Low pH Flow-Through Virus Inactivation
Maintaining viral safety in biologics production is essential, but manufacturers often face challenges in balancing effective virus inactivation with product quality. Traditional batch-based approaches, particularly low pH inactivation during protein purification, can create process bottlenecks and impact product stability. As a result, there is a growing demand for continuous virus inactivation solutions that improve efficiency and help accelerate time-to-market.
Innovative Viral Inactivation Solutions
Harnessing the Power of pH for Viral Risk Mitigation
Sartorius offers advanced solutions, including continuous low pH virus inactivation systems like Pionic® Spin and innovative single-use technologies that support robust viral clearance strategies. Our comprehensive portfolio addresses key process challenges, delivering reliable, scalable virus inactivation solutions that meet stringent regulatory clearance requirements.
Supporting Products & Services
Learn More About Viral Inactivation
Advanced Viral Inactivation: Sartorius Expertise at Your Service
At Sartorius, we excel in providing cutting-edge solutions for viral inactivation, ensuring the efficacy of biologics. Our expertise can guide you through multiple aspects to ensure optimal performance:
- Smooth Integration of Ready-for-use Technologies: Our viral inactivation portfolio stands out with smooth integration of ready-for-use technologies, offering flexible, integrated solutions like the Pionic® Spin for low pH flow-through inactivation.
- Precision with Advanced pH Controller: The pH controller ensures precision and minimal drift, enhancing the reliability of the inactivation process.
- Comprehensive Documentation and Validation Services: Sartorius provides comprehensive documentation, validation services, and application testing, enabling faster regulatory compliance and tailored user support.
- Risk Minimization and Accelerated Time-to-Market: By leveraging Sartorius' expertise, you can minimize risks and accelerate your time-to-market, ensuring your biologics are reliable and effective.
Frequently Asked Questions
Viral inactivation is a critical step in biopharmaceutical manufacturing, especially for products like monoclonal antibodies and protein-based vaccines. Its primary purpose is to render any potential viral contaminants within the product non-infectious.
Low pH inactivates viruses primarily by disrupting their structure, particularly targeting components that are crucial for their infectivity. This method is particularly effective against enveloped viruses, which possess an outer lipid membrane.
Tank-based and flow-through (or continuous) virus inactivation refer to two fundamental approaches used in biopharmaceutical manufacturing. The key difference lies in how the product is exposed to the inactivating conditions (e.g., low pH) and how the process flows.
Unlike batch processing, flow-through virus inactivation processes the product as it continuously moves through a specialized "plug flow" reactor. The goal is to achieve the required inactivation kinetics during flow, eliminating the need for large hold tanks.
Virus inactivation chemically or physically modifies viruses to make them non-infectious, but the viral particles may still be present. Virus removal physically separates and eliminates viral particles from the product stream, typically through methods like nanofiltration or chromatography. Both are crucial components of a robust viral clearance strategy.
Continuous virus inactivation offers several key advantages over batch approaches:
- Reduced footprint: Eliminates the need for large hold tanks, saving valuable cleanroom space
- Increased efficiency: Enables faster processing and higher throughput by integrating into continuous manufacturing workflows
- Potentially improved product quality: Shorter exposure to harsh conditions can help reduce protein aggregation or degradation
- Enhanced automation: Easier to automate and integrate within an end-to-end continuous process
- Reduced cleaning and validation effort: Often implemented with single-use systems, minimizing cleaning requirements