CAR-T Experience

Cures to cancer are coming to market at a rapid pace – small cell, large cell, soft tissue, blood . . . and the list goes on.  AdvanceTEC’s industry leading cleanroom integration has proven successful serving ground breaking companies with novel cancer curing remedies.  In a frontier where your process is the cure, our turn-key design build and process integration platform has been particularly advantageous to clients like you.  Now is the time to work with AdvanceTEC, the leader in cleanroom integration; we’re committed as you are with time to market and bringing your cure to the world.

Typical CAR-T Cleanroom Considerations

Although every cleanroom and process has specific requirements and challenges, below are common cleanroom considerations for CAR-T cleanroom and process applications:
CAR-T 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
CAR-T Facility and Systems Experience
  • N+1 redundant utilities
  • Biosafety hoods
  • Cell washers
  • Bioreactors
  • Process utility panels & distribution hook-ups
  • WFI (Water for Injection) generation and distribution
  • BMS (Building Management System) controls and door interlocks
  • Environmental monitoring equipment (viable and nonviable particle counters)
  • Analytical equipment

Common CAR-T Cleanroom Specifications

CAR-T and other forms of immunotherapy / oncology cleanrooms are predominantly comprised of ISO 5 Grade A or B zones with ISO 7 Grade C or ISO 8 Grade D backgrounds.  Critical supporting infrastructure such as N+1 redundancy of mission-critical utilities, GMP Labs, cold boxes and environmental chambers, quarantine and process utilities such as WFI (water for injection) and N2 are common elements of AdvanceTEC’s integrated project delivery.  Specifications for CAR-T 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 CAR-T Regulatory Considerations

There are various regulatory agencies to be considered for new CAR-T cleanroom facilities depending on the technology platform, facility type, scale, and end market, including:
  • Good Manufacturing Practices (GMP)
  • US Food and Drug Administration (FDA)
  • Center for Biologics Evaluation and Research (CBER)
  • European Union (EU)

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. 

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