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Immunoinformatic Risk Assessment of Host Cell Proteins During Process Development for Biologic TherapeuticsNARA Subscribed
The identification and removal of host cell proteins (HCPs) from biologic products is a critical step in drug development. Despite recent improvements to purification processes, biologics such as monoclonal antibodies, enzyme replacement therapies, and vaccines that are manufactured in a range of cell lines and purified using diverse processes may contain HCP impurities, making it necessary for developers to identify and quant...
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