Cell Therapies Core

项目摘要 细胞疗法核心 细胞治疗核心（CTC）使研究，开发和制造人类细胞用于 接受基于细胞的癌症免疫疗法的患者。CTC生产支持以下功能的电池产品 新的，制药商发起的临床试验（IIT），同时保持符合食品安全局制定的标准 和药物管理局，细胞疗法认证基金会，以及其他认证机构 尸体CTC在临床试验开发和执行的所有阶段为成员提供支持，包括 协同工作，使研究性新药申报、开发和生产验证成为可能 临床放行的工艺和质量控制测定，以及 临床试验中的患者。CTC还帮助会员起草和提交与细胞治疗相关的赠款， 合同.反恐委员会通过将其活动分为四个具体目标来支持成员： 目标1：开发用于细胞疗法翻译的新技术。 目的2：提供监管援助，支持细胞疗法。 目标3：为免疫治疗临床试验生产最高质量的细胞产品。 目标4：教育和培训致力于细胞疗法事业的科学家和临床医生。 CTC通过提供树突状细胞和免疫抑制剂，为FDA批准的IIT的高影响力研究做出了重大贡献。 基于肿瘤细胞的疫苗，基因修饰的干细胞和祖细胞，T调节细胞，自然杀伤细胞， 肿瘤浸润淋巴细胞（TIL）和嵌合抗原受体（CAR）T细胞。自2016年以来，CTC成员 使用量增加了63%。具体而言，反恐委员会支持了三个领域的26个成员国（67%经过同行审查）， CCSG计划（MM 24%，HOB 3%，IO 73%），支持53种协议（自2008年以来增加了96%）。 2016）和450个蜂窝产品的制造。这些活动占所有活动的97%。 上一个报告所述期间四氯化碳的使用情况。反恐委员会的专门知识与其充分支持 评价细胞的离体选择和扩增，转基因表达，干细胞工程， 以及增强免疫力和/或有效治疗实体癌和血液癌的遗传策略。到 为了最大限度地提高反恐委员会的能力，以满足未来五年预计的成员国需求，反恐委员会正在扩大其 物理占地面积，增加8，300平方英尺的空间，使CTC能够提供自动化的封闭系统 在100，000级空间中制造蜂窝产品，并提高其制造能力， 目前有10,000个实验室空间。此外，反恐委员会还将扩大其独特服务的范围， 包括产生开发基于细胞的疗法所必需的病毒载体，如CAR-T 和基于TIL的疗法，减少关键的发展瓶颈并满足会员需求。

PROJECT SUMMARY CELL THERAPIES CORE The Cell Therapies Core (CTC) enables research, development and manufacturing of human cells for use in patients undergoing cell-based immunotherapies for cancer. CTC manufactures cell products that support novel, investigator-initiated clinical trials (IITs), while maintaining compliance with standards set by the Food and Drug Administration, the Foundation for the Accreditation of Cellular Therapies, and by other accrediting bodies. CTC supports Members in all stages of clinical trial development, and execution, including collaborative work enabling investigational new drug filing, development and validation of manufacturing processes, and quality control assays for clinical release, as well as full scale clinical manufacturing for patients on clinical trials. CTC also aids Members in drafting and submitting cell therapy-related grants or contracts. CTC supports Members by organizing its activities into four Specific Aims: Aim 1: To develop new technologies for translation of cellular therapies. Aim 2: To provide regulatory assistance in support of cellular therapies. Aim 3: To produce the highest quality cellular products for immunotherapy clinical trials. Aim 4: To educate and train scientists and clinicians committed to careers in cellular therapies. CTC has significantly contributed to high impact research of FDA-approved IITs by providing dendritic cell and tumor cell-based vaccines, gene-modified stem and progenitor cells, T regulatory cells, natural killer cells, tumor-infiltrating lymphocytes (TIL), and chimeric antigen receptor (CAR) T cells. Since 2016, CTC Member usage has increased by 63%. Specifically, CTC has supported 26 Members (67% peer reviewed) across three CCSG Programs (MM 24%, HOB 3%, IO 73%), resulting in support of 53 protocols (a 96% increase since 2016) and the manufacture of 450 cellular products. Together, this Member activity represented 97% of all CTC usage over the last reporting period. The expertise of CTC is consistent with its mission to fully support clinical trials evaluating ex vivo selection and expansion of cells, transgene expression, stem cell engineering, and genetic strategies that augment immunity and/or effectively treat solid and hematologic cancers. To maximize CTC’s capacity to meet projected Member needs over the next five years, CTC is expanding its physical footprint, adding 8,300-ft2 of space that will enable CTC to provide automated, closed-system manufacturing of cellular products in a class 100,000 space, and to increase manufacturing capacity in its current class 10,000 laboratory spaces. Furthermore, CTC will expand its repertoire of unique services to also include the generation of viral vectors necessary for the development of cell-based therapies, such as CAR-T and TIL based therapies, reducing a critical developmental bottleneck and meeting Member needs.