Automated wire harness manufacture; Eliminate traditional wiring, saving space and weight. Simplify supply chains and manufacturing.

2020年4月14日 · The document provides broad guidance on appropriate standards for the derivation and characterization of cell substrates used in the production of biotechnological/biological products and...

1998年3月31日 · This document provides guidance on standards for the derivation of human and animal cell lines and microbial cells to be used in biotechnological/biological products. It outlines recommendation for the preparation and characterisation of cell banks to be used for production.

本指导原则的目的是对用于生产生物技术产品及生物制品的人和动物细胞系、微生物细胞系及其细胞库的制备和鉴定建立合适的标准提供指导意见。 本文件还为申请产品上市时在这些方面应申报哪些资料提出了建议。 历史上，由于细胞源性的生物制品存在外来污染或出于对用于制备产品的细胞特性的担忧，引发了一些对产品质量的关切。 重组DNA (rDNA)制品的质量也与细胞基质中构建的表达载体有关。 由此，业界达成共识，认为细胞基质的特性以及与之相关的事件将影响产品 …

Engineering automated manufacturing systems that enable electrical function to be integrated. We are committed to making electrical function as integral to products as mechanical function or physical form.

Q5D 用于生物技术产品及生物制品生产的细胞基质的来源和鉴定（中文翻译公开征求意见稿）.pdf 附件 26 ： Q5D 英文原文.pdf

2025年3月14日 · UK-based robotics firm Q5D Technology has secured $2.5 million in seed funding to finance the development of a new multifunctional wiring and electronics 3D printer.

Q5D is changing this by combining robotics and AI to add wiring and printed electronics directly into products, thus automating what is currently a manual process. Their technology yields reduced manufacturing cost, and at the same time improved quality and function.

Our robotic manufacturing cells replace manual assembly processes by applying wires and connectors directly to the product, sub-assembly or component. A range of deposition techniques can be deployed to add electrical functionality using interchangeable end effectors. These tools deliver: The CY1000 is a self-contained manufacturing cell:

2021年2月25日 · 为进一步推进ICH三级指导原则的实施，我中心在充分征求工业界意见的基础上，研究制定了ICH《Q5D：用于生物技术产品及生物制品生产的细胞基质的来源和鉴定》《M9：基于生物药剂学分类系统的生物等效性豁免》及《M9问答》实施建议，具体为“申请人需在现行技术要求基础上，尽早按照ICH指导原则的要求开展研究； 本公告发布之日起6个月后开始的相关研究（以试验记录时间点为准），适用上述ICH指导原则”，现公开征求意见。 请将相关意见 …