Built to comply with international GMP and provide one-stop service from cell-line development, process development, Tox & Clinical material, to GMP manufacturing of Drug Substance & Drug Product at the same site, the CMAB technical development center is located in BioBay, Suzhou Industry Park, China. The facility occupies and area of 10,500m² (113,000ft2) 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
• 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.
Home to a team of more than 200 employees, the site has a 3,700m2 laboratories and a 3,000m2 GMP manufacuring, with reactor capacity ranging from 20L to 2000L.
Raw Material and Product Warehouse
CMAB is equipped with 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