GMP Facility
cGMP Plant :


IntellectiveBio GMP facility is designed and constructed in accordance with the current regulations and guidelines in China, the United States and the European Union. Each functional area is fully prepared, and the layout for the flow of people and material is reasonable to ensures that the facility meets global regulations for biological product manufacture requirement.


As a service provider focusing on the contract development and manufacture organization (CDMO) of biologics, IntellectiveBio has facilities using the design concept (uni-directional flow and single use production system) to reduce the risk of contamination and cross-contamination. This protects the interests of clients and patients.

The Feature of Uni-Directional Flow:
  • 产品流向按照工艺步骤单向流动

    Manufacture work flow is one-way flow during process steps

  • 人物流,污物流向在各功能间保持单向流动并退出

    Personnel flow, material flow and waste flow are separated and one-way flow in each function area

The Feature of Single-Use Production System:
  • 采用一次性无菌封闭系统进行原液的生产

    Utilize sterile disposable close system on DS manufacturing

  • 采用一次性无菌耗材系统进行无菌灌装产品的生产

    Utilize disposable sterile consumables for DP production


The HVAC system, purified water system, and water-for-injection system have been fully qualified, and a comprehensive routine monitoring plan has been established to meet the manufacturing process and regulatory requirements, which continually ensure the product quality for our clients.