Product Development and Manufacturing (PDM) Core

简介：翻译研究中的挑战将影响许多病毒、细菌学和 区域卓越中心(RCE)内的蛋白质组学/基因组学研究人员，他们致力于 将一种潜在的产品投入临床试验。核心B的总体目标是产品开发和 制造(RDM)核心，旨在通过提供开发和 生产足以进行第一阶段和第二阶段临床试验的疫苗、诊断和治疗产品。特定的 RDM核心的目标包括：(1)协调并确定产品翻译的优先顺序，从研究平台到 与翻译发展小组委员会(TDS)进行的临床试验，(2)提供良好的实验室实践 (GLP)来自RCE和非RCE项目的产品的临床前开发 调查人员，包括那些需要生物安全3级控制的人员，(3)优化和验证 制造工艺、设备和控制分析，(4)制造当前良好的产品 临床前和早期临床研究的生产实践(CGMP)，以及，(5)发展职业生涯 高级实习生参加RCE轮换的机会。产品翻译的研究设计将有所不同 产品之间的差异，取决于研究调查员和TDS提供的指导。堆芯 人员将在培养、分离、纯化、分析和克隆方面具有经验，以允许 产品从研究组平稳过渡到核心组。在产品成功完成后 开发，临床级别的材料将根据cGMP在现有的试点工厂生产，位于 CSU主校区的微生物大楼，或区域生物遏制实验室(RBL) 将建在加州大学山脚下的校园里。完整性、稳定性、无菌、效价、 安全性和纯度，如联邦法规代码，第21章所要求，将在相邻的 品管部门。RDM核心基础架构将在RCE内提供一个媒介，用于将产品从基本 从研究到应用研究。使用人体受试者来评估这些药物的安全性和有效性 早期临床试验中的产品将遵循研究人员概述的内容，并获得监管部门的批准 当局。 项目互动：产品数据管理核心(核心B)将与RCE孢子、毛孔、 和其他核心通过全日制发展组的组织结构。与调查人员的其他互动 在RCE之外(校园内或校外、非营利性或营利性)可能会发生，但需支付服务费 基础，直到RCE研究产品准备好移入到pdm核心。

Introduction: Challenges in translational research will affect many viral, bacteriological, and proteomics/genomics investigators within the Regional Center of Excellence (RCE), who are intent on moving a potential product into clinical trials. The overall objective for Core B, Product Development and Manufacturing (RDM) Core, is to address these challenges by providing the capacity to develop and manufacture vaccine, diagnostic, and therapeutic products sufficient for Phase I and II clinical trials. Specific aims for the RDM Core include: (1) coordinate and prioritize product translation from the research bench to clinical trials with the Translational Development Subcommittee (TDS), (2) provide Good Laboratory Practice (GLP) pre-clinical development for products arising from the various projects of RCE and non-RCE investigators, including those which need Biosafety Level 3 containment, (3) optimize and validate the manufacturing process, equipment, and control assays, (4) manufacture products under current Good Manufacturing Practice (cGMP) for pre-clinical and early clinical studies, and, (5) develop career opportunities for senior trainees on RCE rotations. The research design for product translation will vary between products, depending upon direction provided by the research investigator and the TDS. Core personnel will have experience in culturing, fractionating, purifying, analyzing, and cloning to allow for smooth product transition from the research group to the core group. Upon successful completion of product development, clinical grade material will be manufactured under cGMP in the existing pilot plant located in the Microbiology Building on the CSU main campus, or in the Regional Biocontainment Laboratory (RBL) to be constructed at the CSU Foothills campus. Quality control testing for integrity, stability, sterility, potency, safety, and purity, as required by the Code of Federal Regulations, Title 21, will be performed in an adjacent QC unit. The RDM Core infrastructure will provide a medium within the RCE to move a product from basic research to applied research. The use of human subjects to evaluate the safety and efficacy of these products in early clinical trials will follow as outlined by the investigator, and approved by regulatory authorities. Project Interactions: The PDM Core (Core B), will have extensive interactions with RCE Spores, Pores, and other Cores through the organizational structure of the TDS. Additional interactions with investigators outside of the RCE (either on-campus or off-campus, non-profit or for-profit) may occur, on a fee for service basis, until RCE research products are ready to be moved into the PDM Core.