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首页> 外文期刊>Clinical immunology: The official journal of the Clinical Immunology Society >Considerations for optimization and validation of an in vitro PBMC derived T cell assay for immunogenicity prediction of biotherapeutics.
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Considerations for optimization and validation of an in vitro PBMC derived T cell assay for immunogenicity prediction of biotherapeutics.

机译：优化和验证体外PBMC衍生的T细胞测定法用于生物治疗药物免疫原性预测的考虑因素。

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摘要

An immune response to a biotherapeutic can be induced when the therapeutic is processed and presented by antigen presenting cell to T helper cells. This study evaluates the performance of an in vitro assay that can elicit antigen specific effector T cell responses. Two biotherapeutics with known clinical immunogenicity [FPX1 and FPX2] were assessed for their ability to induce antigen-specific IFN-gamma secreting T cells in peripheral blood mononuclear cells (PBMC). The 24 amino acid peptide component of FPX1 elicited an antigen-specific response in 16/34 (47%) individual naive healthy donors. This in vitro effect was consistent with high rate of immunogenicity which was observed when this drug was administered in clinical trials. FPX2 did not induce antigen-specific T cells in vitro, which correlates with the low rate of development of anti-drug antibody responses to this molecule in the clinic. The assay has the potential to predict immunogenicity and help in the selection of biotherapeutics at the early development stage of a clinical candidate.
机译：当治疗剂被抗原呈递细胞处理并呈递给T辅助细胞时，可以诱导对生物治疗剂的免疫应答。这项研究评估了可以引起抗原特异性效应T细胞反应的体外测定的性能。评估了两种具有临床免疫原性的生物治疗药物[FPX1和FPX2]诱导外周血单核细胞（PBMC）中抗原特异性IFN-γ分泌性T细胞的能力。 FPX1的24个氨基酸的肽成分在16/34（47％）的个体初次健康供体中引起抗原特异性应答。这种体外作用与在临床试验中给予该药时观察到的高免疫原性相一致。 FPX2不能在体外诱导抗原特异性T细胞，这与临床上对该分子的抗药物抗体反应的发展速度较低相关。该测定法有潜力预测免疫原性，并有助于在临床候选药物的早期开发阶段选择生物疗法。

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