血液处理和样本储存对生物治疗药物及抗药物抗体稳定性的影响。
Effects of blood processing and sample storage on the stability of biotherapeutics and anti-drug antibodies.
作者信息
Andisik Matthew, DeStefano Lisa, Stefan Colin, Gathani Meghna, Laurino Kevin, Lai Vicky Ch, Rajadhyaksha Manoj, Torri Albert, Shao Weiping
机构信息
Department of Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA.
出版信息
Bioanalysis. 2015;7(11):1325-35. doi: 10.4155/bio.15.66.
BACKGROUND
Pre-analytical factors such as sample processing, handling or storage could affect the stability of biotherapeutics and anti-drug antibodies in clinical samples, potentially impacting the pharmacokinetic and immunogenicity assessments.
METHODS
We used sarilumab, a fully human IgG1 monoclonal antibody, and evaluated the stability of sarilumab (both functional and bound forms) and anti-sarilumab antibodies in blood samples during serum collection and the impact of various processing conditions on the analyte stability in serum for long-term storage. We also assessed the incurred sample stability of these analytes in samples from clinical studies.
CONCLUSION
Assessment of analyte stability can provide relevant information about sample stability under different pre-analytical conditions and improve the confidence in the validity of bioanalytical data generated.
背景
诸如样本处理、处理或储存等分析前因素可能会影响临床样本中生物治疗药物和抗药物抗体的稳定性，从而可能影响药代动力学和免疫原性评估。
方法
我们使用了全人源IgG1单克隆抗体萨瑞鲁单抗，评估了血清采集过程中血液样本中萨瑞鲁单抗（功能形式和结合形式）和抗萨瑞鲁单抗抗体的稳定性，以及各种处理条件对血清中分析物长期储存稳定性的影响。我们还评估了这些分析物在临床研究样本中的实际样本稳定性。
结论
分析物稳定性评估可以提供有关不同分析前条件下样本稳定性的相关信息，并提高对所生成生物分析数据有效性的信心。
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