This single-use bioreactor system is designed for mammalian cell culture, microbial fermentation and seed expansion in biopharmaceutical process development, pilot trials and commercial manufacturing. It consists of gamma-irradiated disposable bioprocess bag, integrated impeller assembly, sparger, sensor ports and matched temperature-controlled support vessel frame, eliminating traditional stainless steel vessel CIP/SIP cycles completely.
Constructed with low-extractable, biocompatible film material verified by full E&L testing, the single-use bag avoids cross-contamination risks between batches, drastically reduces validation workload and turnaround time between production runs. Equipped with accurate closed-loop control of temperature, pH, dissolved oxygen, agitation speed and overlay gas flow, it delivers homogeneous mixing and stable mass transfer performance consistent with stainless steel bioreactors, supporting fed-batch, repeated batch and continuous perfusion culture modes.
The modular control unit follows ISA-88 batch control specifications, enabling recipe management, unattended operation, real-time data logging and complete audit trails to satisfy global GMP and data integrity requirements. No onsite piping cleaning and sterilization infrastructure is required; equipment setup and changeover can be finished rapidly, significantly shortening project construction cycles and lowering upfront capital investment for new workshops.
Available in multiple working volumes ranging from lab scale to commercial production scale, it fits perfectly for monoclonal antibodies, viral vectors, vaccines, recombinant proteins and advanced therapy product development, especially suitable for multi-product flexible production facilities and fast-track clinical material manufacturing projects.
