Gee Cell Therapy

cGMP Facilities and Manufacturing
1. Auflage 2009
ISBN: 978-0-387-89584-0
Verlag: Springer US
Format: PDF
Kopierschutz: 1 - PDF Watermark

E-Book, Englisch, 256 Seiten

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.

Autoren/Hrsg.

Gee, Adrian

Inhaltsverzeichnis

1;Preface;6
2;Acknowledgments;8
3;Contents;9
4;Contributors;11
5;Acronyms;14
6;Part I Regulatory;18
6.1;1 Regulation of Cell Product Manufacturing and Delivery: A United States Perspective;19
6.1.1; History of Cell Therapy Development;19
6.1.2; U.S. Food and Drug Administration (FDA);20
6.1.3; History of Regulation of Cell Therapies;20
6.1.3.1; CBER;21
6.1.3.2; CDRH;22
6.1.3.3; CDER;22
6.1.4; Combination Products;22
6.1.5; The IND Process;23
6.1.5.1; Who Needs an IND?;23
6.1.5.2; IND Sponsor/Investigator;23
6.1.5.3; Requesting a Meeting;23
6.1.5.4; Pre-IND Meeting;24
6.1.5.5; IND Submission;25
6.1.6; Chemistry, Manufacturing, and Control (CMC) Section;26
6.1.6.1; Chemistry and Manufacturing Introduction;28
6.1.6.2; Drug Substance;28
6.1.6.3; Drug Product;28
6.1.6.4; Placebo;28
6.1.6.5; Labeling;28
6.1.6.6; Pharmacology/Toxicology (Pharm/Tox) Section;29
6.1.7; Cross-Referencing;29
6.1.8; Type V Master File;29
6.1.9; Filing an IND;30
6.1.10; IND Maintenance;30
6.1.11; Current Good Manufacturing Practice (cGMP)and Cell Product Manufacturing;31
6.1.12; The IND/GMP Continuum;33
6.1.13; GMP Components;34
6.1.13.1; Staff Training;34
6.1.13.2; SOP Development;34
6.1.13.3; Processing Records;34
6.1.13.4; Equipment Records, Calibration, and Cleaning;35
6.1.13.5; Facility Requirements;35
6.1.13.6; Validation Procedures;35
6.1.13.7; Quality Assurance (QA)/Quality Control Program;35
6.1.13.8; Management Systems;35
6.1.13.9; Controlled Labeling Operations;36
6.1.13.10; Release Criteria Principles;36
6.1.13.11; Delivery of Cellular Products;37
6.1.14; Conclusion;38
6.1.15; Special Considerations: Umbilical Cord Blood;38
6.1.16;References;39
6.2;2 The Regulatory Situation for Academic Cell Therapy Facilities in Europe;42
6.2.1; The European Union (EU) Directive on Quality and Safety of Tissue and Cells;42
6.2.2; The EU Medicinal Products Directive;45
6.2.3; Advanced Cell Therapies;47
6.2.4; An Example of European Regulatory Status The Situation in France;48
6.2.5; Links;50
6.2.6;References;50
6.3;3 A Regulatory System for Cell and Tissue Therapies: Proposed Approach in Australia;51
6.3.1; Introduction;51
6.3.2; A Digression The Regulation of Therapeutic Goods in Australia;53
6.3.3; Current Regulation of Biological Therapies in Australia;54
6.3.4; Development of a Regulatory Framework for Celland Tissue Therapies in Australia;56
6.3.5; Assessment of the Manufacturing Process;60
6.3.6; Oversight of Clinical Development;60
6.3.7; Conclusion;61
6.3.8;References;61
7;Part II GMP Facility Design;63
7.1;4 University of Minnesota - Molecular and Cellular Therapeutics (MCT);64
7.1.1; Overview;64
7.1.2; Facility Design;65
7.1.3; Aspects of Facility Design;66
7.1.4;References;68
7.2;5 University of Pittsburgh Cancer Institute - Hematopoietic Stem Cell Laboratory (HSC Lab)/Immunological Monitoring and Cellular Products Laboratory (IMCPL);70
7.2.1; Introduction;70
7.2.2; Heating, Ventilation, and Air Conditioning (HVAC) System;71
7.2.3; Hematopoietic Stem Cell Laboratory (HSC Lab);72
7.2.4; Immunological Monitoring and Cellular Products Laboratory (IMCPL);74
7.2.5; Laboratory Features: What We Would Retain and What We Would Change;76
7.2.6;References;77
7.3;6 Baylor College of Medicine - Center for Cell and Gene Therapy (CAGT);79
7.3.1; Introduction;79
7.3.2; Vector Production Facility (VPF);82
7.3.3; Cell Processing Facility (CPF);83
7.3.4; The New CAGT Facilities;89
7.3.5; General Comments;89
7.4;7 Design of a New GMP Facility - Lessons Learned;90
7.4.1; Introduction;90
8;Part III Professional Cell Therapy Standards;96
8.1;8 AABB Cell Therapy Standards;97
8.1.1; AABB: History and Evolution;97
8.1.2; Development and Evolution of Standards;98
8.1.3; Quality Systems Approach to Cellular Therapies;99
8.1.4; Transparency in Standards-Setting;100
8.1.5; Assessing Conformance to Standards;103
8.1.6; Accreditation;103
8.1.7; Validation of Assessments;104
8.1.8; Technical Highlights of the Third Edition;104
8.1.9;References;105
8.2;9 Professional Standards for Cellular Therapies: Foundation for the Accreditation of Cellular Therapy (FACT);106
8.2.1; Historical Background;106
8.2.2; FACT Standards;108
8.2.3; FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration;109
8.2.4; NetCord-FACT International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection, and Release;110
8.2.5; Accreditation;111
8.2.6;References;114
9;Part IV Facility Operations;116
9.1;10 Standard Operating Procedures;117
9.1.1; Introduction;117
9.1.2; Types of SOPs;118
9.1.3; Document Control;119
9.1.4; Numbering Systems for SOPs;119
9.1.5; Formatting and Content of SOPs;120
9.1.6; Writing SOPs;121
9.1.7; Validation Plans;122
9.1.8; Document Approval;123
9.1.8.1; New SOPs;123
9.1.8.2; Revised SOPs;123
9.1.8.3; Retired SOPs;125
9.1.8.4; Document Distribution and Availability;125
9.1.8.5; Production Batch Records (PBR);125
9.1.8.6; Training Documentation;126
9.1.8.7; Archival of SOPs;126
9.1.8.8; Annual Review;126
9.1.9; Useful Literature ;128
9.2;11 Staffing, Training, and Competency;129
9.2.1; Introduction;129
9.2.2; Analysis;130
9.2.3; Job Description;130
9.2.4; Training Regulations;132
9.2.5; Design of Training Program;133
9.2.6; The Adult Learner;135
9.2.7; e-Learning;136
9.2.8; Development;137
9.2.9; Implementation;138
9.2.10; Evaluation;138
9.2.11; Competence;138
9.2.12; Remediation;140
9.2.13; Recordkeeping;141
9.2.14; Conclusion;141
9.2.15;References;141
9.3;12 Cleaning Procedures;143
9.3.1; Choices and Getting Started;143
9.3.2; Schedules and Practices;146
9.3.3; Validation of Cleaning;148
9.3.4; Equipment Cleaning;149
9.3.5; Changeover Procedures;151
9.3.6; Summary;151
9.3.7; Useful Literature ;152
9.4;13 Environmental Monitoring;153
9.4.1; Regulations;153
9.4.2; Good Tissue Practices (GTP);153
9.4.3; Good Manufacturing Practices (GMP);154
9.4.4; Academic GMP and GTP;154
9.4.5; Elements of Environmental Monitoring;156
9.4.6; Air Handling;156
9.4.7; Monitoring Frequency;158
9.4.8; Changeover Procedures;159
9.4.9; Interpretation of Data;159
9.4.10; Databases;161
9.4.11; Summary;163
9.4.12;Useful Literature ;163
9.5;14 Supply Management;164
9.5.1; Regulatory Requirements;164
9.5.2; Good Tissue Practice (GTP) Regulations;164
9.5.3; Good Manufacturing Practice (GMP) Regulations;165
9.5.4; Establishing a System;166
9.5.5; Approved Supplies;167
9.5.6; Supply Release Specifications;167
9.5.7; Parts Lists;170
9.5.8; Receipt of Supplies;170
9.5.9; Supply Release;173
9.5.10; Storage;173
9.5.11; Released Supply Management;173
9.5.12; Formulations;175
9.5.13; Reagents Prepared In-House;176
9.5.14; Expired Materials;176
9.5.15; Updates;176
9.5.16;Useful Literature;177
9.6;15 Facility Equipment;178
9.6.1; Introduction;178
9.6.2; Equipment Selection;178
9.6.2.1; Design Qualification (DQ);178
9.6.2.2; Choosing Equipment;179
9.6.2.3; Capital Budgeting;180
9.6.2.4; Warranties and Service Contracts;181
9.6.3; Qualification;182
9.6.3.1; Qualification Versus Validation;182
9.6.3.2; Installation Qualification (IQ);183
9.6.3.3; Operational Qualification (OQ);183
9.6.3.4; Process/Performance Qualification (PQ);184
9.6.3.5; Operator Qualification;185
9.6.4; Equipment Prioritization and Backup;185
9.6.5; Quality Control (QC) and Documentation;186
9.6.6; Retiring Equipment;188
9.6.7; Regulations and Standards;189
9.6.8;References;192
9.7;16 Quality;194
9.7.1; Introduction;194
9.7.2; Designing a Quality Management Program;195
9.7.3; Monitoring Quality Systems;196
9.7.3.1; Audits;198
9.7.4; Improving Cellular Therapy Services;201
9.7.4.1; Quality Improvement;202
9.7.5; Conclusions;203
9.7.6;References;203
9.8;17 Product Manufacturing;205
9.8.1; Design of the Manufacturing Procedure;205
9.8.2; Production Monitoring;209
9.8.3; Review;210
9.8.4; Release Testing;212
9.8.5; Ancillary Records;216
9.8.6; Product Storage and Release;216
9.8.7; Conclusion;218
9.8.8;References;218
9.9;18 Product Review, Release, and Administration;220
9.9.1; Understanding Product Review and Release;220
9.9.2; Regulatory Issues;221
9.9.3; Product Review and Documentation;222
9.9.4; Product Testing for Release;223
9.9.4.1; Sterility Testing;226
9.9.4.2; Mycoplasma Testing;226
9.9.4.3; Purity;227
9.9.4.4; Viability;227
9.9.4.5; Identity Testing;227
9.9.4.6; Out-of-Specification (OOS) Results;229
9.9.5; Product Release, Transportation, and Shipment;230
9.9.6; Administration;231
9.9.7; Conclusions;231
9.9.8;References;232
9.10;19 Use of a Facility Master File to Facilitate Regulatory Submissions for Cell Therapy Products;234
9.10.1; Definition and Types of Master Files;234
9.10.2; Use and Content of the Cell Therapy Facility Master File;235
9.10.3; Writing the Cell Therapy Facility Master File;238
9.10.4; Options for Use of Master File as a Formal FDA Submission Versus an Internal Document;239
9.10.5; Summary;240
9.10.6;References;241
9.11; Appendix A Template Form referred to in Chapter 15 - Facility Equipment;242
9.11.1; Form A;242
9.12; Appendix B Template Form referred to in Chapter 15 - Facility Equipment;243
9.12.1; Form B -- Equipment Discard;243
9.13; Appendix C Template Form referred to in Chapter 15 - Facility Equipment;245
9.13.1; Form C -- Quality Control of Laboratory Scales;245
9.14; Appendix D Template Form referred to in Chapter 15 - Facility Equipment;246
9.14.1; From D -- Sample Policy New Equipment Qualification;246
9.15; Appendix E Template Form referred to in Chapter 15 - Facility Equipment ;247
9.15.1;From E – Sample QC SOP Quality Control Procedure for Scale;247
9.16;Index;249