IVEN provides professional services in engineering design, processing and manufacturing, project management, verification, and after-sales service. It provides biopharmaceutical companies such as vaccines, monoclonal antibody drugs, recombinant protein drugs, and other biopharmaceutical companies with individualization from laboratory, pilot test to production scale. A full range of mammalian cell culture bioreactors and innovative overall engineering solutions. The design and manufacture of bioreactors strictly follow GMP regulations and ASME-BPE requirements, adopt professional, user-friendly, modular design, and perfect and flexible structural design combinations to meet the requirements of cell batch culture.
It is composed of a tank unit, a stirring unit, a jacket temperature control unit, a four-way air inlet unit, an exhaust unit, a feeding and replenishing unit, a sampling and harvesting unit, an automation control unit and a common medium unit. The self-control program complies with the S88 international standard, with a clear structure, complete historical data recording, storage, management, trend graph display and training data analysis functions, in line with GAMP5; audit trail function (electronic record/electronic signature), in line with CFR 21 PART11.
The product is suitable for the full-suspension culture, sheet carrier culture and microcarrier culture of biological drugs such as antibodies and vaccines (such as rabies vaccine, FMD) and other biological drugs in the pilot and production scale.