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Custom Biologics does not develop its own therapeutics but provides GLP/GxP-compliant bioanalytical assay development, validation, and testing services supporting the functional characterization, potency/bioactivity assessment, pharmacokinetics, immunogenicity studies for biologic drugs, vaccines, cell/gene therapies at all stages of drug development. It has supported over 200 pre-clinical/CMC and clinical immunogenicity studies for more than 125 clients worldwide over its >20-year history.
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