Viral Safety Strategy for mAb: Prevent, Detect, Remove
Prevent:Raw material control and barrier technology Detect:Testing for presence of viruses Remove:Process’s ability to reduce levels of infectious viruses
Our approach to viral safety provides a tailored solution that considers the production cells, raw materials, testing plans, downstream purification operations and experience of the biomanufacturer. We rely on the principles of the biosafety triangle ‘prevent, detect, remove’ to evaluate options for mitigating the risk of viral contamination in the upstream process and for maximizing viral clearance in downstream purification. This holistic approach integrates upstream and downstream, providing confidence in the safety of the entire production process.