Arcadia CGMP Facility

Modern manufacturing for next-generation therapies.

Opened in 2022, our state-of-the-art Arcadia cGMP facility offers manufacturing services for cell and gene therapy clinical and commercial use. This ultra-modern facility was built with one over arching purpose in mind – to manufacture for viral vectors, critical reagents, and cell-based products in the most efficient way
possible. With four flexible manufacturing suites, full automation throughout, and in-house analytical testing capabilities, let us help you bring your product to the clinic on time and with the high quality that you expect.

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