Parul Sirohi, Kelly Hainline, Heather Bullock, Sihe Wang, Robert J Konrad, Yi Wen
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引用次数: 0
Abstract
Biotherapeutics have the potential to elicit unwanted immune responses that can lead to the production of anti-drug antibodies (ADA). It is critical that ADA responses are detected, characterized, and monitored to understand the safety and efficacy of a drug. ADA samples must remain stable in long- and short-term storage conditions to ensure reliable analysis. Whereas the stability of anti-vaccine antibodies has been well-studied, there are few reports examining the stability of anti-therapeutic antibodies using clinical samples. In this study, ADA samples from four clinical trials of antibody therapeutics were found to be stable after long-term storage (1-10 years) at -80°C and short-term storage (24 h to two weeks) at 4°C, 22°C, and 37°C. In addition, samples were stable after 16 freeze/thaw cycles. The results demonstrate the stability of ADA in clinical samples under various conditions. Consequently, the results observed herein suggest that the routine assessment of ADA sample stability may not be warranted.
生物治疗药物有可能引起不必要的免疫反应，导致产生抗药性抗体（ADA）。对 ADA 反应进行检测、定性和监测对于了解药物的安全性和有效性至关重要。ADA 样品必须在长期和短期储存条件下保持稳定，以确保分析的可靠性。虽然抗疫苗抗体的稳定性已经得到了很好的研究，但使用临床样本研究抗治疗抗体稳定性的报道却很少。本研究发现，来自四项抗体治疗临床试验的 ADA 样品在-80°C 长期储存（1-10 年）和 4°C、22°C 和 37°C 短期储存（24 小时至两周）后均保持稳定。此外，样品在经过 16 次冷冻/解冻循环后也很稳定。结果表明，在各种条件下，临床样本中的 ADA 都很稳定。因此，本文观察到的结果表明，可能不需要对 ADA 样品的稳定性进行常规评估。
期刊介绍：
The AAPS Journal, an official journal of the American Association of Pharmaceutical Scientists (AAPS), publishes novel and significant findings in the various areas of pharmaceutical sciences impacting human and veterinary therapeutics, including:
· Drug Design and Discovery
· Pharmaceutical Biotechnology
· Biopharmaceutics, Formulation, and Drug Delivery
· Metabolism and Transport
· Pharmacokinetics, Pharmacodynamics, and Pharmacometrics
· Translational Research
· Clinical Evaluations and Therapeutic Outcomes
· Regulatory Science
We invite submissions under the following article types:
· Original Research Articles
· Reviews and Mini-reviews
· White Papers, Commentaries, and Editorials
· Meeting Reports
· Brief/Technical Reports and Rapid Communications
· Regulatory Notes
· Tutorials
· Protocols in the Pharmaceutical Sciences
In addition, The AAPS Journal publishes themes, organized by guest editors, which are focused on particular areas of current interest to our field.
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