Cell Therapy
Springer-Verlag New York Inc.
978-1-4614-9793-6 (ISBN)
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.
| Erscheint lt. Verlag | 3.12.2014 |
|---|---|
| Zusatzinfo | XX, 256 p. |
| Verlagsort | New York, NY |
| Sprache | englisch |
| Maße | 155 x 235 mm |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie |
| Naturwissenschaften ► Biologie ► Allgemeines / Lexika | |
| Naturwissenschaften ► Biologie ► Genetik / Molekularbiologie | |
| Naturwissenschaften ► Biologie ► Mikrobiologie / Immunologie | |
| Naturwissenschaften ► Biologie ► Zellbiologie | |
| ISBN-10 | 1-4614-9793-0 / 1461497930 |
| ISBN-13 | 978-1-4614-9793-6 / 9781461497936 |
| Zustand | Neuware |
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