cGMP Facilities and Manufacturing
Buch, Englisch, 256 Seiten, Paperback, Format (B × H): 155 mm x 235 mm, Gewicht: 423 g
ISBN: 978-1-4614-9793-6
Verlag: Springer US
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.
Zielgruppe
Research
Autoren/Hrsg.
Fachgebiete
- Naturwissenschaften Biowissenschaften Molekularbiologie
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Vorklinische Medizin: Grundlagenfächer Humangenetik
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Klinische und Innere Medizin Gentherapie
Weitere Infos & Material
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.
