生生物治疗产品的开发:亚太微生物群联盟的立场声明
Ching-Hung Tseng1, Sunny Wong2, Jun Yu3
1Germark Biotechnology, Co, Ltd, Taichung, Taiwan.
Gut
|February 26, 2025
概括
开发活生物治疗产品 (LBPs) 需要优先考虑人类衍生的菌株和严格的临床前和临床评估. 专家的共识强调微生物学评估,临床相关性和整个LBP开发过程中的安全性,以获得成功的结果.
科学领域:
- 微生物组研究的研究.
- 生物治疗学 生物治疗学
- 胃肠病学 胃肠病学
背景情况:
- 活生物治疗产品 (LBPs) 正在引起人们对使用微生物治疗疾病的兴趣,例如Akkermansia muciniphila.
- 目前的发展缺乏全面的指导方针,需要专家的共识.
- 亚太地区专家召开会议,讨论LBP发展的关键问题.
研究的目的:
- 建立专家对开发活生物疗法产品 (LBPs) 关键考虑因素的共识.
- 为LBPs提供关于合理性,临床前研究和临床试验准备的指导.
- 解决在LBP开发中的标准化方法的需求.
主要方法:
- 组建了一个由微生物组研究,微生物学,胃肠病学,内科和生物治疗学专家组成的小组.
- 在2023年亚太微生物群联盟开幕会议期间进行了一场有组织的,反复的圆桌讨论.
- 在围绕LBP开发的关键问题上建立了专家共识.
主要成果:
- 共识主要集中在LBP开发,临床前研究和临床试验准备的理由上.
- 建议包括优先考虑具有明确的临床需求和疗效的人类衍生,食品来源的菌株.
- 基本的临床前评估包括彻底的查,基因型,表型,体外/动物研究,以及强大的细胞储存/遗传监测.
结论:
- 在LBP的开发中,需要对微生物学评估,临床相关性,科学机制和安全性给予高度重视.
- 在LBP开发的各个阶段,严格的科学和安全措施至关重要.
- 这些全面的方法确保了LBP的安全性,有效性和长期成功.
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