Mitigating Immunogenicity: A Strategic Approach to Patient Safety
The primary concern with Host Cell Proteins is not that they make the drug less effective, but that they can make the patient sick. Immunogenicity—the ability of a substance to provoke an immune response—is the "ghost in the machine" for biologics. Even at very low concentrations, certain HCPs can act as catalysts that cause the patient's body to produce anti-drug antibodies (ADAs)....
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