BookAdrian Gee, editor.
Contents:
Part 1. Regulatory.
Regulation of Cell Product Manufacturing and Delivery: A United States Perspective / R.W. Lindblad
The Regulatory Situation for Academic Cell Therapy Facilities in Europe / I. Slaper-Cortenbach, M. Scott, D. Herrmann, M. Introna and K. Theunissen, et al.
A Regulatory System for Cell and Tissue Therapies: Proposed Approach in Australia / A. Farrugia
Part 2. GMP Facility Design.
University of Minnesota - Molecular and Cellular Therapeutics (MCT) / D.H. McKenna
University of Pittsburgh Cancer Institute - Hematopoietic Stem Cell Laboratory (HSC Lab)/Immunological Monitoring and Cellular Products Laboratory (IMCPL) / D.L. Griffin, A.D. Donnenberg and T.L. Whiteside / Baylor College of Medicine - Center for Cell and Gene Therapy (CAGT) / A. Gee
Design of a New GMP Facility - Lessons Learned / A. Gee
Part 3. Professional Cell Therapy Standards.
AABB Cell Therapy Standards / Z.M. Szczepiorkowski and E. Nunes
Professional Standards for Cellular Therapies: Foundation for the Accreditation of Cellular Therapy (FACT) / P.I. Warkentin
Part 4. Facility Operations
Standard Operating Procedures / C.G. Lindgren
Staffing, Training, and Competency / D.M. Kadidlo
Cleaning Procedures / A. Gee and D.L. Lyon
Environmental Monitoring / A. Gee and D.L. Lyon
Supply Management / A. Gee and C.M. Rooney
Facility Equipment / D.L. Griffin
Quality / J.W. Atkins
Product Manufacturing / A. Gee
Product Review, Release, and Administration / N.H. Collins
Use of a Facility Master File to Facilitate Regulatory Submissions for Cell Therapy Products / E.J. Read and H.M. Khuu.