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Germfree designs and manufactures cGMP compliant cleanrooms and equipment for biopharma, from vaccine research and production to cell and gene therapy.
Industries
Biopharma Cleanrooms and Equipment
Biopharma Facilities and Equipment: Application Focused, Process-Ready
Germfree brings six decades of experience engineering critical environments for biopharma, where control, reliability, and execution cannot be afterthoughts. We construct our bioGO® mobile and modular cleanroom facilities and equipment offsite, ready for your process on delivery. We build QC and CQV in from the start.
Facilities and equipment meet accelerated timelines for cGMP development, production, and aseptic training, engineered and built to current US and EU Good Manufacturing Practices, ISPE Baseline Guides®, ISO 14644, and other applicable standards.
1000
+
Projects delivered globally
100
+
Mobile facility deployments
12
of the top 20 biopharma clients
cGMP Cleanrooms and Equipment
Platforms built for your process. Select from application ready layouts and equipment, or reach out to talk about a custom facility.
bioGO®: Mobile cGMP Cleanrooms for Biopharma Manufacturing
bioGO® is a cGMP Mobile Cleanroom trailer built for urgent biopharma manufacturing capacity needs, adaptable across a range of processes from cell therapy to sterile fill manufacturing. It’s built for clinical phase or point of care manufacturing, supported by design, fabrication, validation, and maintenance services.
Germfree designs and operates this mobile platform to meet FDA cGMP requirements and industry best practices, addressing the biopharma industry’s capacity challenges with a flexible, compliant manufacturing platform.
- Germfree has deployed more than 100 mobile cleanrooms globally since 2015
- Built for advanced therapy manufacturing, including cell and gene therapies
- cGMP compliance by design, ISO 7/8 Grade B, C and D
- Supported by 24/7 service, remote monitoring, and preventative maintenance
- Biosafety cabinets, laminar flow hoods, passthroughs, gowning benches, and 100% stainless steel casework
- FAT (commissioning), SAT (site commissioning), and qualification provided
- Available for sale or lease
Mobile cGMP Cleanrooms
Germfree’s Mobile cGMP Cleanroom platform supports aseptic processing needs with a flexible, rapidly deployable design.
Key applications:
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Modular cGMP Cleanrooms for Biopharma Manufacturing
Free-standing or built into a shell building, Germfree’s prefabricated Modular cGMP Cleanroom facilities flex to fit advanced therapy and pharmaceutical production processes, with layout options and mechanical space configurations built around your process, not the other way around.
Design, project management, supply chain, commissioning and qualification, maintenance: we manage your project end-to-end, and the result is a facility built for flexibility, reliability, and compliance in biopharmaceutical manufacturing.
- Onsite in approximately 8 months for standard platforms
- Compliant with US and EU cGMP, BSL2 and BSL3, ISPE Baseline Guides, and ISO 14644
- Supported by 24/7 service, remote monitoring, and preventative maintenance
- Can be combined with pharmaceutical isolators, RABs, biosafety cabinets, laminar flow hoods, passthroughs, gowning benches, and 100% stainless steel casework
- FAT (commissioning), SAT (site commissioning), and qualification provided
- Available for sale or lease
Modular cGMP Cleanrooms
Germfree cGMP Modular Cleanroom facilities support both cGMP and cGMP/BSL2 production.
Key applications:
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Aseptic Processing Equipment and Primary Engineering Controls
Germfree’s standard and custom equipment line has been the foundation of the company for over 60 years. Our primary engineering controls (PECs) are 100% stainless steel, engineered for precise user ergonomics, and built to handle both hazardous and non-hazardous materials. All equipment is built for a long service life spanning decades.
Pharmaceutical isolators and restrictive access barriers, laminar flow workstations, biological safety cabinets (BSCs), compounding aseptic isolators (CAIs), compounding aseptic containment isolators (CACIs), powder hoods, and material passthroughs are all built under one roof.
- Standard PECs ship fast
- NSF/ANSI49 options available
- Touch control interface available on some models
- 100% 304 and 316L stainless steel construction
- Modular facility integration
- Built for cleanability and durability
Pharmaceutical Isolators
Pharmaceutical Isolators
Smarthood™
Smarthood™
Stainless Steel Laboratory Furniture
Stainless Steel Laboratory Furniture
Engineered to Your Application
Biopharma runs on compliant processes and materials to develop drugs and therapies for patients. Process flow, flexibility, speed, manufacturing modality, and compliance are the challenges our customers face developing and manufacturing worldwide. Germfree facilities and equipment are built around those specific demands, not a standard offering.
Mobile and modular cleanrooms and equipment are built and tested to meet US and EU Good Manufacturing Practices, ISPE Baseline Guides®, ISO 14644, and other applicable standards for your application and region.
- A user requirements document and basis of design are developed with you to match your process requirements.
- Mobile and modular facility designs configure to your application and process requirements.
- Custom facilities and equipment take on your process, however complex.
- Ongoing QA/QC and FAT support faster onsite CQV and facility turnover.
- Modules are built in a controlled environment for consistent quality and adherence to industry standards.
- Facilities and equipment complete factory acceptance testing (FAT) before shipping, speeding up site acceptance testing (SAT) and commissioning and qualification.
Biopharma Applications We Serve
Antibody Drug Conjugates
Antibody Drug Conjugates
Vaccines
Vaccines
Plasmids
Plasmids
mAbs
mAbs
Gene Therapy
Gene Therapy
Viral Vectors
Viral Vectors
mRNA
mRNA
CRISPR
CRISPR
Cell Therapy
Cell Therapy
Aseptic Filling
Aseptic Filling
Frequently Asked Questions
What is a biopharma cleanroom?
Germfree manufactures both mobile (bioGO®) and modular biopharma cleanrooms offsite, ready for process on delivery. Each one meets current US and EU Good Manufacturing Practices, ISPE Baseline Guides®, and ISO 14644 standards.
What is the difference between Germfree’s mobile and modular cGMP cleanrooms?
Germfree’s mobile cGMP cleanroom (bioGO®) is a trailer-based platform — also known as a portable cGMP cleanroom trailer. It serves urgent capacity needs, clinical-phase manufacturing, and point-of-care production. We’ve deployed more than 100 units globally since 2015. Germfree’s modular cGMP cleanroom is a prefabricated facility that can stand alone or integrate into a shell building. It’s typically onsite in about 8 months, supporting cGMP and cGMP/BSL-2 production.
What compliance standards do Germfree’s biopharma facilities meet?
Germfree engineers its mobile and modular biopharma facilities and equipment to meet or exceed current US and EU Good Manufacturing Practices, ISPE Baseline Guides®, and ISO 14644 standards. We provide factory acceptance testing (FAT), site acceptance testing (SAT), and qualification with every one.
What applications do Germfree’s biopharma facilities and equipment support?
Germfree’s biopharma solutions support applications including antibody-drug conjugates, vaccines, plasmids, monoclonal antibodies (mAbs), gene therapy, viral vectors, mRNA, CRISPR, cell therapy, and aseptic filling.
What equipment is included with Germfree’s biopharma solutions?
Germfree’s biopharma equipment line includes pharmaceutical isolators, restrictive access barriers (RABs), laminar flow workstations, biological safety cabinets (BSCs), compounding aseptic isolators (CAIs), compounding aseptic containment isolators (CACIs), powder hoods, and material pass-throughs, plus 100% stainless steel casework. We build every one to last for decades.
When your mission calls for something custom, we deliver.
Some environments can’t take a catalog answer: the one-of-a-kind containment lab, the facility that has to survive shipment by military aircraft, the compounding pharmacy that has to stand up overnight. Tell us the constraints, we’ll build around them.
Related insights
360° Modular Facility Tour: Standard Single cGMP Compliant Module
360° Modular Facility Tour: Standard Single cGMP Compliant Module
Guidance for Cleanroom Pass Throughs in cGMP Cell and Gene Therapy Facilities
Guidance for Cleanroom Pass Throughs in cGMP Cell and Gene Therapy Facilities
Related resources
Germfree Biopharma Products Brochure
Germfree Biopharma Products Brochure
Germfree Modular cGMP Cleanroom Brochure
Germfree Modular cGMP Cleanroom Brochure
Germfree Mobile cGMP Cleanroom Product Brochure
Germfree Mobile cGMP Cleanroom Product Brochure
Germfree Class 2 Type A2 BSC Brochure
Germfree Class 2 Type A2 BSC Brochure
What You Can Count On
Proven Under Pressure
We take on the work that others won’t, and we see it through.
A Complete Capability
One team, accountable for the whole environment, design through service.
Beyond Delivery
Our relationships start before delivery and don’t end after it.
Built Around The Work
We shape the solution around your process, your site, and your use case, not the other way around.
Let's deliver on your mission together.
Tell us about your project and we’ll connect you with the right team within 24 hours.
Sales: + 1 (386) 265-4300
