Cell Therapy cGMP Facilities and Manufacturing /

• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Άλλοι συγγραφείς: Gee, Adrian (Επιμελητής έκδοσης)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Boston, MA : Springer US, 2009.
• Θέματα: Life sciences.; Cell biology.; Life Sciences.; Cell Biology.

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...

Πίνακας περιεχομένων:

• 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.