Viral Clearance Prediction Kits
BSL-1 compatible viral clearance studies
Viral contamination is an inherent risk during the manufacture of therapeutic products that can lead to serious health implications and plant shutdowns. Therefore, international regulatory agencies require sponsoring companies to validate the “viral clearance efficacy” of their individual downstream purification process steps before clinical trials or commercial approval [1].
Live spiking studies require specialized contract research organizations (CROs) and trained personnel, which is costly and requires complex logistics. These hurdles deter companies from analyzing viral clearance during the years of small-scale process development. As a result, companies spend considerable resources optimizing manufacturing processes before assessing their viral clearance efficacy. Unfortunately, this increases the risk of validation failure during later stages, forcing companies to invest additional time and money redeveloping process steps, which in turn, could postpone regulatory approvals and delay patients’ timely access to therapies.
De-risk your downstream purification process
Cygnus provides a unique solution that enables viral clearance prediction early in downstream purification development. Now, through the use of BSL-1 compatible viral clearance kits, you can easily and economically quantify viral clearance for downstream process steps in your own lab, on your own timeline.
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