Radiolabeling, Quality Control, and Immunoassays

放射性标记、质量控制和免疫测定

• 批准号: 7728852
• 负责人: HABIBE KARACAY
• 金额: $ 12.78万
• 依托单位: CTR FOR MOLECULAR MEDICINE/IMMUNOLOGY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7728852
• 关键词: 90Y; Antibodies; Biological Assay; Blood; Clinical Trials; Core Facility; Count; Data; Dose; Drug Kinetics; Ensure; Equipment; Equipment and supply inventories; Exclusion; Extramural Activities; Hand; High Pressure Liquid Chromatography; Immunoassay; Isotope Labeling; Isotopes; Label; Laboratories; Maintenance; Methods; New Jersey; Numbers; Participant; Peptides; Plasma; Preparation; Procedures; Process; Product Labeling; Quality Control; Radioactive Waste; Radioactivity; Radioimmunoconjugate; Radiolabeled; Reagent; Records; Regulation; Reporting; Research Personnel; Running; Sampling; Series; Serum; Services; Shipping; Ships; Site; Specific qualifier value; Specimen; Testing; Time; Urine; Waste Products; clinical research site; computerized data processing; day; dosimetry; experience; immunoreactivity; programs; quality assurance; radiotracer; size

The Radiolabeling, Quality Assurance, and Immunoassay Core will provide a variety of services for the participants of this Program Project. This Core Facility has been providing these same services to CMMI investigators for 20 years. The primary responsibility of this core involves the preparation of radiolabeled agents for investigators. This includes the processing, receipt, preparation, quality assurance and disposal of the radiolabeled materials. This laboratory has experience in preparing radiolabeled antibodies and peptides with 1311,1251,123I, " V 90Y, 188Re, 99mTc, 212Bi, and 67Ga. Each product that is produced undergoes a series of quality assurance checks, including ITLC, size-exclusion HPLC, and Immunoreactivity determinations. All equipment used in this laboratory is calibrated regularly and all procedures are performed under SOPs. This laboratory also produces radiolabeled investigational agents for a number of INDs, and has experience in developing procedures to ensure product stability when shipped to extramural investigational sites. This core is also involved in the processing of blood and urine samples used for pharmacokinetic analysis, as well as plasma samples for anti-antibody assays. This Core will be utilized by Projects 1,2, and 4.

放射性标记、质量保证和免疫测定核心将为 参与这个项目的人。该核心设施一直在为CMMI提供这些相同的服务 20年的调查。该核心的主要职责包括制备放射性标记的 调查员的代理人。这包括处理、接收、准备、质量保证和处置 放射性标记的物质。本实验室具有制备放射性标记抗体和肽的经验 1311、1251、123I、90Y、188Re、99mTc、212Bi和67Ga。生产的每一种产品都要经过一系列的 质量保证检查，包括ITLC、分子排阻HPLC和免疫反应性测定。 本实验室使用的所有设备均定期校准，所有程序均按照SOP进行。 该实验室还为许多IND生产放射性标记的研究药物， 制定程序，以确保产品在运送到院外研究中心时的稳定性。这 核心还参与处理用于药代动力学分析的血液和尿液样本，以及 作为血浆样品用于抗抗体测定。该核心将用于项目1、2和4。