Arcadia cGMP Facility Capabilities
- Process development capabilities: T cells, CAR-T, NK cells, iPSCs, MSCs, HSCs, TILs, Multicells, lentivirus, retrovirus, and more
- End-to-end manufacturing solutions: for cGMP clinical and commercial use
- Analytical/bioanalytical testing: microorganism identification, bioassay development, micro/QC testing to support full Certificates of Analyses
- Cryopreservation: multiple CRFs onsite with electronic product sample storage tracking system
- Fully integrated digital services: BMS/EMS monitoring, inventory management, electronic validation system for commissioning and qualification
Arcadia Facility Fast Facts
11,250 sq. ft.
cGMP manufacturing space
14,000 sq. ft.
support space
1,000 sq. ft. x 4
fully validated ISO 7/8 modular cleanroom suites
Additional Specifications
- Each suite equipped with 12 AES Omni™ cleanroom gas utility raceways for CO2, O2, N2
- Single pass air delivered by dedicated HVAC air handlers (for component decontamination or dedicated manufacturing)
- MAL / PAL airlocks to each suite
- cGMP-compliant materials of construction Including epoxy floors throughout
- BOM kitting capabilities with separate BOM storage
- Micro-QC contamination programs
- Simple HEPA-covered pass-throughs for samples and product
Interested in Preclinical Discovery & Research? See Our Research Facility
Additional Specifications
- Unidirectional flow for personnel, raw materials, products, waste
- Single-use component manufacturing
- Cryopreservation and cold chain capabilities
- PW System w/ point of use sterile filtration for facility cleaning
- ERP Electronic Materials Management and Patient Material
Handling Controls, full barcode tracking - Client-specific warehouse storage
- Separate quality released goods warehouse
- 1250 KW backup generator and UPS
- Dedicated servers and data rooms for client