Regulatory agencies require at least one filtration step that will retain contaminating viruses during the purification of biologics derived from mammalian cell expression systems and this is a critical step for ensuring patient safety.
Parker domnick hunter's SciLog® NFF system if ideal for automating virus filtration. Our 'Open Architecture' approach allows you to use the best virus filters for your process from any vendor. The single-use manifolds we design to run with the system can incorporate SciPres single-use pressure sensors, allowing the system to ensure that the maximum validated pressure limits are not exceeded throughout the entire duration of the filtration step.
Our experience is that some engineers designing virus filtration steps are concerned that temperature limits for the step are specified and then not exceeded. SciTemp single-use temperature sensors measure and document the temperature of the process stream demonstrating to regulators that the temperature specifications were achieved.
Various virus inactivation methods can be used alongside filtration. One method is to adjust the pH to a precise level that inactivates viruses without destroying the protein, and maintaining this pH for a defined time period. The pH is then adjusted a second time back to a less aggressive value. An alternative approach is to meter in a detergent to a specific concentration for a defined time period.
Parker domnick hunter's LabTec automated dispensing system and ChemTec automated metering system enable the addition of pH adjustment solutions or detergents in a controlled manner while minimizing the risk of pH overshoots and overdosing which can lead to deviations and quality investigations.
Products for Virus Control
Automated Single-Use Bioprocessing Systems
Pre-Calibrated Single-Use Sensors
Fluid Transfer and Storage