Sana Biotechnology, 300 Tech Square, Suite 700, Cambridge, MA, 02139, USA.
PRA Health Sciences, Raleigh, North Carolina, USA.
AAPS J. 2021 Mar 1;23(2):34. doi: 10.1208/s12248-021-00567-z.
In May 2020, the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) published a recommendation report entitled "Recommendation on nonanimal-derived antibodies". In this report, the EURL ECVAM specifically states: "Therefore, taking into consideration the ESAC Opinion on the scientific validity of replacements for animal-derived antibodies, EURL ECVAM recommends that animals should no longer be used for the development and production of antibodies for research, regulatory, diagnostic and therapeutic applications. The provisions of Directive 2010/63/EU should be respected, and EU countries should no longer authorise the development and production of antibodies through animal immunisation, where robust, legitimate scientific justification is lacking." (1). Here, we are providing the American Association of Pharmaceutical Scientists (AAPS) opinion on the EURL ECVAM recommendation report. In brief, there has been a clear and strong progress in reduction of animal use in the drug discovery and development process, including significant reduction of animal use in production of antibody reagents. Yet, it is proposed that more data need to be generated, shared and discussed within the scientific community before a decision to implement the change to non-animal derived antibodies is made.
2020 年 5 月，欧盟替代动物试验的参考实验室（EURL ECVAM）发布了一份题为“非动物源性抗体替代物建议”的推荐报告。在该报告中，EURL ECVAM 特别指出：“因此，考虑到关于动物源性抗体替代物的科学有效性的 ESAC 意见，EURL ECVAM 建议不再将动物用于研究、监管、诊断和治疗应用中抗体的开发和生产。应遵守 2010/63/EU 指令的规定，欧盟国家应不再授权通过动物免疫来开发和生产抗体，除非缺乏强有力的、合理的科学依据。”（1）。在这里，我们提供了美国制药科学家协会（AAPS）对 EURL ECVAM 推荐报告的意见。简而言之，在药物发现和开发过程中减少动物使用方面已经取得了明显和强劲的进展，包括在生产抗体试剂方面大大减少了动物使用。然而，有人提议，在做出采用非动物源性抗体的决定之前，需要在科学界生成、共享和讨论更多的数据。
