Application

Cell & Gene Therapy Cleanrooms

From bench to bedside: The journey of cell therapy manufacturing

Delivering on the promise of cell and gene therapy through Germfree products and services

Germfree Laboratories offers advanced modular and mobile facilities, equipment, and comprehensive services for cell therapy manufacturing. Acknowledging the complexity of personalized treatments, Germfree’s adaptable solutions optimize production processes, ensuring aseptic conditions, scalability, and compliance with regulatory standards. This enables efficient, high-quality cell therapy delivery to patients in need, supporting manufacturers in overcoming industry challenges.

Fit-for-purpose Facilities and Equipment for Cell 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.

Mobile

bioGO^®: Mobile Cell & Gene Therapy Cleanrooms

The bioGO® cGMP Mobile Cleanroom trailer meets urgent biopharma manufacturing capacity needs, adaptable across processes from cell therapy to sterile fill manufacturing, and built for clinical phase or point-of-care work. It’s backed by full-service support: design, fabrication, validation, and maintenance.

Germfree engineers and operates the platform to meet and exceed FDA cGMP requirements and industry best practice, giving biopharma manufacturers a flexible, compliant way to add cell therapy manufacturing capacity.

Learn more about our mobile facilities

Germfree has deployed more than 100 cGMP and USP <797> and <800> mobile cleanrooms globally since 2015
Built on a standard platform; configurable to meet application requirements ISO 7/8 Grade B, C and D
Designed for distributed and point-of-care manufacturing with ability to network mobile manufacturing sites
Rapid deployment in weeks not months; gain access to the clinic sooner
Available for sale or lease to optimize your capital spend

Mobile cGMP Cleanrooms

Germfree’s Mobile cGMP Cleanroom platform supports aseptic processing needs with a flexible, rapidly deployable design.

Key applications:

Cell Therapy

Gene Therapy

Aseptic Filling

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Modular

Modular cGMP Cleanrooms for Cell 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.

Learn more about our modular facilities

Onsite in ~ 8 Months for standard platforms
Compliant: US & EU cGMP, BSL2, 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, 24 hour/ 7 day a week service support, remote monitoring and preventative maintenance
Available for sale or lease
Relocatable when manufacturing needs change

Modular cGMP Cleanrooms

Germfree cGMP Modular Cleanroom facilities support both cGMP and cGMP/BSL2 production.

Key applications:

Aseptic Filling

CGT Manufacturing

Viral Vectors

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Equipment

Innovative Aseptic Processing Equipment and PECs

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 line of primary engineering controls (PECs), refined over six decades. Our PECs are 100% stainless steel, with intuitive ergonomic design 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.

Learn more about our equipment

Standard Biosafety Cabinets and Laminar Flow Hoods ships fast
NSF/ANSI49 Options Available
Innovative touch control interface on some models
100% 304 and 316 L Stainless Steel Construction
Modular or mobile cleanroom facility integration
Durable and easy to clean, backed by a service life spanning decades

All EQT- Biopharmaceutical Isolators & RABS EQT-Class II Type A2 BSC EQT-Class II Type B2 BSC EQT-Vertical Laminar Airflow Workstation EQT-Horizontal Laminar Airflow Workstation EQT - 100% Stainless Steel Casework EQT-Pass-Through

Pharmaceutical Isolators

Germfree designs and manufactures cGMP-compliant pharmaceutical isolators in the USA, protecting products, personnel, and laboratory processes.

Smarthood™

Smarthood™ is our innovative solution that integrates essential peripherals like touchscreen PCs, cameras, scales, and printers directly into a clean, clutter-free hood, enhancing aseptic technique and streamlining your workflow.

Stainless Steel Laboratory Furniture

Germfree's 100% stainless steel laboratory furniture resists corrosion, rust, and bacterial growth, custom designed for your lab or cleanroom.

Frequently Asked Questions

Explore additional insights

What cleanroom options does Germfree offer for cell and gene therapy manufacturing?

Two platforms: the bioGO® mobile cGMP cleanroom trailer for urgent capacity needs and clinical-phase or point-of-care manufacturing, and modular cGMP cleanroom facilities for standalone or shell-building installations supporting advanced therapy and pharmaceutical production.

How quickly can a mobile cGMP cleanroom be deployed for cell and gene therapy work?

Germfree has deployed more than 100 cGMP and USP <797>/<800> mobile cleanrooms globally since 2015, with rapid deployment in weeks, not months.

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 a free-standing installation and integration into a shell building, and are compliant with US & EU cGMP, BSL2, ISPE Baseline Guides, and ISO14644.

What equipment does Germfree offer alongside its cleanroom platforms?

A line of primary engineering controls (PECs), including pharmaceutical isolators, laminar flow workstations, biosafety cabinets, compounding aseptic isolators and containment isolators, powder hoods, and material pass-throughs, all 100% stainless steel construction.

Talk to us about the right solution for your application

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.

Get started on yours