'Immunogenicity testing requirements' presentation slideshows

immunogenicity assay

Immunogenicity is the ability of a particular substance, such as an antigen or epitope, to induce an immune response in the body of a human or animal. Immunogenicity assessment is integral to biologic drug development. Biotherapeutics such as proteins, antibodies, conjugated peptides and oligonucleotides can induce an adverse immune response in the body, leading to the development of anti-drug antibodies (ADAs), which can potentially threaten patient safety (causing allergy, autoimmunity, etc.). ADAs with neutralizing capacity are called neutralizing antibodies (NAbs). NAbs can reduce the efficacy of drugs by inhibiting their biologic activities. Assessment of ADAs as well as NAbs form the basic part of immunogenicity testing. Profacgen provides immunogenicity assay to test the ADAs and NAbs generated in the host organism upon biologic drug usage, and can best help our customers accelerate their drug discovery and development programs.

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