《组织工程医疗产品生物制造的测量需求研讨会报告》

  • 来源专题:计量基标准与精密测量
  • 发布时间:2024-04-30
  • 生物制造的组织工程构建体有可能改变个性化医疗。然而,在制造后和整个临床前使用过程中对这些构建体进行表征仍然具有挑战性。2022年12月1日,美国国家标准与技术研究院(NIST)举办了为期一天的研讨会,讨论含有细胞的生物制造构建体的测量需求,重点是构建体结构的计量、构建体中的细胞活力和构建体的功能能力。组织工程医疗产品生物制造的测量需求研讨会旨在实现未来的研究方向、标准开发以及将这些结构用于临床。虚拟研讨会召集了180多名与会者,代表学术界、政府和工业部门。与会者重点讨论和确定了表征临床应用生物制造、组织工程医疗产品(TEMP)的测量需求。研讨会指出,生物制造领域正处于以破坏性劳动密集型方法为特征的初级阶段。对无损、准确的生存能力和功能表征的一致呼吁凸显了创新的关键需求。同时,对标准化测试、参数和参考材料的需求越来越大,再加上不同电池类型和整体制造工艺的特定应用标准。提倡建立合作联盟,以促进知识共享和技术的有效整合。已确定的一致性和可重复性方面的挑战强调了生物制造中对再现性、稳健的测量技术和跨学科合作的迫切需求。此外,捕捉各种测量的系统的关键作用、对微创传感器的偏好以及实验室用临床技术小型化的努力共同推动了该领域朝着渐进和多维的组织表征方法发展。一致支持参考数据的收集、验证和标准化,并提议建立一个中央数据门户,这意味着共同努力提高该领域关键信息的可靠性和可访问性。
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