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Gene Therapy
Manufacturing gene therapy products: Navigating complexity to deliver groundbreaking, lifesaving treatments
Delivering on the promise of cell and gene therapy
Gene and cell therapy manufacturing lives at the intersection of medical research and pharmaceutical production, which means cleanroom design has to satisfy both worlds at once. Efficient workflows, strict separation between processes, and rigorous aseptic technique aren’t optional extras here, they’re the baseline. As the CGT field scales, manufacturers run into a familiar bottleneck: fixed construction can’t keep pace with demand. Mobile and modular facilities close that gap. They put distributed manufacturing within reach, make patient cell collection easier logistically, and put CGT treatments within reach of more patients worldwide.
Fit-for-purpose Facilities and Equipment for Gene Therapy Manufacturing
Select from a number of application-ready layouts & equipment. If these do not meet your needs, reach out and learn more about our custom solutions.
bioGO®: Mobile cGMP Cleanrooms for Gene Therapy Manufacturing
Discover bioGO® cGMP Mobile Cleanroom trailer, designed to address urgent biopharma manufacturing capacity needs with versatility and adaptability to a range of processes, from cell therapy to sterile fill manufacturing. Perfect for clinical phase or point-of-care manufacturing, and supported by comprehensive services, including design, fabrication, validation, and maintenance.
Germfree’s expertise drives the design and operation of this mobile platform, meeting and exceeding FDA cGMP requirements and industry best practices. Choose bioGO® for flexible, reliable, and compliant manufacturing solutions to address the biopharma industry’s capacity challenges.
- Germfree has deployed more than 100 cGMP, USP <797> and <800> mobile cleanrooms globally since 2015
- cGMP compliance by design, ISO 7/8 Grade B, C and D
- Biocontainment level BSL-2+
- Supported by comprehensive services, commissioning and qualification, including 24/7 service support, remote monitoring, and preventative maintenance
- Rapid deployment in weeks not months; gain access to the clinic sooner
- Available for sale or lease to optimize capital utilization
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 Gene Therapy Manufacturing
Germfree’s prefabricated Modular cGMP Cleanroom facilities support advanced therapy and pharmaceutical production processes, with layout options and mechanical space configurations for a free-standing facility or one inside a shell building. Design, project management, supply chain, commissioning and qualification, and maintenance are handled as one service, start to finish. Germfree’s modular cleanroom facilities are built for flexibility, reliability, and compliance in biopharmaceutical manufacturing.
- Onsite in ~ 8 Months for standard platforms
- Compliant: US & EU cGMP – BSL2 -BSL3 – ISPE Baselines Guides, ISO14644
- Flexible layout configurations based on standard platform technology
- High-quality construction by design minimizes risk of contamination
- Provided turnkey with comprehensive services, including commissioning and qualification and 24/7 service support, remote monitoring, and preventative maintenance
- Can be combined with Pharmaceutical Isolators, RABS, Biosafety Cabinets, Laminar Flow Hoods, Pass-throughs, Gowning Benches and 100% Stainless Steel Casework
- 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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Innovative Aseptic Processing Equipment and PECs
Germfree built its first piece of equipment more than 60 years ago, and every primary engineering control in our current line carries six decades of refinement forward: 100% stainless steel construction, ergonomic design built around the people who use it, and the ability to handle both hazardous and non-hazardous materials. That track record is what a service life measured in decades looks like in practice. Our range covers Pharmaceutical Isolators and Restricted Access Barrier Systems, Laminar Flow Workstations, Biological Safety Cabinets (BSCs), Compounding Aseptic Isolators (CAIs), Compounding Aseptic Containment Isolators (CACIs), Powder Hoods, and Material Pass Throughs. Six decades in, we know what holds up.
- Standard Biosafety Cabinets and Laminar Flow Hoods ship fast
- NSF/ANSI49 options available
- Innovative touch control interface on some models
- 100% 304 and 316 L stainless steel construction
- Mobile and modular facility integration
- Durable and easy to clean, backed by a service life spanning decades
Pharmaceutical Isolators
Smarthood™
Stainless Steel Laboratory Furniture
Frequently Asked Questions
What kind of cleanroom facility is needed for gene therapy manufacturing?
Gene therapy manufacturing demands specialized cleanroom designs with efficient workflows, strict separation procedures, and rigorous aseptic processing at every stage, available through both mobile and modular Germfree platforms.
What is bioGO®?
Germfree built bioGO® as a cGMP mobile cleanroom trailer for urgent biopharma manufacturing capacity needs across a range of processes, from cell therapy to sterile fill manufacturing, and suited to clinical phase or point-of-care manufacturing.
Can a modular cGMP cleanroom be integrated into an existing building, or does it need to be freestanding?
Either. Germfree’s modular cGMP cleanroom facilities support both freestanding installation and integration into a shell building.
What equipment can be combined with a modular cGMP cleanroom for gene therapy applications?
Pharmaceutical isolators, RABS, biosafety cabinets, laminar flow hoods, pass-throughs, gowning benches, and 100% stainless steel casework.
How do I get started on a gene therapy facility project?
Tell us about your project and we’ll connect you with the right team within 24 hours, or call Sales at +1 (386) 265-4300.
Talk to us about the right solution for your application
Contact usWhen 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
Beyond the Blueprint: Practical Infrastructure for Cell Therapy Manufacturing
Advancing Patient Access Through Decentralized Manufacturing
Related resources
Germfree Biopharma Products Brochure
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
