AdvanceTEC the industry leader of integrated cleanrooms for gene therapy clients across the technology spectrum. Gene therapy innovators using technologies such as CRISPR, GTMP, SCTMP and TEMP have benefited from AdvanceTEC’s cleanroom design-build expertise. Our in-house team of segment experts are skilled in process integration of single use disposable equipment platforms for clinical stage and volume manufacturing applications. Speed, accuracy, and certainty of cost & schedule are hallmarks of AdvanceTEC’s cleanroom integration and our delivery of total performance for you.
Typical Gene Therapy Cleanroom Considerations
Gene therapy cleanrooms are purpose-built facilities customized to the unique processes they enable. While every gene therapy cleanroom is different, there are common considerations that span the various gene therapy applications and technology platforms:
Gene Therapy Cleanroom Design Considerations
MAL (Material Airlocks) / PAL (Personnel Airlocks)
Door interlocking and personnel flow patterns
Pressure cascades
Process equipment configuration and access
HVAC configurations and air flow segregation
Down flow booths or LAF (laminar air flow) modules
Low wall returns
Process distribution
Environmental monitoring
ISO classification, temperature & humidity
Viewing, monitoring, security cameras
Gowning and cleaning protocols
Gene Therapy Facility and Systems Experience
N+1 redundant utilities
Bioreactors
Process utility panels and distribution hook-ups
VHP (Vapor Hydrogen Peroxide)
WFI (Water for Injection) generation and distribution
BMS (Building Management System) controls & door interlocks
Environmental monitoring equipment (viable and nonviable particle counters)
Analytical equipment cell culture suites
Common Gene Therapy Cleanroom Specifications
Gene therapy cleanrooms are comprised of various ISO performance classifications ranging from ISO 5 (Class 100), ISO 6 (Class 1,000), ISO 7 (Class 10,000), ISO 8 (Class 100,000) backgrounds and CNC (Controlled Non-Classified) support zones. Critical supporting infrastructure such as N+1 redundancy across critical utilities, GMP Labs, cold boxes & environmental chambers, and process utilities such as WFI (water for injection), CO2, CDA, O2, WFI, RODI and N2 are common aspects of AdvanceTEC’s integrated project delivery. Specifications for gene therapy cleanrooms vary based on process requirements. Provided below are typical specifications:
There are various regulatory agencies to be considered for new gene therapy cleanroom facilities depending on the technology platform, facility type, scale and end market.
Good Manufacturing Practices (GMP)
US Food and Drug Administration (FDA)
National Institute of Health (NIH)
Office for Human Research Protections (OHRP)
Center for Biologics Evaluation and Research (CBER)
Regulations under Code of Federal Regulations (CFR)
European Union (EU Directive)
CAPABILITIES & Cleanroom IP
AdvanceTEC is the industry leading design & build cleanroom and process integration provider where experts with decades of segment experience apply the latest digital tools and technologies to deliver outstanding outcomes for customers.
.png){kind=small}
