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Monoclonal Antibodies (mAbs)
Harnessing biotechnology to deliver targeted and effective therapies
Navigating the technical challenges of mAbs production and scalability
Monoclonal antibodies (mAbs) offer promising immunotherapy treatments, targeting antigens and diseases. Manufacturing these complex therapies presents challenges in scaling up, cost, and consistency. Germfree’s expertise in tailored cleanroom solutions addresses these obstacles, ensuring sterility and seamless equipment integration. By providing advanced facilities for both small-scale clinical trials and larger-scale production, Germfree contributes to the successful development and commercialization of mAbs, ultimately improving patient outcomes and transforming healthcare landscapes.
Cleanrooms and Equipment for mAbs Production
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 mAbs 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 and USP <797>/<800> mobile cleanrooms globally since 2015
- Integrated biosafety cabinets, laminar flow hoods, pass-throughs, gowning benches and 100% stainless steel casework
- Enhanced particulate control and cGMP compliance by design, ISO 7/8 Grade B, C and D
- Supported by comprehensive services, including 24 hour/ 7 day a week 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 maximize capital spend
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 mAbs Manufacturing
Unlock the full potential of your advanced therapy applications and pharmaceutical production processes with Germfree’s prefabricated modular 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, 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
- Can be combined with Pharmaceutical Isolators, RABs, Biosafety Cabinets, Laminar Flow Hoods, Passthroughs, 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 equipment ships fast
- NSF/ANSI49 Options Available
- Innovative touch control interface on some models
- 100% 304 and 316 L Stainless Steel Construction
- Modular or mobile facility integration
- Best-in-class for cleanability and durability
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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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