80+ deployments across the globe
80+ deployments across the globe
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EXPERT ENVIRONMENTS
EXPERT ENVIRONMENTS
Global Modular Cleanroom Solutions
Germfree since its inception in 1965 has been involved in delivering modular Cleanroom solutions to the Pharmaceutical and life sciences sectors. Our innovative approach in the delivery of these solutions has allowed us to stay ahead of the industries in delivering solutions that match the ever-evolving manufacturing approaches being adopted by our clients. Our modular approach to delivering our agile and multi model facilities has allowed us thru our bioGO® platform to deliver our solutions across the globe and to developing countries where the expertise may not be prevalent in the regions. Our Biopharma Equipment and bioGO® Mobile and Modular Cleanrooms are Offsite-built, Process- ready and available in standard and custom configurations. 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
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CASE STUDY Varlogic’s: MA
Design/fabrication & delivery thru qualification of a new modular cleanroom facility focused on development, manufacturing, testing, and F/F of Oncolytic Virus products in compliance with FDA & EU cGMP standards, in addition to BMBL/BSL-2 requirements. Scope requires use of a 2x 2,000L bioreactors in upstream processing suite, thus requiring an internal cleanroom height of 13+ ft (4.3m).
• 8 prefabricated modules • Unidirectional flow of P/M • Housed within shell structure
Location:
USA
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EXPERT ENVIRONMENTS
EXPERT ENVIRONMENTS
bioGO® Mobile by Germfree
Germfree’s bioGO® Mobile Cleanrooms are available in multiple configurations to meet a wide variety of cGMP product development, production, and training applications. Each facility is engineered and constructed to meet or exceed the current Good Manufacturing Practices, ISPE Baseline Guides®, and other relevant standards. Germfree has been manufacturing innovative, compliant facility and equipment solutions for nearly six decades.
Biopharma Applications: • Vector Production (Viral or Non-Viral) • Cell and Gene Therapy • mAbs • Recombinant Proteins • Cell Therapy (CAR-T, TIL) • Vaccine (up to BSL-3) • mRNA
Biopharma Clients • Innovator companies (Merck, Sanofi) • Contract Development Manufacturing Organizations (CDMOs) (Vibalogics, Resilience) • Research Institutions (NIH, Moffitt, Duke)
Healthcare • USP Compounding Pharmacy • BSL-2+ Clinical Laboratory • Cell Therapy (point of care delivery)
Temporary or Permanent Swing-Space
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CASE STUDY Large Pharma, Indianapolis, IN
Germfree was contracted to construct and fit out a 53’ mobile BSL-2 cGMP cleanroom facility to facilitate the production of investigational drug for a new antibody therapy for early mild to moderate COVID-19 illness.
Location:
USA
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EXPERT ENVIRONMENTS
USE AND 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).
CASE STUDY Mobile Hospital Compounding Pharmacy 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
Client:
Undisclosed
Completion: Project Type Application:
September 2019
Mobile
Pharmacy
Location:
USA
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EXPERT ENVIRONMENTS
USE AND APPLICATIONS Biopharma
On the cutting edge of modern science, viral vectors are enabling new cures and treatments that can be conducted within Germfree’s diverse line of laboratories and cleanrooms. This modern process involves using a virus as a vector to inject genetic material into the nucleus of a cell, thereby delivering necessary instructions to the host cell in question.
Aseptic Filling Cell & Gene Therapy mAbs Vaccines Viral Vectors
CASE STUDY Mobile Viral Vector Production Facility
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).
Client:
Undisclosed November 2016
Completion: Project Type Application:
Mobile
Biopharma
Location:
USA
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EXPERT ENVIRONMENTS
USE AND APPLICATIONS Biocontainment
Effective disease surveillance and response, biomedical research, and biosafety capabilities are critical to robust public health systems and overall global health security. Early detection and response initiatives promote the containment or control of an outbreak which may avert regional epidemics or a global pandemic. From our early years of Glove Box design and manufacture we have brought these learnings into our modular and mobile platforms. We build our facilities to meet the current global Bio Containment standards.
Applications
BioSafety and Biosecurity Biomedical and Infectious Disease Research Disease Surveillance and Response
CASE STUDY Animal Research Facility
Design/fabrication of a new BSL-3Ag animal research facility for working with risk group 3, highly pathogenic bacteria and virus. BSL- 3Ag suites include pressure decay tested suites with inflatable gasket doors. Setup for work with non-human primates, rodents with vivarium, histology and necropsy suites.
Client:
Undisclosed November 2019
Completion:
Area:
251 m2 Modular
Project Type Application:
Animal Health
Location:
USA
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EXPERT ENVIRONMENTS
USE AND APPLICATIONS Pharmacy
Drug compounding is the action of mixing, combining, or altering components to develop a medicine that meets the needs of a specific patient. If a patient is unable to be treated with an FDA-approved medication, compounded drugs may be utilized.
Applications
Hospital Compounding Pharmacies Radiopharmaceuticals 503a/503b Outsourcing Facilities
CASE STUDY HSE Germfree bioGO® Mobile cGMP Cleanroom The unit was design and commissioned to meet ISO 8 and comprises of the following:
ISO 8 Main Lab ISO 8 Preparation Room ISO 8 Ante Room CNC internal Lobby
Also an additional Pass Thru was integrated into the external fabric of the unit to allow for sperate Material flow to the wider facility.
Client:
HSE Ireland
Completion:
2022
Area:
40’ Modular Facility / 28m2
Project Type Application:
Modular
Pharmacy manufacturing Cork University Hospital
Location:
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bioGO® cGMP Trailer Suites
Standard Layouts
EXPERT ENVIRONMENTS
STANDARD LAYOUTS cGMP Bidirectional cGMP Bidirectional Standard Layouts
Designed for maximization of cGMP space for ATMP bioprocessing flows. Grade C background in bioprocessing suite and adjoining Grade D to C anteroom. Broad application base with integrated active pass-through for material handling. Ideal room layout for closed or semi-closed processes providing proper protection when working in a BSC. Designed for maximization of cGMP space for ATMP bioprocessing flows. Grade C background in bioprocessing suite and adjoining Grade D to C anteroom. Broad application base with integrated active pass-through for material handling. Ideal room layout for closed or semi-closed processes providing proper protection when working in a BSC. cGMP Bidirectional Designed for maximization of cGMP space for ATMP bioprocessing flows. Grade C background in bioprocessing suite and adjoining Grade D to C anteroom. Broad application base with integrated active pass-through for material handling. Ideal room layout for closed or semi-closed processes providing proper protection when working in a BSC.
cGMP Bidirectional with Grade B Room cGMP Bidirectional with Grade B Room Designed for complex manipulations required for some Cell and Gene Therapies and Regenerative Medicines process flows. Grade B background in bioprocessing suite and adjoining anteroom. Broad application base with integrated active pass-through for material handling. Ideal room layout for open or semi-closed processes providing ultimate protection when working in a BSC. cGMP Bidirectional with Grade B Room Designed for complex manipulations required for some Cell and Gene Therapies and Regenerative Medicines process flows. Grade B background in bioprocessing suite and adjoining anteroom. Broad application base with integrated active pass-through for material handling. Ideal room layout for open or semi-closed processes providing ultimate protection when working in a BSC. Designed for complex manipulations required for some Cell and Gene Therapies and Regenerative Medicines process flows. Grade B background in bioprocessing suite and adjoining anteroom. Broad application base with integrated active pass-through for material handling. Ideal room layout for open or semi-closed processes providing ultimate protection when working in a BSC.
cGMP Unidirectional cGMP Unidirectional
Designed for optimal space utilization and process flows for bioprocesses where a unidirectional flow is desired. Grade C background in bioprocessing suite and adjoining Grade D to C anteroom. Broad application base with integrated active pass-through for material handling. Ideal room layout for closed or semi-closed processes providing proper protection when working in a BSC. Designed for optimal space utilization and process flows for bioprocesses where a unidirectional flow is desired. Grade C background in bioprocessing suite and adjoining Grade D to C anteroom. Broad application base with integrated active pass-through for material handling. Ideal room layout for closed or semi-closed processes providing proper protection when working in a BSC.
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STANDARD LAYOUTS cGMP Unidirectional
Designed for optimal space utilization and process flows for bioprocesses where a unidirectional flow is desired. Grade C backgroundin bioprocessing suite and adjoining Grade D to C anteroom. Broad application base with integrated active pass- through for material handling. Ideal room layout for closed or semi-closed processes providing proper protection when working in a BSC. cGMP Unidirectional Designed for optimal space utilization and process flows for bioprocesses where a unidirectional flow is desired. Grade C background in bioprocessing suite and adjoining Grade D to C anteroom. Broad application base with integrated active pass-through for material handling. Ideal room layout for closed or semi-closed processes providing proper protection when working in a BSC.
bioGO® cGMP Trailer Suites
Germfree Laboratories, Inc +1 386-265-4300 | info@germfree.com Dual Facility cGMP w/ Large Grade B Bidirectional Multi-trailer design for optimal space utilization and process flows for bioprocesses where a bidirectional flow is desired. Large Grade B background in bioprocessing suite and adjoining anteroom. Broad application base with integrated active passthroughs for material handling. Ideal room layout for open or semi-closed processes providing proper protection when working in a BSC. germfree.com Standard Layouts (cont.) Dual Facility cGMP w/ Large Grade B Bidirectional Multi-trailer design for optimal space utilization and process flows for bioprocesses where a bidirectional flow is desired. Large Grade B background in bioprocessing suite and adjoining anteroom. Broad application base with integrated active pass- throughs for material handling. Ideal room layout for open or semi-closed processes providing proper protection when working in a BSC.
Dual Facility cGMP w/ Large Grade B Unidirectional Multi-trailer design for optimal space utilization and process flows for bioprocesses where a unidirectional flow is desired. Large Grade B background in bioprocessing suite and adjoining anteroom. Broad application base with integrated active pass- throughs for material handling. Ideal room layout for open or semi-closed processes providing proper protection when working in a BSC. 15
EXPERT ENVIRONMENTS
VIDEO WALKTHROUGH bioGO® Mobile cGMP Cleanroom Germfree’s business development director, George Walker walks through the bioGO® Mobile cGMP Cleanroom on the show floor at Advanced Therapies 2022.
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Your European & UK Team Get in touch directly At Ardmac your enquiry will be dealt with promptly by our highly experienced Team
Dermot McKenna Associate Director
George Walker Business Development Director 4 Scholar Green Road Cobra Court, Trafford Park Manchester M32 0TR UK george.walker@germfree.ie +44 (0) 161 8668086 www.ardmac.co.uk
Swords Business Campus Swords, Co. Dublin K67 D8H0 Ireland
dermot.mckenna@ardmac.com +353 (0) 1 894 8800 www.ardmac.com
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EXPERT ENVIRONMENTS
For US and International Inquiries: Germfree Laboratories, Inc. 4 Sunshine Blvd Ormond Beach, FL 32174 USA
+1 (386) 265-4360
Copyright © Germfree 2023
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