Product Development and Manufacturing (PDM) Core

引言：转化研究的挑战将影响许多病毒，细菌和 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 将一个潜在的产品投入临床试验核心B、产品开发和 制造（RDM）的核心，是通过提供开发和 生产足够用于I期和II期临床试验的疫苗、诊断和治疗产品。具体 RDM核心的目标包括：（1）协调和优先考虑从研究平台到 转化开发小组委员会（TDS）的临床试验，（2）提供良好实验室规范 (GLP)RCE和非RCE项目产生的产品的临床前开发 研究人员，包括那些需要生物安全3级遏制，（3）优化和验证 生产工艺、设备和控制分析，（4）根据现行良好 临床前和早期临床研究的生产规范（cGMP），以及（5）发展职业生涯 为高级学员提供RCE轮换的机会。产品翻译的研究设计会有所不同 根据研究者和TDS提供的指导，核心 工作人员应具有培养、分离、纯化、分析和克隆方面的经验， 产品从研究组到核心组的平稳过渡。成功完成产品后 开发，临床级材料将根据cGMP在位于的现有中试工厂生产， CSU主校区的微生物学大楼，或区域生物防护实验室（RBL）， 在CSU Foothills校区建造。完整性、稳定性、无菌性、效价的质量控制检测， 根据联邦法规第21条的要求， QC单位。RDM核心基础架构将在RCE中提供一种媒介， 研究到应用研究。使用人类受试者来评价这些药物的安全性和有效性， 早期临床试验中的产品将按照研究者的概述进行，并获得监管机构的批准。 当局 项目相互作用：PDM核心（核心B）将与RCE孢子、孔隙、 和其他核心通过TDS的组织结构。与研究者的其他互动 在RCE之外（无论是校内还是校外，非营利性或营利性）可能会发生，对服务收费 直到RCE研究产品准备好转移到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.