Pilot Plant

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Facility Overview

Built to comply with international GMPs and provide one-stop service from cell-line development, process development, representative material for toxicology studies, to GMP manufacturing of clinical drug substance and drug Product at the same site, the CMAB technical development center is located in BioBAY, Suzhou Industry Park, China. The facility occupies an area of 10,500m² (113,000ft2) across three levels.

As home to a team of more than 150 employees, the site has a 3,700m² of laboratories and a 3,000m² GMP manufacturing, with reactor capacities ranging from 20L to 2000L.

There are separate functional areas for:

• Process Development Laboratories
• Analytical Development Laboratories
• Quality Control Laboratories
• Clinical Drug Substance Manufacturing
• Clinical Drug Product Manufacturing
• Raw Material and Product Warehouse
• Utilities
• Offices and staff amenities.

CMAB has advanced GMP facilities and manufacturing capabilities ranging from cell banking to drug substances and aseptic drug products manufactured according to global GMP requirements. This enables us to offer the flexibility to adapt to market changes and product development strategy. Segregation of manufacturing suites and single-use equipment allow CMAB to handle multiple products in parallel, while minimizing the risk of cross-contamination and facilitate rapid product change-over.

In the upstream area, four independent GMP production lines equipped with disposable bioreactors of 200, 500, 1,000, and 2,000 liters are strictly segregated to culture multiple products at the same time and minimize the risk of cross-contamination.

Two separate downstream purification lines equipped with ÄKTA Process, ÄKTA Ready, Millipore, Mobius System, and UFDF advanced equipment can handle cell culture fluid from 200 to 2,000 liters simultaneously.

Raw Material and Product Warehouse

CMAB is equipped with 700m2 GMP 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: room temperature, 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

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