GMP Manufacturing

GMP制造

• 批准号: 10628589
• 负责人: DAVID A. HORNE
• 金额: $ 14.4万
• 依托单位: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-08-01 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10628589
• 关键词: AIDS-Related Lymphoma; Adenovirus Vector; Advisory Committees; Allogenic; Autologous; Biological; Biopolymers; Biotechnology; Budgets; CAR T cell therapy; CD34 gene; Cancer Center; Cancer Center Support Grant; Cancer Patient; Cell Culture Techniques; Cell Therapy; Cells; Chemicals; Cities; Clinical; Clinical Trials; Collaborations; Colorectal Cancer; Complex; Conduct Clinical Trials; Cyclic GMP; Dendritic Cells; Development; Dose; Effector Cell; Engineering; Genetic; Goals; Grant; Hematopoietic stem cells; Immune; Infusion procedures; Innovative Therapy; Institution; Islet Cell; Lentivirus; Lentivirus Vector; Licensing; Malignant Neoplasms; Malignant neoplasm of lung; Mesenchymal Stem Cells; Methodology; Methods; Mission; Modality; Molecular; Molecular Target; Molecular Weight; Monoclonal Antibodies; NK cell therapy; Natural Killer Cells; Non-Hodgkin' s Lymphoma; Oligonucleotides; Oncolytic viruses; Pharmaceutical Preparations; Phase; Phase I Clinical Trials; Poxviridae; Preparation; Process; Production; Proliferating Cell Nuclear Antigen; Protocols documentation; Publications; Quality Control; RNA; Regenerative Medicine; Regulatory T-Lymphocyte; Research Personnel; Resource Sharing; Resources; Retroviral Vector; Retroviridae; STAT3 gene; Services; Side; Simplexvirus; Small Interfering RNA; Solid Neoplasm; Suspension Culture; Suspensions; Testing; Therapeutic; Therapeutic Agents; Translating; Translations; Tumor-Infiltrating Lymphocytes; United States National Institutes of Health; Vaccines; Viral Vaccines; Viral Vector; Virus; chimeric antigen receptor T cells; clinical center; cost effective; experimental study; first-in-human; gene therapy; imaging agent; induced pluripotent stem cell; inhibitor; innovation; lymphocyte product; manufacture; manufacturing capabilities; manufacturing facility; manufacturing process; manufacturing scale-up; manufacturing systems; manufacturing technology; melanoma; member; nerve stem cell; novel therapeutics; oncology trial; phase I trial; poxvirus vectors; pre-clinical; preclinical study; programmed cell death ligand 1; programs; quality assurance; small molecule; small molecule inhibitor; small molecule therapeutics; stem cells; targeted agent; therapy development

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))

摘要共享资源 05：GMP 制造 (GMP-SR) City of Hope (COH) 的 GMP 制造共享资源 (GMP-SR) 提供生物和化学产品 GMP 制造能力允许快速且经济有效地将新型治疗剂转化为 临床试验。生物和化学 GMP 设施是 COH 所独有的，并使其与众不同 作为全国首屈一指的癌症机构之一，致力于转化 COH 开发的创新疗法 过去十年的调查人员。 GMP-SR 的具体目标： 目标1.病毒载体的生产。 目标2.生产自体CAR T细胞产品、CD34+ HSPC基因治疗和TIL细胞产品。 目标 3. 生产用于 1 期临床试验的同种异体细胞治疗产品。 目标 4. 小分子治疗药物的制造。 GMP-SR 由两个生物设施组成：生物医学和遗传学中心 (CBG)、细胞治疗中心 生产中心 (CTPC) 和化学 GMP 合成设施 (CGSF)。这些资源提供了流程 开发、项目管理支持、预算、监管策略、质量控制和质量保证、 和符合 cGMP 的临床级免疫效应细胞产品生产、基于干细胞的再生 医药产品、单克隆抗体、慢病毒、逆转录病毒、痘病毒、单纯疱疹病毒和腺病毒 载体、疫苗以及小分子制剂，包括低分子量分子靶向制剂 试剂（分子量 <1000）用于复杂的合成生物聚合物，例如基于 RNA 的寡核苷酸治疗剂和 显像剂。 CBG 和 CTPC 是完全符合 cGMP 的临床前和 1/2 期试验生产设施。此外 凭借多产品能力，CBG 是美国卓越的多流程学术机构，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 试验。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研究人员生产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 生产小分子和大分子 治疗方法包括药物和生物聚合物。 2017-21 年会员使用率（按收入百分比）：总计 98.6（1.5 MCBC、5.8 DCT、54 CI、37.3 HM、0 CCPS） 会员发表论文：8篇、4篇，影响因子>10 支持的赠款：总计 6 项（3 CIRM、3NCI (2R01)）