TAS::75 0872::TAS SMARTT (11-8470187)

塔斯马尼亚::75 0872::塔斯马特 (11-8470187)

基本信息

批准号：
8602369
负责人：
THOMAS VANCOTT
金额：
$ 218.91万
依托单位：
ADVANCED BIOSCIENCE LABORATORIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-11-08 至 2015-11-07
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8602369
关键词：
Agreement Althaea Biological Products Biological Response Modifier Therapy Businesses Certification Clinical Clinical Trials Complement Computer Systems Contracts Cyclic GMP DNA Data Development Drug Formulations Electronic Tracking Database Faculty Government Heart Diseases Hematological Disease Housing Lung diseases Maintenance Manuals Marketing Methodology Monitor National Heart, Lung, and Blood Institute Phase Preparation Procedures Process Production Protocols documentation Quality Control Reporting Request for Proposals Research Personnel Sampling Services Shipping Ships Site Visit Staging Surveys System Technology Testing Update Work Yeasts cGMP production cell bank cost design experience large scale production manufacturing process material transfer agreement member programs quality assurance satisfaction scale up web site

项目摘要

Participation as a member of the SMARTT Steering Committee (SC) and subcommittees as necessary to provide input to the overall SMARTT program. (Section 3.0) Contribution to the creation of a cGMP- and GLP-grade manual of procedures (MOP) with updates as necessary during the production phase (SMARTT Phase II). (Section 2.3.1) Development and implementation of Material Transfer Agreements (MTA) with input from NHLBI and the CC. (Section 2.3.2.1) Contribution to developing procedures for evaluating, prioritizing and processing Request for Services Applications (RSAs). (Section 2.3.2.2) These procedures will then be utilized in the production phase to evaluate each RSA, including completion of a Feasibility Assessment (FA). (Section 2.3.2.3) Contribution to the design and content of the Coordinating Center's (CC) customer satisfaction survey (Section 2.3.2.5), marketing plan (Section 2.3.4), public and private websites (Section 2.3.3), and the electronic database for tracking all biologics and data throughout the production process. ABL's computer system capabilities are also described. (Section 4.2) . Provision of services as a US FDA-defined cGMP production faculty for biological therapy products. Processing, analyzing (Section 2.3 .5), storing, and shipping products (Section 4.1.2) produced. Provision of translational support or manufacturing services to Investigators with requested biological therapy products. (Section 2.3.5) Provision of semi-annual production reports to the NHLBI PO and CO (Section 2.3.2.4), while constantly maintaining all required certifications and requirements to manufacture both nonclinical and clinical products; all data is available for the yearly site visits by the CC. Design and implementation of monitoring plans for products, including production and compliance with regulatory requirements. (Section 2.3.6) Maintenance of quality control and quality assurance plans for all biologics products. (Section 2.3.6) For each manufactured product, provision of complete protocol information, including quality control and quality assurance procedures, in accordance with the MOP, and preparation of archival samples from each lot manufactured. (Section 2.3.6) Provision of orderly closeout and termination of service agreements during the final months of the contract. (Section 2.3.2.6)

必要时作为 SMARTT 指导委员会 (SC) 和小组委员会的成员参与为整个 SMARTT 计划提供输入。（第 3.0 节）为创建 cGMP 和 GLP 级程序手册 (MOP) 做出贡献，更新内容为生产阶段（SMARTT 第二阶段）所必需的。（第 2.3.1 节）根据 NHLBI 和抄送。（第 2.3.2.1 节）协助制定评估、优先排序和处理服务请求的程序应用程序 (RSA)。（第 2.3.2.2 节）这些程序将在生产阶段使用评估每个 RSA，包括完成可行性评估 (FA)。（第 2.3.2.3 节）为协调中心 (CC) 客户满意度调查的设计和内容做出贡献（第 2.3.2.5 节）、营销计划（第 2.3.4 节）、公共和私人网站（第 2.3.3 节）以及用于跟踪整个生产过程中所有生物制品和数据的电子数据库。 ABL的电脑还描述了系统功能。（第 4.2 节）。作为美国 FDA 定义的生物治疗产品 cGMP 生产部门提供服务。加工、分析（第 2.3 .5 节）、存储和运输生产的产品（第 4.1.2 节）。向研究人员提供所需生物治疗的转化支持或制造服务产品。（第 2.3.5 节）向 NHLBI PO 和 CO 提供半年度生产报告（第 2.3.2.4 节），同时不断维持生产非临床和临床产品所需的所有认证和要求；所有数据均可供 CC 每年进行实地考察。监测计划的设计和实施产品，包括生产和遵守法规要求。（第 2.3.6 节）维护所有生物制品的质量控制和质量保证计划。（第 2.3.6 节）对于每个制造的产品，提供完整的协议信息，包括质量控制和根据 MOP 的质量保证程序，并准备每批的档案样品制造的。（第 2.3.6 节）在合同的最后几个月内有序收尾和终止服务协议。（第 2.3.2.6 节）