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Cover: 9783030755355 | Cell Therapy | cGMP Facilities and Manufacturing | Adrian P. Gee
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Cell Therapy
cGMP Facilities and Manufacturing
Buch von Adrian P. Gee
Sprache: Englisch

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Beschreibung
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.
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.
Über den Autor
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.
Zusammenfassung

Fully updated and expanded second edition reflects all recent developments and changes in the field

Comprehensive coverage of essential information from ethical considerations and facility management to product tracing and labeling, staff training and much more

Covers other essential topics like quality management, professional standards, writing/maintaining Standard Operating Procedures, financial considerations for academic facilities, future directions, etc.

Inhaltsverzeichnis
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

Details
Erscheinungsjahr: 2021
Fachbereich: Allgemeines
Genre: Biologie
Rubrik: Naturwissenschaften & Technik
Thema: Lexika
Medium: Buch
Seiten: 712
Inhalt: x
692 S.
32 s/w Illustr.
75 farbige Illustr.
692 p. 107 illus.
75 illus. in color.
ISBN-13: 9783030755355
ISBN-10: 3030755355
Sprache: Englisch
Ausstattung / Beilage: HC runder Rücken kaschiert
Einband: Gebunden
Redaktion: Gee, Adrian P.
Herausgeber: Adrian P Gee
Auflage: 2nd ed. 2022
Hersteller: Springer International Publishing
Springer International Publishing AG
Maße: 241 x 160 x 44 mm
Von/Mit: Adrian P. Gee
Erscheinungsdatum: 11.11.2021
Gewicht: 1,221 kg
preigu-id: 119768479
Über den Autor
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.
Zusammenfassung

Fully updated and expanded second edition reflects all recent developments and changes in the field

Comprehensive coverage of essential information from ethical considerations and facility management to product tracing and labeling, staff training and much more

Covers other essential topics like quality management, professional standards, writing/maintaining Standard Operating Procedures, financial considerations for academic facilities, future directions, etc.

Inhaltsverzeichnis
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

Details
Erscheinungsjahr: 2021
Fachbereich: Allgemeines
Genre: Biologie
Rubrik: Naturwissenschaften & Technik
Thema: Lexika
Medium: Buch
Seiten: 712
Inhalt: x
692 S.
32 s/w Illustr.
75 farbige Illustr.
692 p. 107 illus.
75 illus. in color.
ISBN-13: 9783030755355
ISBN-10: 3030755355
Sprache: Englisch
Ausstattung / Beilage: HC runder Rücken kaschiert
Einband: Gebunden
Redaktion: Gee, Adrian P.
Herausgeber: Adrian P Gee
Auflage: 2nd ed. 2022
Hersteller: Springer International Publishing
Springer International Publishing AG
Maße: 241 x 160 x 44 mm
Von/Mit: Adrian P. Gee
Erscheinungsdatum: 11.11.2021
Gewicht: 1,221 kg
preigu-id: 119768479
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