, advanced therapeutics, and regulated manufacturing environments supporting biologics, cell and gene therapy, AAV production, peptide compounding, and pharmaceutical operations.
We deliver scalable, high-performance environments engineered around process, compliance, workflow, and future growth. Whether supporting R&D laboratories, USP compliant compounding pharmacies, clinical manufacturing suites, or full-scale production facilities, our integrated design build approach aligns facility infrastructure with operational demands, FDA regulatory expectations, and evolving manufacturing technologies.Examination of CapEx and OpEx cost reductions and risk removal from the start.
Our certifications
Research & Development and Pharmaceutical Environments
Discovery and R&D Laboratories
Flexible laboratory environments supporting biotechnology research, analytical testing, process development, and controlled storage for sensitive materials and reagents.
Vivariums and Pre Clinical Research
Pharmaceutical Manufacturing
cGMP Environments Built for Biologics and Advanced Therapies
CleanSpace designs and builds controlled manufacturing environments engineered to support the evolving demands of cGMP regulated pharmaceutical and biotechnology operations. Our teams understand the critical relationship between process flow, equipment integration, environmental control, and regulatory compliance, allowing facilities to begin validated manufacturing from early clinical production through commercial scale operations.
Biologics Production
Controlled manufacturing environments supporting cell culture, fermentation, protein expression, monoclonal antibodies, recombinant therapeutics, and advanced therapy production.
Sterile and Aseptic Filling
ISO classified cleanroom environments engineered for aseptic processing, sterile liquid handling, fill finish operations, and closed system packaging workflows.
Vaccine and Injectable Production
Temperature controlled and cGMP compliant suites supporting biologics storage, sterile injectables, vaccine manufacturing, and fill finish operations.
CDMO and CRO Facilities
Flexible and scalable manufacturing environments designed to support multi program production, process development, and contract manufacturing operations.
Radiopharmaceutical and Compounding Environments
Radiopharmaceutical Production
Specialized controlled environments supporting radiopharmaceutical manufacturing, isotope handling, shielding integration, containment, and regulated production workflows.
Sterile Compounding Pharmacies
USP compliant cleanrooms supporting sterile compounding, aseptic preparation, hazardous drug handling, and pharmacy production operations.
503A and 503B Facilities
Controlled environments designed for outsourcing facilities and compounding operations requiring scalable cleanroom infrastructure, contamination control, and regulatory compliance.
Peptide and Specialty Compounding
Cleanroom environments supporting peptide compounding, specialty therapeutics, and evolving pharmaceutical preparation workflows requiring precision environmental control.
Biosafety Level Environments
BSL-1 through BSL-3 capable modular labs with specialized filtration, pressure control, and decontamination features
CQV, Compliance, and Operational Readiness
Bringing a regulated facility online requires far more than construction completion. Successful commercialization depends on a fully integrated approach to commissioning, qualification, validation, quality systems, operational readiness, and inspection preparedness. CleanSpace supports clients through every phase of the GMP lifecycle, helping align facility performance, process requirements, compliance strategy, and operational execution from startup through commercial readiness.
CleanSpace’s teams understand the critical relationship between facility infrastructure, aseptic operations, environmental control, process qualification, and long term cGMP compliance. From cleanroom certification and utility qualification to media fills, PPQ execution, and FDA inspection readiness, we help clients navigate the complex path from project turnover to stable manufacturing operations with greater confidence, reduced risk, and improved operational alignment.
Commissioning and Startup
Mechanical completion, utility startup, cleanroom certification, equipment commissioning, building automation verification, and baseline facility performance testing.
CQV and GMP Qualification
IQ and OQ execution for HVAC systems, cleanrooms, clean utilities, environmental monitoring systems, and process equipment supporting validated GMP operations.
Aseptic Qualification and Validation
Smoke studies, airflow visualization, environmental monitoring, operator qualification, media fills, cleaning validation, and contamination control strategy development.
Operational Readiness
Quality systems implementation, SOP development, training programs, supplier qualification, deviation management, and manufacturing readiness preparation. Examination of CapEx and OpEx from the start.
Process Performance Qualification
Engineering batches, PPQ execution, stability program initiation, batch record approval, and process validation activities supporting commercial manufacturing.
Inspection Readiness and Commercial Launch
Mock FDA audits, data integrity review, CAPA management, inspection readiness assessments, onboarding support, and commercialization planning for regulated manufacturing operations.
Why CleanSpace?
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
CleanSpace Insights
Improve the speed and efficiency, provoke dialogue for alignment and consider key decision points as you prepare for your next project.
