Cell Therapy: cGMP Facilities and Manufacturing

ISBN-13: 9780387895833 / Angielski / Twarda / 2009 / 278 str.

Adrian Gee

Opis

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

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Spis treści

Preface List of Contributors List of Acronyms Part I. Regulatory Chapter 1. Regulation of Cell Product Manufacturing and Delivery: A United States Perspective Chapter 2. The Regulatory Situation for Academic Cell Therapy Facilities in Europe Chapter 3. A Regulatory System for Cell and Tissue Therapies: Proposed Approach in Australia Part II. GMP Facility Design Chapter 4. University of Minnesota – Molecular and Cellular Therapeutics (MCT) Chapter 5. University of Pittsburgh Cancer Institute – Hematopoietic Stem Cell Laboratory (HSC Lab)/ Immunological Monitoring and Cellular Products Laboratory (IMCPL) Chapter 6. Baylor College of Medicine – Center for Cell and Gene Therapy (CAGT) Chapter 7. Design of a New GMP Facility – Lessons Learned Part III. Professional Cell Therapy Standards Chapter 8. AABB Cell Therapy Standards Chapter 9. Professional Standards for Cellular Therapies: Foundation for the Accreditation of Cellular Therapy (FACT) Part IV. Facility Operations Chapter 10. Standard Operating Procedures Chapter 11. Staffing, Training, and Competency Chapter 12. Cleaning Procedures Chapter 13. Environmental Monitoring Chapter 14. Supply Management Chapter 15. Facility Equipment Chapter 16. Quality Chapter 17. Product Manufacturing Chapter 18. Product Review, Release, and Administration Chapter 19. Use of a Facility Master File to Facilitate Regulatory Submissions for Cell Therapy Products

Blurb

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

This volume contains a collection of chapters authored by individuals who are active in the field of cell therapy product manufacturing. The collection and editing of these chapters was supported in part by the National Institutes of Health (National Heart, Lung and Blood Institute) program Production Assistance for Cellular Therapies (PACT).