2009

Cell Therapy

cGMP Facilities and Manufacturing

Editors:

ISBN: 978-0-387-89583-3 (Print) 978-0-387-89584-0 (Online)

Table of contents (19 chapters)

  1. Front Matter

    Pages i-xx

  2. Part I. Regulatory

    1. Front Matter

      Pages 1-1

    2. No Access

      Book Chapter

      Pages 3-25

      Regulation of Cell Product Manufacturing and Delivery: A United States Perspective

    3. No Access

      Book Chapter

      Pages 27-35

      The Regulatory Situation for Academic Cell Therapy Facilities in Europe

    4. No Access

      Book Chapter

      Pages 37-48

      A Regulatory System for Cell and Tissue Therapies: Proposed Approach in Australia

  3. Part II. GMP Facility Design

    1. Front Matter

      Pages 50-50

    2. No Access

      Book Chapter

      Pages 51-56

      University of Minnesota - Molecular and Cellular Therapeutics (MCT)

    3. No Access

      Book Chapter

      Pages 57-65

      University of Pittsburgh Cancer Institute - Hematopoietic Stem Cell Laboratory (HSC Lab)/Immunological Monitoring and Cellular Products Laboratory (IMCPL)

    4. No Access

      Book Chapter

      Pages 67-77

      Baylor College of Medicine - Center for Cell and Gene Therapy (CAGT)

    5. No Access

      Book Chapter

      Pages 79-84

      Design of a New GMP Facility - Lessons Learned

  4. Part III. Professional Cell Therapy Standards

    1. Front Matter

      Pages 86-86

    2. No Access

      Book Chapter

      Pages 87-95

      AABB Cell Therapy Standards

    3. No Access

      Book Chapter

      Pages 97-106

      Professional Standards for Cellular Therapies: Foundation for the Accreditation of Cellular Therapy (FACT)

  5. Part IV. Facility Operations

    1. Front Matter

      Pages 108-108

    2. No Access

      Book Chapter

      Pages 109-120

      Standard Operating Procedures

    3. No Access

      Book Chapter

      Pages 121-134

      Staffing, Training, and Competency

    4. No Access

      Book Chapter

      Pages 135-144

      Cleaning Procedures

    5. No Access

      Book Chapter

      Pages 145-155

      Environmental Monitoring

    6. No Access

      Book Chapter

      Pages 157-170

      Supply Management

    7. No Access

      Book Chapter

      Pages 171-186

      Facility Equipment

    8. No Access

      Book Chapter

      Pages 187-197

      Quality

    9. No Access

      Book Chapter

      Pages 199-213

      Product Manufacturing

    10. No Access

      Book Chapter

      Pages 215-228

      Product Review, Release, and Administration

    11. No Access

      Book Chapter

      Pages 229-236

      Use of a Facility Master File to Facilitate Regulatory Submissions for Cell Therapy Products

  6. Back Matter

    Pages 237-256