Cell Therapy: Cgmp Facilities and Manufacturing

ISBN-13: 9783030755355 / Angielski / Twarda / 2021 / 502 str.

Adrian Gee

Spis treści

Part 1.     Regulatory

1.  Regulation of Cell Therapy in the United States 

2.   Regulatory Landscape and Emerging Trends In Advanced Therapies Manufacturing: An EU Perspective 

3.   Australian Cellular Therapy Regulations 

4.   Landscape for Regenerative Medicine Manufacturing in Japan 

5.   GLP Regulations for Non-clinical studies 

6.  Ethical Considerations in Cell Therapy 

7.  Investigational New Drug Applications for Cell Therapy Products

8.   FDA Inspections 

9.   Commercialization of Investigational Cell Therapy Products 

Part 2   Quality Systems

10.  The Meaning of Quality 

11.   Development and Maintenance of a Quality Program

12.   Quality Control of Cellular Therapy Products and Viral Vectors 

13.   Quality Management Software – Q-Pulse 

14.   Selection of Contract Manufacturing and Testing Organizations 

Part 3     Facility Design

15.   Introduction: Facility Design 

16.   PACT CPFs - Examples Describing Different Cell Processing Facility Designs

17. Design and Operation of a Multiuse GMP Facility at the City of Hope 

18. Design and Operation of a Multiuse GMP Facility at the University of Miami 

19.   Design of a New Academic GMP Facility for Today and Beyond at the Dana-Farber Cancer Institute

20.  Design and Licensure of an American Cord Blood Bank 

21.   Indiana University Vector Production Facility (IUVPF) 

22.   Qualification and Commissioning of a New GMP Facility 

Part 4    Facility Infrastructure

23.   Environmental Monitoring 

24.   GMP Facility Cleaning and Maintenance 

25.  GMP Documentation 

26.   Process Validation 

27.   Equipment Qualification 

28.  Vendor Qualification and Supply Management 

29.  Staffing, Training and Competency 

Part 5    Product Management

30.   Product Accessioning, Tracing and Tracking 

31.   ISBT 128 in Labeling of Cellular Therapy Products 

32.   Product Processing, Manufacturing and Administration 

33.   Transport and Shipment of Cellular and Gene Therapy Products 

34.    Regenerative Medicine: The Newest Cellular Therapy

35.     Cellular Therapy Applications for COVID-19 

Part 6    Professional Standards and Support Organizations

36.   Professional Standards for Cellular Therapy: The Foundation for the Accreditation of Cellular Therapy (FACT) 

37.   AABB Cell Therapy Standards

38.  USP Standards for Cell-based Therapies

39.   The Role of the National Institute of Standards Measurement Assurance for Cell Therapies

40.  National Science Foundation Engineering Research Center for Cell Manufacturing Technologies (CMaT) 

41.  Financial Considerations for Academic GMP Facilities 

42.  Governmental Support Opportunities for Cellular & Gene Therapies in the United States 

O autorze

Dr. Adrian Gee is currently Professor of Medicine & Pediatrics, Center for Cell & Gene Therapy at Baylor College of Medicine. He received his bachelor’s degree from the University of Birmingham, England, and his Ph.D. from the University of Edinburgh, Scotland. He completed postdoctoral training at the National Institutes of Health and the University of Toronto. He then joined the faculty at the University of Florida where he performed some of the first applications of immunomagnetic tumor purging in the United States, and his laboratory became a central cell processing facility for this procedure. He co-founded the International Society for Hematotherapy and Graft Engineering (ISHAGE, now ISCT), and the Journal of Hematotherapy (now Cytotherapy) and helped establish the stem cell transplantation program at the University of South Carolina. He then directed the Cell Processing Laboratory at the University of Texas MD Anderson Cancer Center until he joined the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine in Houston. The CAGT houses GMP manufacturing facilities for vectors and cell therapy products, and has been selected as one of the 5 national somatic cell therapy processing centers by the National Heart, Lung & Blood Institute. Dr. Gee was involved in the development of standards for the collection processing and transplantation of hematopoietic stem cells for the Foundation for the Accreditation of Cell Therapy (FACT), the American Association of Blood Banks and the National Marrow Donor Program.

Blurb

This new edition presents a fully-updated and expanded look at current Good Manufacturing Practice (cGMP) for cell therapy products. It provides a complete discussion of facility design and operation including details specific to cord blood banking, cell processing, vector production and qualification of a new facility. Several chapters cover facility infrastructure including cleaning and maintenance, vendor qualification, writing a Standard Operating Procedure, staff training, and process validation. The detailed and invaluable product information covers topics like labelling, release and administration, transportation and shipment, et al. Further chapters cover relevant topics like writing and maintaining investigational new drug applications, support opportunities in North America and the European Union, commercial cell processing and quality testing services, and financial considerations for academic GMP facilities. A chapter on future directions rounds out Cell Therapy: cGMP Facilities and Manufacturing making it essential reading for any cell therapy professional involved in the development, use, or management of this type of facility.