Customized chromatographic system for bioprocess purification
Streamline your bioprocess purification with advanced chromatography systems designed to optimize separation, purification, and filtration of complex biological molecules, ensuring high purity and consistent quality at every production stage.
AUSTAR’s custom chromatography system is designed to meet the precise requirements of pharmaceutical and biotech industries. This versatile equipment is crucial for purifying proteins, nucleic acids, and complex molecules in biopharmaceutical production. It utilizes a multi-method chromatographic approach—including gel filtration, ion exchange, and affinity chromatography—to ensure high-purity output for applications like monoclonal antibodies and mRNA vaccines.
The system is constructed with corrosion-resistant stainless steel (316L/1.4435) and adheres to ASME-BPE guidelines. Its control system seamlessly integrates with existing production lines, offering automatic control that aligns with GAMP5 and FDA 21 CFR Part 11 standards, ensuring strict compliance and traceability.
Engineered for flexibility, the chromatography system allows for customization of fillers and operation modes, including batch processes. It enhances solvent efficiency and reduces energy consumption, tailored for scalable production needs ranging from research laboratories to full-scale pharmaceutical manufacturing.
Included is a robust quality management system and comprehensive validation services, ensuring reliable operation and minimal downtime. AUSTAR provides extensive engineering support to tailor systems specifically for customer requirements, delivering documentation and technical support to facilitate implementation and ongoing operations.
Benefits
- Ensures high-purity outputs, crucial for sensitive biopharmaceutical applications.
- Integrates seamlessly into existing production lines, enhancing operational efficiency.
- Reduces compliance risks with full adherence to FDA and GMP standards.
- Offers flexible customization for varying process needs, improving versatility.
- Minimizes energy consumption through optimized motor control, reducing operational costs.
- Applications
- Polysaccharides,Proteins,Polypeptides,Vaccines,Nucleic acids,Antibiotics,Viruses,Biopharmaceuticals,Natural drugs
- End products
- Dna plasmids,Plant-based nutraceuticals,Heparin,Insulin,Monoclonal antibodies,Viral vectors for gene therapy,Penicillin,Traditional chinese medicine extracts,Recombinant protein therapeutics,Mrna vaccines
- Steps before
- Extraction,Cell Culture,Fermentation
- Steps after
- Sterilization,Filling,Quality Control,Packaging
- Input ingredients
- protein,polypeptide,nucleic acid,vaccine,virus,antibiotics,polysaccharides,natural drugs
- Output ingredients
- purified protein,purified polypeptide,purified nucleic acid,purified vaccine,purified virus,purified antibiotics,purified polysaccharides,purified natural drugs
- Material
- Stainless Steel (316L/1.4435)
- Compliance
- ASME-BPE Guidelines,GAMP5,FDA 21 CFR Part 11
- Control System
- Automatic Control Design
- Chromatography Methods Supported
- Gel Filtration,Ion Exchange,Affinity,Hydrophobic,Reverse Phase
- Application
- Purification of Proteins,Polypeptides,Nucleic Acids,Vaccines
- Chromatography Methods
- Gel Filtration,Ion Exchange,Affinity,Hydrophobic,Reverse Phase
- Purification Stage
- Coarse,Intermediate,Fine
- Automation Level
- Manual / PLC
- Control System
- GAMP5 Compliant
- Batch vs. Continuous Operation
- Batch
- Material Compatibility
- Stainless Steel 316L/1.4435
- Corrosion resistance
- Stainless Steel (316L/1.4435)
- Shell material
- Stainless steel (316L/1.4435)
- Control system
- GAMP5 compliant
- FDA 21 CFR Part 11
- Design guidelines
- ASME-BPE
- Chromatography method customization
- Gel filtration,ion exchange,affinity,hydrophobic,reverse phase
- Control system adaptation
- Adaptable to various methods
- Filler selection options
- Different fillers for chromatography types
- Stainless steel type
- 316L/1.4435
- 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.