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，美国大约有19万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乳腺的小叶细胞或导管细胞。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。这些细胞类型不同，是各种乳腺癌的前体。因此，独立研究这些细胞群以及在共培养模型系统中是很重要的。没有商业来源的质量控制，匹配的基底细胞和腔细胞（来自个人供体），迫使研究人员自己分离和表征细胞。这个过程耗时，需要接触人体组织，并且在细胞的制备和表征中引入了变化。原代培养的人乳腺源性细胞是目前用于研究人类乳腺癌发生和了解的理想模型。由于没有一致的人类培养乳腺源性管腔细胞和基底细胞的商业来源，Zen-Bio公司将通过向研究界提供一个特性良好的系统来满足这一需求。该项目的第一阶段侧重于从非病变组织中生成优化的原代人乳腺源性基底/腔细胞系统。实现了正常人乳腺基底和腔上皮细胞的分离和增殖。基于第一阶段的成功完成，我们渴望通过将该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，包括来自乳腺肿瘤组织的基底和腔乳腺上皮细胞。该项目的目标1是继续详细表征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类乳腺癌肿瘤来源细胞的分离和繁殖程序和详细特征。目标3是在正常和恶性人类细胞之间进行比较分析，以建立商业化的质量控制标准和Zen-Bio的额外合同分析服务。该提案预计将提供多种产品：来自非病变和恶性组织的匹配的原代人乳腺细胞系统，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。

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.