Commercialization of Human Mammary Basal / Luminal Cell System for Research

描述（由申请人提供）：乳腺癌是女性中第二常见的癌症。2009年，美国将有大约19万名妇女被诊断出患有乳腺癌，4万人将死亡。大多数乳腺癌起源于产乳腺的小叶或导管细胞。在这些结构中，有两种主要的细胞类型：由基底肌上皮包围的内腔细胞。这些细胞类型是不同的，是各种形式乳腺癌的前体。因此，重要的是独立地以及在共培养模型系统中研究这些细胞群体。没有商业来源的质量控制，匹配的基底细胞和管腔细胞（来自个体供体），迫使研究人员自己分离和表征细胞。这个过程是耗时的，需要接近人体组织，并在细胞的制备和表征中引入变化。原代培养的人乳腺源性细胞是目前用于研究人类乳腺癌的发生和理解的理想模型。由于原代培养的人乳房来源的管腔和基底细胞的一致商业来源不可用，Zen-Bio，Inc.将通过为研究团体提供一个具有良好特征的系统来满足这一需求。 该项目的I期重点是从非病变组织中生成优化的原代人乳腺源性基底/管腔细胞系统。实现了正常人基底和腔乳腺上皮细胞的分离和增殖。在第一阶段成功完成的基础上，我们渴望通过专注于使这种细胞系统商业化来扩展我们在第二阶段的研究。此外，我们将扩大细胞系统，包括乳腺肿瘤组织的基底和腔乳腺上皮细胞。本项目的目的1是继续对正常基底细胞和管腔细胞进行详细表征，重点关注商业化的质量控制和放行标准。目的2是建立人乳腺癌肿瘤源细胞的分离和增殖程序和详细的表征建立在我们现有的能力。目的3是在正常和恶性人类细胞之间进行比较分析，以建立Zen-Bio商业化和额外合同检测服务的质量控制标准。预计该提案将提供多种产品：来自非病变和恶性组织的匹配的原代人类乳腺细胞系统、支持培养基和试剂、合同测定服务以及乳腺癌研究试剂盒。 公共卫生相关性：在这个项目完成后，一个充分表征的人原代乳腺来源的基底/腔细胞系统，从正常和恶性乳腺组织将商业上提供给研究人员。这些系统将提供一个目前尚不具备的机会，以调查乳腺癌的病因，并确定潜在的治疗。

DESCRIPTION (provided by applicant): Breast cancer is the second most common cancer among women. Roughly 190,000 women in the U.S. will be diagnosed with breast cancer in 2009, and 40,000 will die. The majority of breast cancers originate in the lobular or ductal cells of the milk-producing glands. In these structures, there are two main cell types: the inner luminal cells surrounded by basal myoepithelium. These cells types are distinct and are the precursors to various forms of breast cancer. As such, it is it is important to study these cell populations independently as well as in co-culture models systems. There are no commercial sources of quality-controlled, matched basal and luminal cells (from individual donors), forcing researchers to isolate and characterize the cells on their own. This process is time-consuming, requires access to human tissue, and introduces variation in the preparation and characterization of the cells. Primary cultured human mammary-derived cells are an ideal model currently used to investigate the genesis and understanding of human breast cancer. Because a consistent commercial source of primary human cultured breast-derived luminal and basal cells is unavailable, Zen-Bio, Inc. will address this need by providing a well characterized system to the research community. Phase I of this project focused on generating an optimized primary human mammary-derived basal/luminal cell system from non-diseased tissue. Isolation and propagation of normal human basal and luminal mammary epithelial cells was achieved. Based on the successful completion of Phase I, we are eager to extend our research in Phase II by focusing on making this cell system commercially available. Additionally, we will expand the cell system to include basal and luminal mammary epithelial cells from breast tumor tissue. Aim 1 of this project is to continue detailed characterization of normal basal and luminal cells focusing on quality control and release criteria for commercialization. Aim 2 is to establish isolation and propagation procedures and detailed characterization of human breast cancer tumor derived cells building on our existing capabilities. Aim 3 is to perform comparative analyses between normal and malignant human cells to establish quality control criteria for commercialization and additional contract assay services at Zen-Bio. Multiple product offerings are expected from this proposal: matched, primary human mammary cell systems from non- diseased and malignant tissue, support media and reagents, contract assay services, and kits for breast cancer research. PUBLIC HEALTH RELEVANCE: At the completion of this project, a fully characterized human primary mammary-derived basal/luminal cell system from normal and malignant breast tissue will be commercially available to researchers. These systems will provide a currently unavailable opportunity to investigate the etiology of breast cancer and to identify potential cures.