GERMFREE
CASE STUDIES

Modular Cell and Gene Therapy ISO 7 Cleanroom Facility

Project Title:ISO 7 – CG & T
Client:A National Public Health Organization
Project Type:Modular
Application:Biopharma
Location:Maryland, USA

project

Project Information:

Germfree was tasked to design and build a bioGO® Modular Cell/Gene Therapy Facility to serve a National Public Health Organization for the manufacture of Phase I & II clinical materials, supporting the development of autologous and allogeneic cell therapies.

Due to the presence of Phase II clinical materials, the completed modular facility complies with current Good Manufacturing Practices (cGMP) as they apply to the assessed risks of cell therapy. The Germfree bioGO® Modular Solution measures approximately 325m² (Gross) and will be installed on the roof of an existing hospital building.

The new FDA-GMP facility includes manufacturing suites, an administrative area, storage, and a supporting area. The modular solution will also include required mechanical and electrical equipment including AHU/s and chillers, as well as access to the facility. The new manufacturing program operated in this facility will comply closely with the latest FDA requirements and regulations.

Within the modules are four (4) fully independent ISO-7 cleanroom labs, built with dedicated entry and exit anterooms to mitigate vector cross-contamination. The concept also provides cryogenic containment for finished products, clean supply storage, administrative and support areas plus other areas and features required for a fully functional, unidirectional flow facility. Additionally, this facility is ‘temporary’ and can be dismantled and moved to another location with minimal demolition.

A mezzanine housing the Mechanical Plant was included in the scheme. The facility was installed on a 3rd floor terrace.

Other project details:
6 prefabricated modules, Unidirectional layout, Single pass air, egregation, 325m² mezzanine space.

Modular Biopharmaceutical Cleanroom/Production Facility

Project Title:ISO 7 – Cleanroom/Production Facility
Client:A National Public Health Organization
Project Type:Modular
Application:Biopharma
Location:Maryland, USA

Project Information:

A large National Public Health Organization had an urgent need for a new Tumor Infiltrating Lymphocytes (TIL) production facility to serve the organization’s surgery branch. This facility is for the relocation of the manufacturing programme, which complies with the latest FDA-GMP requirements and regulations.

Germfree’s bioGO® Modular Solution involves approximately 558m² (Gross) of manufacturing suites, lab, office, QA/QC, storage, and supporting area, all constructed within ten (10) Factory Acceptance Tested (FAT) modules. Modules are completely built offsite, tested, then delivered and installed. The “Turnkey” system from Germfree includes necessary mechanical and electrical equipment, including AHU/s and chillers to support operations.

The scope included a large mezzanine space which made the facility self-sustaining and turnkey. The facility connected to campus utilities.
Other project details: 10 prefabricated modules, Bidirectional layout, Single pass air, Segregation, >604m² mezzanine space.

Mobile Pharmaceutical
BSL-3 Laboratory

Project Title:BSL-3 Mobile Lab
Client:A National Public Health Organization
Project Type:Mobile
Application:Biocontainment
Location:West Point, PA

Project Information:

This Mobile BSL-3 Laboratory is self-contained on a custom-designed mobile lab trailer. The facility’s design includes two Class II Type 2a Biological Safety Cabinets (BSC), a computer workstation within the laboratory, and a Laboratory Sterilizer for sterilizing both culture mediums and liquids. Primary and secondary barrier structures offer protection for scientists and isolate infectious agents. This facility was delivered in November of 2020 to a large pharmaceutical company in Pennsylvania to be used in biological research involving work with infectious agents that will be cultured, incubated, and isolated.

Uniquely robust and designed for rigorous and repeated use, Germfree’s Mobile Laboratories are suited well for large pharmaceutical companies facing growing demand and capacity needs. These labs are ready to engage in complex processes and research, while meeting strict guidelines for operation and safety. In a rapidly changing world, Germfree’s mobile laboratories can be deployed in a compressed timeline when compared to traditional laboratory construction, offering flexibility of size and location.

Germfree’s bioGO® Mobile Cleanrooms and Biocontainment Suites are available in standard and custom configurations to meet a wide variety of cGMP development, manufacturing, and aseptic training applications. Each facility is engineered and constructed to meet or exceed the current US and EU Good Manufacturing Practices, ISPE Baseline Guides®, ISO 14644, CDC NIH BMBL guidelines for BSL Laboratories, and other relevant standards. Our mobile (trailer/vehicle-based) units deliver critical cleanroom and biocontainment capacity throughout the world. With a deployable rental fleet available, our Offsite Built, Process Ready facilities offer accelerated timelines and are
provided with full integration of equipment, utilities, and services.

Mobile cGMP
Cleanroom

Project Title:Artificial Cell Technologies
Client:A National Public Health Organization
Project Type:Mobile
Application:Biopharma
Location:New Haven, CT

Project Information:

This Mobile cGMP Cleanroom Facility on a semi-trailer chassis (420 ft2 / 39 m2 gross area) consists of two (2) ISO 7 cleanrooms and ISO 5 workstations, including gowning areas and an office. Both cleanrooms are equipped with Class II A2 Biosafety Cabinets. This project was funded by the National Institute of Allergy and Infectious Diseases (NIAID) and was delivered to Artificial Cell Technologies (ACT) in New Haven, Connecticut in July of 2016 for running phase one and phase two clinical trials for a developmental malaria vaccine.

With new and emerging diseases posing a global threat, Germfree’s Mobile cGMP Cleanrooms present an opportunity to ramp up research, development, and trials in the interest of global health security. Laboratory and cleanroom space comes at a premium, and can be difficult to find or expand during periods of high demand. Germfree’s mobile and modular cleanroom facilities solve this key issue.

Germfree’s bioGO® Mobile Cleanrooms and Biocontainment Suites are available in standard and custom configurations to meet a wide variety of cGMP development, manufacturing, and aseptic training applications. Each facility is engineered and constructed to meet or exceed the current US and EU Good Manufacturing Practices, ISPE Baseline Guides®, ISO 14644, CDC NIH BMBL guidelines for BSL Laboratories, and other relevant standards.

Our mobile (trailer/vehicle-based) units deliver critical cleanroom and biocontainment capacity throughout the world. With a deployable rental fleet available, our Offsite Built, Process Ready facilities offer accelerated timelines and are provided with full integration of equipment, utilities, and services.