Efficient Distribution of Human Embryonic Stem Cells

描述(由申请人提供)：Bresagen，Inc.已经培育出四个人类胚胎干细胞(HESC)系，可用于美国国立卫生研究院(NIH)资助的研究项目。为了向研究界提供这一宝贵的资源，Bresagen已将这些细胞授权给Cellsaurus，Inc.。Bresagen还将向Cellsaurus提供技术支持，以实现hESCs和技术的高效转移。Cellsaurus将生产和分销hESC生产线，并将开发和记录将提供给客户的方法和标准操作程序。本申请中提出的工作有三个具体目标。在目标1：HESCs将使用Bresagen已经制定的方法、方案和质量控制标准来生产和分发。电池的生产和销售将遵循GLP规范。目标2：的实验将开发高效扩增细胞的新方法，并将开发用于hESC质量控制的新标记。目标3：重点是制定机制，确保Cellsaurus客户的成功。这一目标包括开发一个有效的hesc分配系统，创建一本技术手册和一个技术支持网站，以及建立一个动手培训讲习班。Cellsaurus将通过从客户那里收回成本以及与获取知识产权相关的使用费流成为一个独立的实体。

DESCRIPTION (PROVIDED BY APPLICANT): BresaGen, Inc has generated four human embryonic stem cell (hESC) lines that can be used for National Institutes of Health (NIH) funded research projects. To make this valuable resource available to the research community, BresaGen has licensed these cells to Cellsaurus, Inc. BresaGen will also provide technical support to Cellsaurus to enable the efficient transfer of hESCs and technologies. Cellsaurus will produce and distribute the hESC lines, and will develop and document methods and standard operating procedures that will be made available to the customers. The work proposed in this application has three Specific Aims. In Aim 1: hESCs will be produced and distributed using the methods, protocols and quality control criteria already developed by BresaGen. Cell production and distribution will adhere to GLP specifications. The experiments of Aim 2: will develop novel methods for the efficient expansion of the cells and will develop new markers to be used in hESC quality control. Aim 3: is focused on the development of mechanisms to ensure the success of Cellsaurus customers. This Aim includes the development of an efficient hESC distribution system, the creation of a technical manual and a technical support website, and the establishment of a hands-on training workshop. Cellsaurus will become an independent entity through recovery of costs from customers, arid by the royalty stream associated with the capture of intellectual property rights.