Commercialization of Human Mammary Basal / Luminal Cell System for Research

描述(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19万名女性被诊断出患有乳腺癌，其中4万人将死亡。大多数乳腺癌起源于产奶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：被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先兆。因此，独立研究这些细胞群体以及在共培养模型系统中研究这些细胞群体是很重要的。没有商业来源的质量受控的、匹配的基底细胞和腔细胞(来自个人捐赠者)，迫使研究人员自己分离和鉴定这些细胞。这一过程非常耗时，需要接触到人体组织，并在细胞的制备和表征方面引入了差异。原代培养的人乳腺来源细胞是目前用于研究人类乳腺癌发生和理解的理想模型。由于没有始终如一的商业来源的原代培养的人类乳房来源的腔细胞和基底细胞，Zen-Bio公司将通过向研究界提供一种具有良好特性的系统来满足这一需求。该项目的第一阶段专注于从非病变组织中产生优化的原代人类乳房来源的基底/腔细胞系统。成功地分离和培养了正常人乳腺基底和管腔上皮细胞。在第一阶段成功完成的基础上，我们渴望通过专注于使这一细胞系统商业化来扩大我们在第二阶段的研究。此外，我们将扩大细胞系统，包括来自乳腺肿瘤组织的基底和腔上皮细胞。这个项目的目标1是继续详细描述正常的基底细胞和腔细胞，重点是质量控制和商业化的释放标准。目标2是在我们现有能力的基础上，建立人乳腺癌肿瘤来源细胞的分离和繁殖程序，并详细描述其特征。目标3是对正常和恶性人类细胞进行比较分析，为Zen-Bio的商业化和额外的合同化验服务建立质量控制标准。该提案预计将提供多种产品：来自非疾病和恶性组织的匹配的原代人类乳腺细胞系统、支持介质和试剂、合同分析服务以及用于乳腺癌研究的试剂盒。 公共卫生相关性：在该项目完成后，研究人员将可从商业上获得从正常和恶性乳腺组织中提取的完全特征化的人类原代乳腺来源的基底/腔细胞系统。这些系统将提供一个目前无法获得的机会来调查乳腺癌的病因和确定潜在的治疗方法。

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.