Gene Therapy Cleanrooms
Gene Therapy Cleanrooms
Clinical Stage and Volume Production Cleanrooms
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 havebenefitedfrom 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’scleanroom 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:
ISO Classification
- ISO 4 – (Class 10) – 300-540 ACPH
- ISO 5 – (Class 100) – 240-480 ACPH
- ISO 6 – (Class 1,000) – 150-240 ACPH
- ISO 7 – (Class 10,000) – 60-90 ACPH
- ISO 8 – (Class 100,000) – 5-48 ACPH
European Standard
- Grade A
- Grade B
- Grade C
- Grade D
- Controlled Non-Classified (CNC)
Important Gene Therapy Regulatory Considerations
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)
