EXPERT ENVIRONMENTS
CASE STUDY Modular Biopharmaceutical Cleanroom/Production Facility
CASE STUDY Modular Cell and Gene Therapy ISO 7 Cleanroom Facility
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.
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.
Other project details: 10 prefabricated modules, Bidirectional layout, Single pass air, Segregation, >604m² mezzanine space.
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.
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