Application

CRISPR

Delivering CRISPR-Cas9 therapy with lipid nanoparticles or viral vector manufacturing technology

Revolutionizing gene editing: Germfree's pioneering cleanroom solutions propel CRISPR manufacturing forward

CRISPR manufacturing runs on precision. Because of this, particulate contamination control and workflow discipline aren’t nice-to-haves, they’re what keeps product safety and quality intact. Germfree designs cleanroom solutions built specifically for CRISPR-based technologies and their delivery systems, with facility layouts sized and configured to the application in front of us.

Facilities and Equipment for CRISPR Manufacturing Using Lipid Nanoparticle and Viral Vector Delivery Systems

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 cGMP Cleanrooms for CRISPR Manufacturing

Capacity constraints in CRISPR manufacturing rarely wait for a facility buildout to catch up. bioGO® is Germfree’s cGMP mobile cleanroom trailer, built to bring aseptic manufacturing capacity onsite fast, whether the work is cell therapy or sterile fill. It suits clinical-phase production and point-of-care manufacturing alike, and every unit is backed by Germfree’s full service stack: design, fabrication, validation, and ongoing maintenance. Germfree engineers and operates each mobile platform to meet and exceed FDA cGMP requirements and current industry practice, giving manufacturers a compliant, flexible way to scale capacity without the delay of new construction.

Learn more about our mobile facilities

Germfree has deployed more than 100 cGMP and USP <797> and <800> mobile cleanrooms globally since 2015
Ideal for advanced therapy manufacturing, including lipid nanoparticle and viral vector manufacturing
Enhanced particulate control and cGMP compliance by design, ISO 7/8 Grade B, C and D
Integrated Biosafety Cabinets, Laminar Flow Hoods, Pass-throughs, Gowning Benches and 100% Stainless Steel Casework
Rapid deployment for expedited clinical development
Available for sale or lease to maximize 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 CRISPR 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 expedited manufacturing capability and capacity using Germfree’s standard application platforms
Compliant: US & EU cGMP – BSL2 -BSL3, ISO 14644
Enhanced particulate control and cGMP by design
Optimized work flows to reduce manufacturing risk
Can be integrated with Pharmaceutical Isolators, RABS, Biosafety Cabinets, Laminar Flow Hoods, Pass-throughs, Gowning Benches and 100% Stainless Steel Casework
FAT (commissioning), SAT (site commissioning) and qualification provided
Available for sale or lease to optimize capital spend

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 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.

Learn more about our equipment

Enhanced equipment integration with Restricted Access Barrier Systems (RABS), Pharmaceutical Isolators, Biosafety Cabinets, and Laminar Flow Hoods
NSF/ANSI49 options available
Innovative touch control interface on some models
100% 304 and 316 L Stainless Steel Construction
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 requirements apply to CRISPR manufacturing?

CRISPR manufacturing requires strict adherence to particulate contamination control and operational workflows, ensuring safety and product quality for this transformative field.

Does Germfree support lipid nanoparticle and viral vector delivery systems?

Yes. Germfree’s cleanroom solutions support the effective production of CRISPR-based technologies and their delivery systems, including lipid nanoparticle and viral vector manufacturing.

What mobile cleanroom options are available for CRISPR manufacturing?

The bioGO® cGMP Mobile Cleanroom trailer supports advanced therapy manufacturing, including lipid nanoparticle and viral vector manufacturing, with enhanced particulate control and cGMP compliance by design (ISO 7/8 Grade B, C and D).

Are modular cleanrooms available for CRISPR manufacturing?

Yes. Germfree’s prefabricated Modular cGMP Cleanroom facilities support advanced therapy and pharmaceutical production processes, available as free-standing facilities or located in a shell building, with onsite delivery in approximately 8 months for standard application platforms.

What equipment can be integrated with Germfree’s CRISPR manufacturing facilities?

Facilities can be integrated with pharmaceutical isolators, Restricted Access Barrier Systems (RABS), biosafety cabinets, laminar flow hoods, pass-throughs, gowning benches, and 100% stainless steel casework.

Can Germfree’s cleanroom facilities support both cGMP and BSL-2 production for CRISPR manufacturing?

Yes. Germfree cGMP Modular Cleanroom facilities are a turnkey platform solution that enable both cGMP and cGMP/BSL-2 production.

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.

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