GMP Manufacturing

摘要共享资源05：GMP制造(GMP-SR) 希望之城(COH)的GMP制造共享资源(GMP-SR)同时提供生物和化学 GMP制造能力，允许快速且经济高效地将新型治疗剂转化为 临床试验。总而言之，生物和化学GMP设施是COH独有的，并使其与众不同 作为全国首屈一指的癌症机构之一，翻译由COH开发的创新疗法 调查人员在过去十年中。 GMP-SR的具体目标： 目的1.病毒载体的生产。 目的2.制备自体CAR T细胞产品、CD34+HSPC基因治疗、TIL细胞产品。 目的3.生产用于第一阶段临床试验的同种异体细胞治疗产品。 目的4.小分子治疗剂的制备。 GMP-SR由两个生物设施组成，生物医学和遗传学中心(CBG)，细胞疗法 生产中心(CTPC)和化学GMP合成设施(CGSF)。这些资源提供了流程 发展、项目管理支助、预算编制、监管战略、质量控制和质量保证， 和cGMP兼容的临床级免疫效应细胞产品，以干细胞为基础的再生 药品、单抗、慢病毒、逆转录病毒、痘病毒、单纯疱疹病毒和腺病毒 载体、疫苗以及从低分子量靶向分子的小分子制剂 用于复杂合成生物聚合物的试剂(MW&lt；1000)，如基于RNA的寡核苷酸疗法和 成像剂。 CBG和CTPC是完全符合cGMP的临床前和1/2期中试生产设施。此外 由于具有多产品能力，CBG是美国首屈一指的多过程学术设施，能够 同时生产符合cGMP的临床级产品，用于临床前研究和早期临床 审判。这两个生物设施支持第一阶段病毒载体和修饰细胞产品的生产 临床试验。目前，COH研究人员制造CAR T细胞、CAR Treg细胞、NK细胞、树突状细胞、 CD34+造血干/祖细胞和胰岛细胞。CGSF制造小分子和大分子 治疗学，包括药物和生物聚合物。 2017-21年度按收入百分比划分的成员利用率：总计98.6(1.5 MCBC、5.8 DCT、54 CI、37.3 HM、0 CCPS) 成员出版物：8，4，带影响因子&gt；10 支持资助金：共6笔(3笔CIRM，3笔NCI(2R01))

Abstract Shared Resource 05: GMP Manufacturing (GMP-SR) The GMP Manufacturing Shared Resource (GMP-SR) at City of Hope (COH) offers both biological and chemical GMP manufacturing capabilities allowing for rapid and cost-effective translation of novel therapeutic agents to clinical trials. Together, the biological and chemical GMP facilities are unique to COH and have distinguished it as one of the premier cancer institutions in the nation for translating innovative therapies developed by COH investigators over the past decade. Specific Aims for GMP-SR: Aim 1. Production of viral vectors. Aim 2. Production of autologous CAR T cell products, CD34+ HSPC gene therapy, and TIL cell products. Aim 3. Production of allogeneic cell therapy products for Phase 1 clinical trials. Aim 4. Manufacturing of small molecule therapeutics. The GMP-SR consists of two biological facilities, the Center for Biomedicine & Genetics (CBG), the Cell Therapy Production Center (CTPC), and a Chemical GMP Synthesis Facility (CGSF). These resources provide process development, project management support, budgeting, regulatory strategy, quality control and quality assurance, and cGMP-compliant clinical-grade production of immune effector cell products, stem cell-based regenerative medicine products, monoclonal antibodies, lentivirus, retrovirus, poxvirus, herpes simplex virus, and adenovirus vectors, vaccines, as well as small molecule agents ranging from low molecular weight molecularly targeted agents (mw <1000) to complex synthetic biopolymers such as RNA-based oligonucleotide therapeutics and imaging agents. The CBG and CTPC are fully cGMP-compliant preclinical and Phase 1/2 pilot manufacturing facilities. In addition to being multi-product capable, CBG is the nation’s pre-eminent multi-process academic facility capable of simultaneously producing cGMP-compliant clinical-grade products for preclinical studies and early-stage clinical trials. These two biological facilities support production of viral vectors and modified cell products in Phase 1 clinical trials. Currently, COH investigators manufacture CAR T cells, CAR Treg cells, NK cells, dendritic cells, CD34+ hematopoietic stem/progenitor cells, and islet cells. The CGSF manufactures small and large molecule therapeutics including drugs and biopolymers. Members Utilization by %Revenue 2017–21: 98.6 Total (1.5 MCBC, 5.8 DCT, 54 CI, 37.3 HM, 0 CCPS) Publications by Members: 8, 4 with Impact Factor >10 Grants Supported: 6 Total (3 CIRM, 3NCI (2R01))