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.
Manufacture work flow is one-way flow during process steps
Personnel flow, material flow and waste flow are separated and one-way flow in each function area
Utilize sterile disposable close system on DS manufacturing
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.