Cell therapy : cGMP facilities and manufacturing / Adrian Gee, editor.

Format:

Book

Contributor:

Gee, Adrian P.

Language:

English

Subjects (All):

Cell Transplantation--standards.

Drug Industry--standards.

Facility Regulation and Control.

Quality Control.

Cyclic guanylic acid--Therapeutic use.

Cyclic guanylic acid.

Cellular therapy.

Medical Subjects:

Cell Transplantation--standards.

Drug Industry--standards.

Facility Regulation and Control.

Quality Control.

Physical Description:

xx, 256 pages : illustrations

Place of Publication:

New York : Springer, [2009]

Summary:

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 includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional's library.

Additional topics in Cell Therapy: cGMP Facilities and Manufacturing...

Standard operating procedures

Supply management

Facility equipment

Product manufacturing, review, release and administration

Facility master file

This volume contains a collection of chapters authored by individuals who are active in the field of cell therapy product manufacturing. The collection and editing of these chapters was supported in part by the National Institutes of Health (National Heart, Lung and Blood Institute) program Production Assistance for Cellular Therapies (PACT).

Contents:

Part I Regulatory

1 Regulation of Cell Product Manufacturing and Delivery: A United States Perspecive / R.W. Lindblad 3

2 The Regulatory Situation for Academic Cell Therapy Facilities in Europe / I. Slaper-Cortenbach, M. Scott, D. Herrmann, M. Introna, K. Theunissen, P. Theocharous, C. Chabannon 27

3 A Regulatory System for Cell and Tissue Therapies: Proposed Approach in Australia / A. Farrugia 37

Part II GMP Facility Design

4 University of Minnesota - Molecular and Cellular Therapeutics (MCT) / D.H. McKenna, Jr. 51

5 University of Pittsburgh Cancer Institute - Hematopoietic Stem Cell Laboratory (HSC Lab)/Immunological Monitoring and Cellular Products Laboratory (IMCPL) / D.L. Griffin, A.D. Donnenberg, T.L. Whiteside 57

6 Baylor College of Medicine - Center for Cell and Gene Therapy (CAGT) / A. Gee 67

7 Design of a New GMP Facility - Lessons Learned / A. Gee 79

Part III Professional Cell Therapy Standards

8 AABB Cell Therapy Standards / Z.M. Szczepiorkowski, E. Nunes 87

9 Professional Standards for Cellular Therapies: Foundation for the Accreditation of cellular Therapy (FACT) / P.I. Warkentin 97

Part IV Facility Operations

10 Standard Operating Procedures / C.G. Lindgren 109

11 Staffing, Training, and Competency / D.M. Kadidlo 121

12 Cleaning Procedures / A. Gee, D.L. Lyon 135

13 Environmental Monitoring / A. Gee, D.L. Lyon 145

14 Supply Management / A. Gee, C.M. Rooney 157

15 Facility Equipment / D.L. Griffin 171

16 Quality / J.W. Atkins 187

17 Product Manufacturing / A. Gee 199

18 Product Review, Release, and Administration / N.H. Collins 215

19 Use of a Facility Master File to Facilitate Regulatory Submissions for Cell Therapy Products / E.J. Read, H.M. Khnu 229.

Notes:

Includes bibliographical references and index.

ISBN:

9780387895833

0387895833

9780387895840

0387895841

OCLC:

432990104