Customized chromatographic system for bioprocess purification
In the biotech and pharmaceutical industries, precise purification of biological molecules is crucial. Challenges such as achieving high purity levels and meeting regulatory standards make it essential to have advanced chromatographic systems tailored to specific needs.
Adapt to various chromatography methods and materials
The customized chromatographic system by Austar is designed to meet various purification needs, accommodating techniques such as gel filtration, ion exchange, affinity, hydrophobic, and reverse phase chromatography. This flexibility ensures it can be used for proteins, peptides, nucleic acids, vaccines, viruses, antibiotics, polysaccharides, and natural drugs at various purification stages, from coarse to fine purification. Stainless steel construction (316L/1.4435) ensures durability and compliance with ASME-BPE standards. The system’s automatic control design follows GAMP5 guidelines and adheres strictly to FDA 21 CFR Part 11 requirements, facilitating regulatory compliance. Additionally, a robust quality management system provides comprehensive technical documentation and validation services, streamlining the implementation process.
Benefits
- Supports multiple chromatography techniques
- Stainless steel construction for durability
- Comprehensive regulatory compliance
- Customizable to specific purification needs
- Robust quality management system