Bioreactor for mammalian cell culture
In the pharmaceutical industry, cultivating mammalian cells for vaccines, mono-antibody drugs, or recombinant proteins requires precise control over the cell culture environment. Ensuring consistent conditions for sterility, temperature, and nutrient supply is critical for achieving high-quality results in both pilot and commercial-scale production.
Enables precise control for mammalian cell cultures
The bioreactor offered by Austar is a highly modular system designed specifically for mammalian cell culture applications. This bioreactor meets strict GMP regulations and follows ASME-BPE requirements, ensuring compliance and quality. The system includes a tank unit, stirring unit, jacket temperature control unit, and advanced automatic control systems. It supports various culture methods, such as cell suspension and micro-carrier cultures, making it adaptable to different production needs. Featuring clear, S88-standard programming, it records, stores, manages, and analyzes culture data effectively, complying with GAMP5. Audit tracking conforms to CFR 21 PART11, making it suitable for industries needing stringent regulatory adherence, such as vaccine and monoclonal antibody production.
Benefits
- Compliance with GMP and ASME-BPE requirements
- Supports multiple culture methods
- Advanced data management and analysis
- Detailed audit tracking conforming to CFR 21 PART11
- Scalable from pilot to commercial production