Cell Therapy : cGMP Facilities and Manufacturing

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電子版価格
¥40,917

電子版あり

Cell Therapy : cGMP Facilities and Manufacturing

Gee, Adrian (EDT)

ウェブストア価格 ¥49,249（本体¥44,772）
Springer（2009/10発売）
外貨定価 US$ 219.99
ポイント 447pt

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ページ数 256 p.／サイズ 62 illus.
商品コード 9780387895833

基本説明

The source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring.

Full Description

Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional's library.

Additional topics in Cell Therapy: cGMP Facilities and Manufacturing...Standard operating procedures - Supply management - Facility equipment - Product manufacturing, review, release and administration - Facility master file.

I. Regulatory.- Regulation of Cell Product Manufacturing and Delivery: A United States Perspective.- The Regulatory Situation for Academic Cell Therapy Facilities in Europe.- A Regulatory System for Cell and Tissue Therapies: Proposed Approach in Australia.- II. GMP Facility Design.- University of Minnesota - Molecular and Cellular Therapeutics (MCT).- University of Pittsburgh Cancer Institute - Hematopoietic Stem Cell Laboratory (HSC Lab)/Immunological Monitoring and Cellular Products Laboratory (IMCPL).- Baylor College of Medicine - Center for Cell and Gene Therapy (CAGT).- Design of a New GMP Facility - Lessons Learned.- III. Professional Cell Therapy Standards.- AABB Cell Therapy Standards.- Professional Standards for Cellular Therapies: Foundation for the Accreditation of Cellular Therapy (FACT).- IV. Facility Operations.- Standard Operating Procedures.- Staffing, Training, and Competency.- Cleaning Procedures.- Environmental Monitoring.- Supply Management.- Facility Equipment.- Quality.- Product Manufacturing.- Product Review, Release, and Administration.- Use of a Facility Master File to Facilitate Regulatory Submissions for Cell Therapy Products.