BIOPHARMA APPLICATIONS

Cell & Gene Therapy

Cell therapy and gene therapy are intersecting fields of biomedical research and cure discovery. Both therapies focus on the prevention, treatment, and cure of diseases and have the potential to alleviate the underlying cause of both genetic and acquired diseases. Cell therapy treats diseases by modifying certain sets of cells or by using cells to deliver a therapy within the body. In cell therapy, cells are cultivated or modified outside the body before being injected into the patient. The cells may originate from the patient (autologous cells) or donor(s) (allogeneic cells).

Gene therapy treats diseases by inactivating, introducing, or replacing genes within cells. There are two methods for manufacturing and delivery of gene therapies – in vivo (inside the body) and ex vivo (outside of the body).

Some therapies are considered both cell and gene therapies. These therapies treat diseases by altering genes (ex vivo) in specific cell types and delivering them into the body.

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

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

Germfree’s advanced process and biosafety equipment is purpose built to meet client user requirements and includes:

· 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