GMP Manufacturing Core

GMP生产核心共享资源 摘要 City of Hope的GMP生产核心设施提供生物和化学GMP生产 能力的生物设施包括生物制剂和细胞GMP生产中心，包括 生物医学和遗传学中心（CBG）和细胞治疗生产中心（CTPC）。化学 GMP合成设施（CGSF）是一个独立的操作，提供最先进的生物聚合物和小 分子制造COH是美国唯一提供生物和化学GMP的癌症中心 在一个机构生产。这些设施提供工艺开发、监管支持， 符合cGMP的临床级CAR T细胞产品生产，基于干细胞的再生医学 产品、单克隆抗体、慢病毒载体、疫苗和复杂分子，包括生物聚合物 （肽、siRNA-适体、DNA-肽杂合体）、纳米材料和天然产物。 CBG于2000年开业，是一个完全符合cGMP的20，000平方英尺的临床前和I/II期试点项目 拥有10，000平方英尺的分类生产空间的制造设施。除了是多产品 能力，它是国家的卓越的多进程的学术设施，能够同时生产 符合cGMP的临床级产品，数量充足，可用于临床前研究和早期临床 审判CBG支持COH研究人员生产病毒载体和修饰细胞产品（CAR T 细胞;基因修饰的CD 34+细胞;基因修饰的神经干细胞），目前正在进行I期临床试验， 适应症包括CD 19+恶性肿瘤、AML、GBM和AIDS相关淋巴瘤。CTPC还 符合cGMP标准，并于2010年开放，以满足对细胞治疗的额外需求。CTPC提供6，800个 平方英尺生产空间，能够同时进行多产品和多工艺制造。的 CGSF（成立于2012年）生产小分子和大分子治疗剂。它还 生产纳米材料，复杂的天然产物和生物聚合物，如肽，siRNA适体，DNA- 肽杂合体。CGSF提供的服务包括：药物发现，工艺研究，开发， 药物原料药（API）的早期临床生产。该设施设计有三个 独立的生产车间生产符合食品和药物管理局要求的API， 在临床前毒理学研究和I/II期临床试验的足够规模（克至千克）上。 GMP生产核心由Joseph Gold博士、大卫霍恩博士和大卫许博士共同指导。超过 在过去的五年里，共有28名独立调查员使用了该核心，其中包括10名CC成员和8名 NCI指定的癌症中心。此外，还生产了553种产品，7种单独的癌症临床 审判得到了核心的支持。

GMP Manufacturing Core Shared Resource ABSTRACT The GMP Manufacturing Core Facility at City of Hope offers both biological and chemical GMP manufacturing capabilities. The biological facilities consist of the Biologics & Cellular GMP Manufacturing Center, comprising the Center for Biomedicine and Genetics (CBG) and the Cell Therapy Production Center (CTPC). The Chemical GMP Synthesis Facility (CGSF) is a stand-alone operation providing state-of-the-art biopolymer and small molecule manufacturing. COH is the only Cancer Center in the US to provide both biological and chemical GMP manufacturing at a single institution. These facilities provide process development, regulatory support, and cGMP-compliant clinical-grade production of CAR T cell products, stem cell-based regenerative medicine products, monoclonal antibodies, lentiviral vectors, vaccines, and complex molecules including, biopolymers (peptides, siRNA-aptamers, DNA-peptide hybrids), nanomaterials, and natural products. Opened in 2000, the CBG is a fully cGMP-compliant 20,000 square foot preclinical and Phase I/II pilot manufacturing facility with 10,000 square feet of classified production space. In addition to being multi-product capable, it is the nation’s pre-eminent multi-process academic facility capable of simultaneously producing cGMP-compliant clinical-grade products in sufficient quantities for preclinical studies and early stage clinical trials. The CBG supports COH investigators in the production of viral vectors and modified cell products (CAR T cells; gene-modified CD34+ cells; gene-modified neural stem cells) that are currently in Phase I clinical trials for indications including CD19+ malignancies, AML, GBM, and AIDs-related lymphoma. The CTPC is also cGMP-compliant and opened in 2010 to meet additional demand for cell therapeutics. The CTPC provides 6,800 sq. ft. of production space and is capable of simultaneous multi-product and multi-process manufacturing. The state-of-the-art CGSF (established in 2012) manufactures small and large molecule therapeutics. It also produces nanomaterials, complex natural products, and biopolymers, such as peptides, siRNA-aptamers, DNA- peptide hybrids. The CGSF provides services including: drug discovery, process research, development, and early clinical manufacturing of pharmaceutical drug substances (APIs). The facility is designed with three independent manufacturing suites to produce API that meets Food and Drug Administration requirements and on sufficient scales (gram to kilogram) for preclinical toxicology studies and Phase I/II clinical trials. The GMP Manufacturing Core is co-directed by Joseph Gold, PhD, David Horne, PhD, and Dr. David Hsu. Over the past five years, the Core was used by a total of 28 unique investigators, including ten CC members and eight NCI-designated Cancer Centers. In addition, 553 products were manufactured and 7 separate cancer clinical trials were supported by the Core.