Process Impurities: Don't Let PEI Or HCP Derail Your Biotherapy

Many impurities are present in or generated during biotherapy manufacturing. We will review strategies within product characterization to de-risk the manufacturing process for monoclonal antibodies (mAb) and cell and gene therapies. We will discuss how to effectively detect and characterize host cell proteins (a factor in mAb therapies and cell and gene therapies), and polyethylenimine (PEI), used in cell and gene therapy products.

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