Stability of anti-immunotherapeutic antibodies in frozen human serum samples
Stability of anti-immunotherapeutic antibodies in frozen human serum samples
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DOI：
10.4155/bio.14.97
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发表时间：
2014-05-01
期刊：
影响因子：
1.8
通讯作者：
Deckert-Salva, Fabienne
中科院分区：
文献类型：
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作者：
Michaut, Lydia;Laurent, Nathalie;Deckert-Salva, Fabienne
背景：产生关于人类抗免疫治疗抗体稳定性的详尽数据。材料和方法：对100多名不同受试者在不同时间点采集的血清标本进行特异性ELISA分析，并在长期保存或多次冻融后再进行分析。对配基结合分析中产生的样品再分析采用了通用的接受标准，以及各种白皮书所提倡的替代更严格的接受标准。结果：抗免疫治疗性抗体在-80℃保存至少3.5年和3-12次冻融循环的未稀释血清中是稳定的。结论：所选择的样本涵盖了人类多克隆免疫反应的异质性，因此这种稳定性数据可以扩展到所有抗疫苗和抗药物抗体。
Background: To generate exhaustive data on the stability of human anti-immunotherapeutic antibodies. Materials & methods: Samples collected from over 100 different subjects at various timepoints were analyzed shortly after serum collection using specific ELISAs and re-analyzed after long-term storage or multiple cycles of freeze-thaw. The general acceptance criteria for incurred sample reanalysis for ligand-binding assays were applied, as well as alternative stricter acceptance criteria promoted by various white papers. Results: Anti-immunotherapeutic antibodies are stable in undiluted serum samples stored at -80 degrees C for at least 3.5 years and 3-12 freeze-thaw cycles. Conclusion: Samples were selected to cover the heterogeneity of the polyclonal human immune response, therefore this stability data can be extended to all anti-vaccine and anti-drug antibodies.