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.
Edited by:
Adrian Gee
Imprint: Springer-Verlag New York Inc.
Country of Publication: United States
Edition: 2009 ed.
Dimensions:
Height: 235mm,
Width: 155mm,
Spine: 23mm
Weight: 633g
ISBN: 9780387895833
ISBN 10: 0387895833
Pages: 256
Publication Date: 25 September 2009
Audience:
Professional and scholarly
,
Undergraduate
Format: Hardback
Publisher's Status: Active
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.
