BIOPHARMA APPLICATIONS

Advanced Therapeutic Medicinal Products (ATMP)

ATMPs are emerging technologies at the intersection of biomedical research and drug discovery. ATMPs require unique facility design considerations for manufacturing.

Germfree’s expertise in producing cGMP modular and mobile cleanroom facilities and biocontainment laboratories provides unique expertise for addressing the challenges associated with manufacturing ATMPs.

Germfree’s bioGO cGMP mobile and modular cleanrooms are pre-designed and adaptive to provide an offsite built, process ready solution for advanced applications, available in 3 primary platform technologies:

· Mobile (portable mobile trailer/vehicle platform)
· Module (self-contained portable cleanroom module platform)
· Modular Cleanrooms (integrated, interconnected, multi-module, structural building platform)

Germfree’s prefabricated modular and mobile cleanrooms are manufactured in Germfree’s Ormond Beach facility and delivered onsite process ready.

Cleanroom Classifications: ISO 5, ISO 7, ISO 8, GRADE B, GRADE C, GRADE D, BSL-2, BSL-3, CGMP FDA, EMA compliant, BMBL compliant.

Germfree’s mobile and modular cleanrooms can be outfitted with Germfree’s advanced process and biosafety equipment which is purpose built to meet client user requirements, examples include: :

· Class II Biological Safety Cabinets
· Cleanroom Pass-throughs
· Laminar Flow Hoods
· Restricted Access Barrier Systems (RABS)
· Aseptic Isolators
· Dehumidification Chambers
· Cleanroom Tables, Shelves, and Workstations

Speak with an Expert today to learn more about how Germfree can amplify your process.

Past Germfree Projects

Germfree consistently delivers exceptional cGMP compliant products around the globe. Browse the grid below to see a selection of relevant past projects:

Mobile Hospital Compounding Pharmacy
Mobile
The remodeling of an I.V. pharmacy presents a range of potentially difficult or costly challenges. During building renovations it is imperative that compounding operations are not interrupted or otherwise negatively impacted
USA
Microbiome Research Modular Cleanroom
Biopharma Projects
This BSL 2+ cGMP Modular Biocontainment Cleanroom Facility is made up of five (5) prefabricated modules (2,000 ft2 / 184 m2 gross area) and is housed within a renovated warehouse structure. The cleanroom is designed to comply with FDA and EU cGMP standards and utilizes a unidirectional process flow.
Alachua, FL
Mobile Viral Vector Production Facility
Biopharma Projects
This Mobile BSL-3 Viral Vector Production Facility is based on quantity 2 semi-trailer chassis (840 ft2 / 79 m2 gross area) and functions as a mobile cGMP cleanroom to facilitate Viral Vector Manufacturing (VVM).
Maryland, USA

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It is the dedication of the Germfree team that enables rapid deployment of critical infrastructure both to cutting edge research facilities and the front lines of global health security