CLINICAL FACILITY OVERVIEW

Built to comply with international GMP, the CMAB-C1 technical development center is located in BioBay Suzhou Industrial Park. The facility occupies and area of 6,500m2 (70,000ft2) across three levels.  There are separate functional areas for:

  • Process Development laboratories
  • Analytical Development Laboratories
  • Quality Control laboratories
  • Clinical Drug Substance
  • Clinical Drug Product
  • Raw material and Product warehouse
  • Utilities
  • Offices and staff amenities

High segregation within the manufacturing areas allows CMAB to handle multiple products without introducing risk of cross-contamination and mix-up.

Process Development Laboratories

Separate areas are provided for upstream development, downstream development, solution preparation, stability, and analytical development.

  • Three cell culture rooms for media development
  • Controlled-rate freeze system for cell banks
  • Quarantined Research Cell bank (RCB) storage
  • Cell culture bioreactors from 2L to 200L for process development, optimization, and production of gram-quantities
  • Filtration, chromatography, and ultrafiltration purification systems from milligram to gram quantities
  • Full analytical support
  • Formulation development equipment including controlled-rate freeze/thaw and pilot lyophilization

Quality Control Laboratories

The QC laboratories are composed of separate functional areas supporting Raw Material, Analytical and Biochemistry, Microbiology, real-time qPCR, Cell culture, and Stability Testing.

  • Sample receipt
  • Microbiology area includes cleanrooms (Grade D) for sterility testing within an isolator
  • PCR suite with separate rooms for preparation of reagents, extraction, and amplification
  • Controlled access room for stability testing under real-time and accelerated conditions: climatic and photostability chambers, 2-8°C, < ‒20°C, < ‒40°C, < ‒70°C
  • Controlled access room for cell bank storage
  • 600m2 laboratories with supporting special gases, storage, cold room, washroom

Clinical Drug Substance Area

1,500m2 of classified cleanrooms segregated into upstream and downstream areas:

  • Dedicated personnel locker rooms to bring all personnel into controlled-not-classified (CNC) conditions before entering production areas
  • Upstream area comprising
    • 5 x segregated inoculation rooms (Grade C)
    • 4 x segregated cell culture rooms (Grade D)
    • 2 x segregated harvest rooms (Grade D)
    • Supporting media preparation, media hold, washroom, In-Process Control (IPC), coldroom, and clean storage
  • Downstream area with two physically segregated lines
    • 2 x Purification rooms (Grade C)
    • 2 x Formulation rooms (Grade C)
    • Buffer preparation and storage
    • Separate column packing room
    • Supporting washroom, coldroom, and clean storage
  • Separated flow path for material entry, waste exit, and product exit

Separate area for freezing of Bulk Drug Substance (BDS).

Clinical Drug Product Area

350m2 of classified cleanrooms accessed from restricted controlled-not-classified (CNC) area.

  • Grade C rooms
    • Preparation and Formulation
    • Washing and sterilization
    • Clean storage
    • Vial washing and depyrogenation
  • Aseptic filling Grade A + Grade B

Separate inspection and packing area.

Raw Material & Product Warehouse

700m2 restricted access warehouse for controlling incoming goods, sampling, dispensing, storage of raw materials, and storage of bulk drug substance and finished products.

  • Separate sampling and dispensing cleanroom with additional clean workstations for open operations.
  • Controlled temperature storage for raw materials: Ambient less, 2-8°C, and ‒20°C
  • Separate controlled-access cellbank cryostorage room
  • Separate controlled-access room for Bulk Drug Substance (frozen)
  • Separate coldroom for storage of Drug Product
  • Separate areas for goods receiving, retained raw materials, staging dispensed raw materials, and rejected materials