Bioreactor for mammalian cell culture
Optimize your biopharmaceutical production with precise control over cell culture conditions, ensuring high-yield and quality for vaccines, monoclonal antibodies, and therapeutic proteins.
Cultivates and Manages Mammalian Cell Cultures
The bioreactor from AUSTAR is engineered for biopharmaceutical companies focusing on vaccines, monoclonal antibodies, and recombinant protein production. It features a modular design for scalability from lab to commercial-scale operations. The system employs temperature-controlled stirring and precise feeding mechanisms to cultivate mammalian cell cultures effectively. Its automation aligns with S88 standards and supports CFR 21 PART 11 compliance through comprehensive data recording and trend analysis functionalities. Designed in adherence to GMP and ASME-BPE guidelines, the bioreactor ensures high-quality cell culture batch processing. Integration with other units, such as biological fermentation tanks and chromatography equipment, is seamless, optimizing production flow and maintaining efficiency. With a focus on reducing maintenance time, this bioreactor includes features for easy cleaning. Optional customization allows tailoring to specific process requirements, supported by AUSTAR’s engineering and validation services.
Benefits
- Scales efficiently from lab to commercial production, minimizing process disruptions.
- Enhances data integrity and compliance with automated record-keeping compliant with CFR 21 PART 11.
- Reduces operational costs through optimized temperature and feeding controls.
- Integrates seamlessly into existing production lines, improving overall process efficiency.
- Adheres to strict GMP standards, ensuring product quality and regulatory compliance.
- Applications
- Mono-antibody drugs,Biopharmaceuticals,Recombinant protein drugs,Vaccines
- End products
- Rabies vaccine,Recombinant therapeutic proteins,Monoclonal antibodies,Foot-and-mouth disease (fmd) vaccine
- Steps before
- Engineering Design,Processing,Project Management,Validation
- Steps after
- Sterilization,Packing,Data Recording,Data Analysis
- Input ingredients
- mammalian cell culture,cell suspension culture,plate carrier culture,micro-carrier culture,feedstock,media
- Output ingredients
- biological drugs,antibody drugs,vaccines,rabies vaccine,foot-and-mouth disease vaccine,recombinant protein drugs
- Market info
- Austar is known for specializing in the design and manufacture of engineered-to-order industrial equipment, particularly in the pharmaceutical and biotechnology sectors, offering solutions that focus on quality, innovation, and meeting specific customer requirements.
- Compliance,Certification
- GMP,ASME-BPE
- Automation
- S88 structured,electronic record/e-signature CFR 21 PART11
- Historical Data Management
- Data recording,storage,trend chart display
- Control System
- Automatic control unit
- Tank Composition
- Tank unit,stirring unit,jacket temperature control unit
- Batch Operation
- Batch production capability
- Batch vs. continuous operation
- Batch
- Automation level
- PLC / SCADA
- CIP/SIP
- CIP 121°C / SIP 135°C
- Cleaning method
- AUTOMATIC
- Data Management
- Historical data recording,storage,management
- Compliance
- GAMP5,CFR 21 PART11
- Control System Standard
- S88
- Design Compliance
- GMP,ASME-BPE
- Biological compatibility
- Yes
- Cleanability
- GMP compliant
- Corrosion resistance
- High
- Density/particle size
- Customizable
- Abrasion resistance
- Moderate
- Thermal compatibility
- High
- GMP Compliance
- Yes
- ASME-BPE Requirements
- Yes
- CFR 21 PART 11
- Yes
- GAMP5
- Yes
- Tank shape
- Cylindrical
- Tank size
- Lab to commercial scale
- Footprint
- Modular design
- Discharge method
- Automatic
- Control Panel Type
- HMI/PLC
- Integration Possibilities
- Automated Data Recording
- Modular Design
- Yes
- Structural Design Combination
- Flexible