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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
Germfree is a leader in creating mobile and modular facilities specifically for cell and gene therapy (CGT) manufacturing. As CGT sits at the crossroads of medical research and pharmaceutical development, it demands highly specialized cleanroom designs. These designs must focus on efficient workflows, strict separation procedures, and rigorous aseptic processing to ensure the best results. Despite the quick growth and logistical challenges in the CGT field, Germfree’s mobile solutions effectively tackle these issues. They enable distributed manufacturing, ease the collection of patient cells, and help make CGT treatments accessible globally.
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 revolutionizes the biopharma industry by offering a cutting-edge, flexible solution for aseptic processing needs.
Key applications:
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Modular cGMP Cleanrooms for Gene Therapy Manufacturing
Unlock the full potential of your advanced therapy applications and pharmaceutical production processes with Germfree’s prefabricated Modular cGMP cleanroom facilities. Our facilities offer unparalleled flexibility, with a range of layout options and mechanical space configurations, whether you need a free-standing facility or one located in a shell building.
With our comprehensive services, including design, project management, supply chain, commissioning and qualification, and maintenance, we ensure a seamless experience from start to finish. Don’t settle for less than Germfree’s modular cleanroom facilities, the trusted solution 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 are a genuine, turnkey platform solution that enable both cGMP and cGMP/BSL-2 production.
Key applications:
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Innovative Aseptic Processing Equipment and PEC's
Germfree’s standard and custom equipment line was the foundation of our company over 60 years ago. We’ve been continuously innovating this equipment to create a cutting-edge line of primary engineering controls (PECs). Our PECs are 100% stainless steel, with delicate user ergonomics and the ability to handle both hazardous and non-hazardous materials. Plus, all of our equipment has a long service life spanning decades.
Check out our range of 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 Pass Throughs to see how we can meet your needs. Trust Germfree for top-quality equipment that’s built to last.
- 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
- Best-in-class for cleanability and durability
Talk to us about the right solution for your application
Contact usLooking for something custom?
We have deployed research facilities for shipment by military aircraft, designed equipment to contain the most dangerous agents on the planet, produced facilities to manufacture lifesaving medicines and mobilized hospital compounding during times of regulatory change. Connect with Germfree experts to unlock your scientific potential.
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