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Application Note: Viral clearance from mAbs with HCPure™ and Q PuraBead® adsorbents Biopharmaceutical products, such as monoclonal antibodies (mAbs) derived from mammalian systems, require evidence of viral clearance in the manufacturing process for approval. Viral spiking studies are utilized to determine the efficacy of viral clearance in downstream purification methods. Minute Virus of Mice (MVM) is a small non-enveloped parvovirus which has been found as an adventitious contaminant of CHO derived drug products and which is commonly used for viral clearance studies. Cygnus Technologies has developed a BSL-1 compatible surrogate of MVM which and can be used in viral clearance studies to predict the removal of MVM. Type C Retrovirus Like Particles (RVLP) are endogenously produced during CHO cell expression. Viral clearance is generally demonstrated using a model mammalian virus, Xenotropic Murine Leukemia Virus (XMuLV); however, the establishment of RVLP quantification methods have made it possible to track the removal of actual endogenous RVLP throughout the downstream process. Astrea Bioseparations partnered with Cygnus to perform MVP and RVLP Spiking Studies on HCPure™ mixedmode and Q PuraBead® Anion Exchange Chromatography resins, analyzing the samples to demonstrate MVP/RVLP concentration and Log Reduction Values (LRV’s) for each study.
Application note: Viral Clearance from mAbs with HCPure™ and Q PuraBead® adsorbents
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