The biologics market is experiencing high growth. At IntellectiveBio, we understand the increasingly contract manufacturing requirements for biological drugs and also world-class facilities, industry-leading expertise that can be employed. We can provide our clients end-to-end, fully integrated commercial manufacturing services for both drug substances and drug products under full cGMP conditions. We are continuously making improvements in capacity, infrastructure and technology, and dedicated to earn your business year after year with exceptional quality and effective cost, plus flexibility to adapt to changes in your market.
Rich biopharmaceutical manufacturing experience
Valid quality control and assurance
Strong regulatory compliance
Superior track record
Technology transfer and process scale-up expertise
Stable supplier partnership
苏州智享严格按照ICH Q5和产品申报地区法规要求制备和管理细胞库，采用C+A或B+A 环境进行细胞库的制备。细胞库实行严格的权限控制和出入库管理，保护客户知识产权的同时，确保满足法规符合性要求。
IntellectiveBio prepares cell banks in grade C+A or grade B + A area, in accordance with ICH Q5 and other related laws and regulations. The storage rooms for cell banks implements strict access control and incoming/outgoing management, which help protecting the intellectual property rights of our clients while ensuring regulatory compliance at the same time.
At IntellectiveBio, the core equipment used for drug substance production are all from global-leading suppliers. The upstream is equipped with GE 200L, 500L, and 2000L disposable bioreactors, and the downstream is equipped with GE chromatography systems and Millipore filtration systems. We can offer manufacturing services with different quality needs and at different stages of the project.
IntellectiveBio drug product production utilizes imported Watson-Marlow filling line, Tofflon lyophilization machine and automatic feeding/discharging system. The parts which may directly contact the product all use disposable consumables. We have the ability to produce small-volume injections and sterile lyophilized vails.