Cellular Therapy: Principles, Methods and Regulations 2nd Edition

  • ID: 3621133
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This manual was designed as a compendium of state-of-the-art practices and methods for developing and producing cellular therapy products, and for development and operation of a cellular therapy facility, whether for research, translational or clinical. Applicable to academia, government and industry, it is also an essential reference for those in regulatory affairs and quality assurance as well as for laboratory technologists, managers, directors, physicians and scientists. Through descriptions of the rationale and methodology for a variety of cell processing and evaluation techniques, it will assist laboratory staff in developing procedures that comply with applicable regulations and standards. In addition to numerous examples and templates for laboratory document preparation, several methods are provided that include a general overview of the critical steps, materials and equipment used in each process. Each section has been compiled and edited by a team of experts in the field, with subchapters contributed by specialists in the specific subject matter. As regenerative medicine becomes more integrated into the field, considerations for regenerative therapies are also integrated within each section.

Chapters cover:

Regulatory considerations:
Including updated FDA tips and perspectives, IND and BLA processes, sample outlines, etc.
New in this edition: International regulation of cell therapy products.

Quality assurance:
Including process control, records, audits, equipment, personnel, validation, etc.

Aseptic processing, computer systems, safety and procedures for facility control.

Product and Process development:
New in this edition: Pre-clinical testing and early phase trial development.

Collection of Cells:
Marrow, apheresis and cord blood techniques.

Manufacturing Methods:
In this edition: Updated techniques for cell separation, cell expansion and graft engineering including production of dendritic, mesenchymal, pancreatic islet, iPS, and other therapeutic cells.

Handling of Processed Products:
Including shipping and handling; product release; patient preparation, infusion, and reactions; etc.

New in this edition: Biorepositories:
Including operational, regulatory and ethical considerations for storage of research samples.

Product characterization:
Including assessments of viability, potency, cytotoxicity, contamination, testing, etc., as well as validation of test methods.
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About the Editors

Regulatory Considerations for Manufacturing Cellular Therapies in the United States
Section Editor: Victoria A Lake, BSc, BA, RAC

1. A Brief History of US FDA Regulation of Human Cells and Tissues
Liana Harvath, PhD
HPC from Placental/Umbilical Cord Blood and Peripheral Blood
Proposed Approach to Regulation of Cellular and Tissue-Based Products
Future Directions

2. The FDA Perspective on the Manufacturing, Production, and Processing of Regulated Cellular Therapies
Eric Dollins, PhD; Patrick Lynch, PhD; Prajakta Varadkar, PhD; and Keith Wonnacott, PhD
General Tips
cGMPs for Phase 1 Clinical Trials

3. Regulatory Considerations for Other Cellular Therapies
Martha Wells, RAC, MPH
Regulatory Pathways
Sources of Novel Cellular Therapies
Future Considerations

4. Cellular Therapies Regulated as Combination Products
Joyce L Frey-Vasconcells, PhD
What Is the Definition of a Combination Product?
Who Determines Which Center Will Have Review Responsibility for a Combination Product?
Can the Applicant Determine Which Center Will Review the Product?
What Regulations Need Clarification from the FDA?

5. The Investigational New Drug Application
David H McKenna, Jr, MD; Victoria A Lake, BSc, BA, RAC; and Darin J Weber, PhD
Chemistry, Manufacturing, and Controls Section
Appendix 5-1 Sample Outline for Preparing the Chemistry, Manufacturing, and Controls Section of an Investigational New Drug Application

6. Biologics License Applications for Cellular Therapies
Rafael Cassata, MS, RAC (US, EU)
Pre-BLA Submission Activities
Review Timelines
Appendix 6-1 Sample Outline for the Content and Organization of a Biologics
License Application

7. Electronic Submissions of Cellular Therapy Investigational New Drug and Biologics License Applications
Daniel P Offringa
Brief History
Advantages of Electronic Submissions over Paper
Initial Considerations
Finalizing the Submission

8. International Regulation of Cellular Therapy Products
Rafael Cassata, MS, RAC (US, EU)
European Union
Appendix 8-1 Global Cellular Therapy Regulatory Bodies and Organizations

Quality Assurance for Cellular Therapy Facilities
Section Editors: Lizabeth Cardwell, MT(ASCP), MBA, RAC, and Michele W Sugrue, MS, MT(ASCP)SBB
Origins of Quality Concepts
Evolution of Cellular Therapy Quality Programs

9. Quality and Process Control
Lizabeth Cardwell, MT(ASCP), MBA, RAC; and Michele W Sugrue, MS, MT(ASCP)SBB
Quality Control
Change Control
Process Verification and Validation
Process Simulation
Product Contamination and Cross-Contamination
Donor Eligibility
Recovery or Collection
Tracking and Traceability
Storage Controls
Transportation Controls
Receipt, Predistribution Shipment, and Distribution of HCT/Ps
Appendix 9-1 Incoming Critical Supplies
Appendix 9-2 Sample Change-Control Form
Appendix 9-3 Document Format for General Process Validation Protocol
Appendix 9-4 Product Changeover Record
Appendix 9-5 Sample Product Tracking Form

10. Cell and Tissue Donor Qualification Processes: Evaluation and Eligibility
Lisa Phillips Johnson, MT(ASCP)SBB, CQA(ASQ)COM-OE, and
Rafael Cassata, MS, RAC (US, EU)
Quality Management Program Topics
Medical Suitability
Other Donor Testing Topics
Donor Eligibility Determination
Other Donor Eligibility Topics
References/ Resources

11. Human Resources in the Cellular Therapy Facility
Kevin L Bundy, BB, MT(ASCP)SBB; Brenda Alder, MS, MT(ASCP)SBB;
Lizabeth Cardwell, MT(ASCP), MBA, RAC; and Michele W Sugrue, MS, MT(ASCP)SBB
Personnel Requirements and Selection
Applicant Interview
Academic Transcripts
Performance Appraisals
Continuing Education
Position Description Review Process
Proficiency Testing
Appendix 11-1 Sample Policy for Personnel, Training, and Competency
Appendix 11-2 Sample Position Description for Cellular Therapy Specialist
Appendix 11-3 Sample Position Description for Quality Assurance Specialist
Appendix 11-4 Sample Cellular Therapy Facility Training Checklist
Appendix 11-5 Sample Competency Assessment Policy
Appendix 11-6 Sample Cellular Therapy Facility Competency Assessment Checklist
Appendix 11-7 Sample Competency Assessment Form
Appendix 11-8 Sample Policy for a Continuing Education Program

12. Equipment Management in the Cellular Therapy Facility
Tao Wang, MS, and Dave Krugh, MT(ASCP)SBB, CLS, CLCP(NCA)
Equipment Qualification
Equipment Quality Control
Record Retention
Appendix 12-1 Critical Equipment Selection Form
Appendix 12-2 Equipment Qualification Form
Appendix 12-3 New Equipment Qualification Checklist
Appendix 12-4 Equipment Activity Log
Appendix 12-5 Equipment Requalification Checklist
Appendix 12-6 Equipment Cleaning Log

13. Quality Assurance of Supplies and Materials for Cellular Therapy Facilities
Renee Smilee, MT(ASCP)
Defining Critical Materials
Supplier Agreements
Receipt, Inspection, and Testing of Supplies
Appendix 13-1 Supplier Qualification Survey
Appendix 13-2 Supplies Approved Inventory Log
Appendix 13-3 Material/Component Inspection Form

14. Audits of Cellular Therapy Facilities
Sharon E Tindle, MS, CQA(ASQ)
External Audits
Internal Audits
Audit Schedule
Auditor Qualification and Training
Auditing Methods

15. Documents and Records
Leigh Sims Poston, BS, MT(ASCP), and Betsy W Jett, MT(ASCP), CQA, CQM/OE(ASQ)
Documentation as Part of a Value-Driven Process
Characteristics of an Effective Document
Document Management
Characteristics of an Effective Record
Record Management
Appendix 15-1 Document Example: HPC(A) Collection Label
Appendix 15-2 Document Example: HPC(M) Collection Label
Appendix 15-3 Record Example: HPC(A) Collection Label
Appendix 15-4 Record Example: MNC(A) Collection Label
Appendix 15-5 Record Example: T Cells(A) Final Label

16. Standards and Accreditation for Cellular Therapies
Carolyn A Keever-Taylor, PhD
Cellular Therapy Product Standards
Foundation for the Accreditation of Cellular Therapy
National Marrow Donor Program
The College of American Pathologists
ISBT 128 for Cellular Therapy
Circular of Information
Standards Harmonization
Achieving Accreditation

17. Approaches to Validation for Cellular Therapy Products
Timothy Houck and Gary C du Moulin, PhD, MPH
Unique Requirements for the Validation of Cellular Therapy Products
Validation of Ancillary Processes
Elements of a Validation Program
PPQ for CT Products
Maintaining a State of Validation
Process or Product Changes

Facilities: General Procedures
Section Editor: John R Godshalk, MSE, MBA

18. Key Considerations and General Procedures for Facilities
John R Godshalk, MSE, MBA, and Robert A Preti, PhD
Manufacturing Area Requirements
Manufacturing Support Area Requirements
QC Laboratory and Microbiology Laboratory Requirements
Information Technology Infrastructure
Mechanical and Utility Requirements
Warehouse Requirements

19. Aseptic Processing
John Godshalk, MSE, MBA
The Environment
Closed Systems
Validation of Aseptic Processing

20. Cross-Contamination Issues in the Manufacture of Cellular Therapy Products
John Finkbohner, PhD
Identifying Process Risks: Process Mapping
Minimizing Process Risks: Optimizing Manufacturing Unit Operations and Validating
Unit Operation Robustness
Minimizing Process Risks: Controlling Routine Operation Variables

21. Computer Systems in the Cellular Therapy Facility
AA Geoffrey Browne and John R Godshalk, MSE, MBA
Computer System Selection
Computer System Validation
Computer System Operation
Regulations for Software Used in the Production of Cellular Therapy Products
Appendix 21-1 Sample Computer System Selection Plan
Appendix 21-2 Sample Computer System Installation Plan
Appendix 21-3 Sample Computer System Validation Plan
Appendix 21-4 Sample Computer System Test Case

22. Maintaining Safety in Cellular Therapy Facilities through Quality Assurance
Florinna Estioco Dekovic, MT(ASCP)BB, CQA(ASQ)
The Facility Designed for Security
Personal Hygiene Practices
Protection of Personnel in the Cellular Manufacturing Facility
Aseptic Technique
Emergency Preparedness and Action Plans
Contamination Control
Ergonomic Safety
Safety in the Use of Compressed-Gas Cylinders
Material Safety Data Sheets and Hazardous Materials

Process and Product Development for Cellular Therapeutics in Early-Phase Trials
Section Editor: Robert Lindblad, MD

23. Building a Team for Cellular Therapies in Early-Phase Trials
Deborah A Wood, MT(ASCP)
Building a Team

24. Manufacturing for Cellular Therapeutics in Early-Phase Trials
Adrian P Gee, PhD
Manufacturing Regulations
Development of the Manufacturing Process
Manufacturing Methods
Chemistry, Manufacturing, and Controls Section of the IND Application
Product Distribution, Administration, Recalls, and Complaints
Appendix 24-1 FDA Guidance Documents for the Cellular Product Manufacturer

25. Preclinical Testing for Early-Phase Cellular Therapy Products
John M Centanni, MS
Preclinical Study Conduct
Proof of Concept Studies
Preclinical Safety Testing
Preclinical Safety Protocol Design
Appendix 25-1 Sample Pulmonary/Mesenchymal Stem Cell Preclinical Animal Safety

26. Key Considerations in Developing Pluripotent Stem-Cell-Derived Therapeutics
Derek J Hei, PhD
Early-Stage Development Considerations
Production of Material for Preclinical Animal Studies
PSC Bank Production and Testing
Production of the Final Cell Product

Collection of Cells for Transplantation and Other Cellular Therapies
Section Editor: Michele Cottler-Fox, MD
Background and Historical Perspective
Current State of the Field
Overview of Section V
Future Directions

27. Bone Marrow Collection
Thomas R Spitzer, MD
Development of Human Marrow Collection Technique
Collection Technique
Postoperative Care
Nucleated Cell Yield and Quality Control
Donor Complications
Additional Issues
Bone Marrow Harvesting and Regenerative Medicine

28. Collection of Cellular Therapy Products by Apheresis
Laura S Connelly-Smith, MBBCh, DM, and Michael L Linenberger, MD, FACP
HPC Mobilization Regimens and Kinetics
Instruments and Methodologies for HPC(A) Collection
Standard Procedures for HPC(A) Collections
Collecting HPC(A) from Pediatric Donors
Adverse Effects and Complications of CD34+ Cell Mobilization and HPC(A) Collection
Appendix 28-1 Examples of Treatment Plans from Three Institutions for Adult Mononuclear
Cell Collection by Leukocytapheresis
Appendix 28-2 Examples of Treatment Plans from Three Institutions for Adult Large-Volume
Mononuclear Cell Collection by Leukocytapheresis
Appendix 28-3 Example of a Treatment Plan for Modified Anticoagulation for Apheresis
Appendix 28-4 Example of an Apheresis Flow Sheet
Appendix 28-5 Cellular Therapy—Hematopoietic Progenitor Cell (HPC) Apheresis
Disclosure Form

29. Umbilical Cord Blood Collection
Joanne Kurtzberg, MD
Collection Methods Refined
Comparing Cord Blood Collection Methods
Microbial Contamination: In Utero vs Ex Utero
Other Factors That Affect UCB Collection Quality
Techniques to Improve Cord Blood Collection

30. Collection of Other Cells and Tissues
Naynesh R Kamani, MD
Cells of Hematopoietic Origin
Cells of Nonhematopoietic Origin
Other Cells and Tissues Currently Collected for Research and Clinical Trials
Regulatory Requirements

Methods for Cells and Tissues for Therapeutic Use
Section Editors: Diane Kadidlo, MT(ASCP)SBB, and David H McKenna, Jr, MD

31. Basic Cellular Therapy Manufacturing Procedures
David H McKenna, Jr, MD
Basic Procedures

32. Umbilical Cord Blood Processing
Philip H Coelho, BSME; Diane Kadidlo, MT(ASCP)SBB; and John Chapman, PhD
Manual Processing of Cord Blood
Automated Processing of Cord Blood
Current State of the Field

33. Hematopoietic Progenitor Cell Graft Modification: Cell Enrichment or Depletion
Diane Kadidlo, MT(ASCP)SBB
Cell Isolation Methods
Cell Enrichment

34. Cell Separation by Counterflow Centrifugal Elutriation
Julie Edwards, BS, MT(ASCP)

35. Hematopoietic Progenitor Cell Culture and Expansion
John D McMannis, PhD
HPC Expansion Overview
UCB Expansion
Culture Vessels and Devices

36. Regulatory T Cells
Keli L Hippen, PhD, and David H McKenna, Jr, MD

37. Natural Killer Cells
David H McKenna, Jr, MD, and Jeffrey S Miller, MD

38. T-Cell Expansion: Cytotoxic T Cells
Jerome Ritz, MD
Methods for In Vitro Isolation and Expansion

39. Allogeneic T-Cell Therapy Using Rapamycin-Resistant CD4+ T Cells
(T-Rapa Cells)
Daniel H Fowler, MD; Vicki Fellowes, MT(ASCP); and Hanh Khuu, MD
Current State of the Field
Future Directions

40. Human Mesenchymal Stromal Cells
Karen Bieback, PhD, and Hermann Eichler, MD
Production of Human MSCs
Characterization of MSCs In Vitro

41. Dendritic Cell Vaccines
Lisa H Butterfield, PhD

42. Pancreatic Islet Cells
Elina Linetsky, PhD, and Camillo Ricordi, MD
Historical Perspective
Donor Selection
Islet Isolation
Islet Purification

43. Human iPS Cells—cGMP Production
Patrick Walsh, MSc; Kristin Voltzke, MPH; Ann M Parr, MD, PhD; and
James R Dutton, PhD

44. Regenerative Medicine Approaches for Cell and Tissue Therapies
Prafulla Chandra; Bryan Tillman, MD, PhD; Anthony Atala, MD; and
James J Yoo, MD, PhD
Components of Regenerative Medicine
Regenerative Medicine Therapies
Tissue-Based Regenerative Therapies

45. Cryopreservation of Cellular Therapy Products
Allison Hubel, PhD, and Aby J Mathew, PhD
Elements of a Cryopreservation Protocol

46. Cryopreservation Containers for Cellular Therapy Products
Herbert M Cullis, MT
Laboratory Practices
Controlled-Rate Freezing

Handling of Processed Cellular Therapy Products
Section Editor: Fran Rabe

47. Thawing and Infusing Cellular Therapy Products
Richard L Haspel, MD, PhD
Thawing of Cellular Therapy Products
Infusion of Cellular Therapy Products

48. Cellular Therapy Product Release
Fran Rabe
Quality Unit Role
Typical Product Release Criteria
Quality Unit Review of Manufacturing for Release
Two-Phased Review
Handling Lot-Release Criteria That Have Not Been Met
Quality Unit Rejection of Product
Management of Post-Lot-Release “Unexpected” Information
Appendix 48-1 Quality Unit Review for Allogeneic Products with Modular Batch Production
Record (BPR)
Appendix 48-2 Quality Unit Review for Autologous Products with Placebo
Appendix 48-3 Quality Unit Review for Autologous Tissue Products
Appendix 48-4 Quality Unit Review of Autologous Products with Placebo Type 2

49. Transportation and Shipping of Cellular Therapy Products
Donna Regan, MT(ASCP)SBB, and Angela Yost, MLS(ASCP)CM
Limitations and Recommendations
Responsibilities of Personnel Involved with Transport
Communication: General Guidelines
Logistical Considerations
Quality Control: Dry Shippers
Quality Control: Noncryopreserved Shipping Containers
Section Editor: Elizabeth L Wagner, MPH

50. Issues in Operating a Human Tissue Biorepository Supporting Biomedical Research
William E Grizzle, MD, PhD; Katherine C Sexton, MBA; and Walter C Bell, MD
Goals and Design
Collection of Human Tissue Specimens
Routine and Special Processing of Human Tissue
Biorepository Science and the Effects of Long-Term Storage
Distribution of Biorepository Specimens to Investigators
The Importance of a Quality Management System
Education and Training
Annotation of Biorepository Specimens
Bias Affecting the Usefulness of Biorepository Specimens
Financial Management and Cost Recovery
Informatics in Biorepositories
Safety in Biorepositories

51. Regulatory Considerations for Research Biorepositories
Scott D Jewell, PhD, and Madeleine A Williams, MA
Terms and Definitions
Regulatory Considerations for Biorepositories
Responsibility for Data Handling by Biorepositories
Biorepository Structures

52. Current Ethical Issues in Biospecimen Research: Communicating Research
Information to Participants
Michele Russell-Einhorn, JD
Regulatory Background
Collecting the Research Specimens
Disclosing Results
Disclosure Expectations

Assessment and Characterization of Cellular Therapy Products
Section Editor: M Victor Lemas, PhD
Current State of the Field
Section Overview
Future Directions

53. Integrated Analysis of Hematopoietic Cellular Therapy Product Quality
Michael H Creer, MD, FCAP
Counting Cells in HCT Products
HCT Product Viability and Function
Indirect Viability Assessment Based on Dye Uptake and Staining
Direct Viability Assessment Based on Stem/Progenitor Cell Function
Effects of Time and Temperature on HPC(CB) Product Stability
Effect of Cryopreservation Freeze-Thaw Cycle on HPC(CB) Product Quality
Effects of Cryopreservation and Thawing on HSC Functional Assessment

54. Cell Counts and Differentials of Cellular Therapy Products
Carolyn A Keever-Taylor, PhD
HPC(M) and HPC(CB) Nucleated Cell Counts
HPC(M) Differentials
Apheresis HPC Products
HPC(A) WBC Counts
Mobilized Peripheral Blood Differentials
Sampling and Determination of Product Volume
Determination of Cell Numbers and CD34+ Cell Content in Thawed HPC(CB) Products
Instruments and Equipment

55. Assessment of Viability and Apoptosis in Cellular Therapy Products
Nicholas J Greco, PhD, and Lynn O’Donnell, PhD

56. Enumeration of CD34+ Cells by Flow Cytometry
D Robert Sutherland, MSc, and Michael Keeney, FIMLS, FCSMLS(D)
CD34+ Cell Enumeration Using Multiparameter Cytometry and Sequential Boolean
Gating: The International Society of Hematotherapy and Graft Engineering Protocol
Critical Issues in CD34+ Cell Enumeration

57. Colony-Forming Cell Assays for Determining Potency of Cellular Therapy Products
Emer Clarke, PhD

58. Bioluminescence Potency Measurement of Cellular Therapy Products
Holli Harper, MS, and Ivan N Rich, PhD
Criteria for Measurement of HSC Potency

59. Assessing the Function of Cellular Therapy Products by Measurement of
Cytoplasmic Aldehyde Dehydrogenase
Tracy Gentry, MT(ASCP), and Kevin Shoulars, PhD Background
ALDH br Cells: A Marker of Potency for Cord Blood

60. Cell Assessment and Characterization: Characterizing T-Cell Populations and Functions
Kimberly A Noonan, PhD, MPH, and Ivan Borrello, MD
Basic Principles of Flow Cytometry
An Introduction to T-Cell Biology
Phenotypic Analysis of T cells through Flow Cytometry
Functional Analysis of T Cells
Important Note: Specimen Procurement and Viability

61. HLA Typing for Cellular Product Characterization and Identity Testing
Terry O Harville, MD, PhD
HLA Discovery
Serologic, “Low-Resolution” HLA Typing
HLA Typing by DNA Analysis
HLA Nomenclature
HLA Typing by Molecular Techniques
High-Resolution HLA Typing by SSP-PCR Technique
HLA Typing by Sequence-Based Technology
Comparisons of DNA Typing
Next-Generation Sequencing Analysis
HLA Typing as an Identity Test

62. The Use of Blood Grouping for Identity Testing of Cellular Therapy Products
Ellen Areman, MS, SBB(ASCP)

63. Assessing Cellular Therapy Products for Microbial Contamination
John Duguid; Hanh Khuu, MD; and Gary C du Moulin, PhD, MPH
Special Challenges Pertaining to Sterility Testing of CT Products

64. Endotoxin Testing of Cellular Therapy Products
Diane Kadidlo, MT(ASCP)SBB

65. Detection of Mycoplasma Contamination
Peter Bugert, PhD
Common Characteristics of Mycoplasma Species
Methods for
Mycoplasma Detection
Mycoplasma Detection Based on Real-Time PCR
Future Directions of NAT-Based
Mycoplasma Detection

66. Pancreatic Islet Characterization
Elina Linetsky, PhD

67. Validation of Test Methods
Nina K Garlie, PhD
Performance Parameters
Appendix 67-1 Sample Validation Form

Method 9-1 Maintaining a Corrective and Preventive Action Program
Method 12-1 Selecting and Qualifying Equipment
Method 12-2 Equipment Management
Method 14-1 Internal Audits for the Cellular Therapy Facility
Method 19-1 Aseptic Technique for Cell Processing
Method 19-2 Operating and Maintaining the Biological Safety Cabinet
Method 27-1 Hematopoietic Progenitor Cell, Marrow [HPC(M)]
Collection, Processing and Preparation for Shipment
Method 28-1 Mononuclear Cell Apheresis Collection Using COBE Spectra
Method 28-2 Optia MNC Collection
Method 28-3 Stem Cell Collection with Terumo BCT Spectra Optia Using the cMNC
Program (software version 112) with the IDL Collection Set (Art-Nr 10310)
Method 29-1 Ex Utero Cord Blood Collection Procedure
Method 29-2 In Utero Collection of Cord Blood by the Carolinas Cord Blood Bank
Method 31-1 Reducing Plasma in Marrow and Hematopoietic Progenitor Cells from
Method 31-2 Separating Bone Marrow Buffy Coat by Using the COBE 2991
Method 31-3 HES Sedimentation for Manual Red Cell Removal
Method 31-4 Processing Marrow by Using the COBE Spectra for Mononuclear Cell
Method 31-5 Separating Marrow by the Density Gradient Method Using COBE 2991
Method 32-1 Processing Cord Blood with the PrepaCyte System
Method 32-2 Automated Processing of Umbilical Cord Blood with the Biosafe Sepax
System and Smart-Max Devices
Method 32-3 Automated Volume Reduction of Umbilical Cord Blood Using the
AutoXpress System
Method 32-4 Automated Processing of Umbilical Cord Blood with the SynGenX-1
Platform and Related Accessories
Method 33-1 Selecting CD34+ Cells by Using the Isolex 300i Magnetic Cell
Selection System
Method 33-2 Selecting CD34+ Cells by Using the CliniMACS System
Method 34-1 Counterflow Centrifugal Elutriation by Using a Floor-Model Centrifuge
Method 34-2 Monocyte Enrichment by Using the Elutra Cell Separation System
Method 35-1 Ex Vivo Expansion of Selected Hematopoietic Progenitor Cells from
Cord Blood
Method 36-1 Production of Umbilical Cord-Blood-Derived Regulatory T Cells
Method 37-1 Production of Peripheral-Blood-Derived, CD3-Depleted,
IL-2-Activated Natural Killer Cells
Method 39-1 General Overview of Current T Helper 2 Cell Manufacturing: Rapamycin-
Generated, Interleukin-4 Polarized Donor T Cells
Method 40-1 Isolating and Characterizing Mesenchymal Stem or Stromal Cells from
Method 40-2 Isolating and Characterizing Mesenchymal Stem or Stromal Cells from
Umbilical Cord Blood
Method 40-3 Isolating and Characterizing Mesenchymal Stem or Stromal Cells from
Adipose Tissue
Method 41-1 Culturing and Characterizing Human Dendritic Cell Vaccines
Method 42-1 Isolating Human Islet Cells
Method 42-2 Preparing Pancreatic Digestion Media: SERVA Enzyme Preparation
Method 42-3 Preparing Pancreatic Digestion Enzyme: Collagenase and Thermolysin
Method 43-1 Current Good Manufacturing Practice Production of Induced Pluripotent
Stem Cells from Human Dermal Fibroblasts
Method 45-1 Cryopreserving Cellular Therapy Products in Freezing Bags
Method 45-2 Automated Controlled-Rate Freezing, Storage, and Retrieval of
Volume-Reduced Cord Blood Units Using the BioArchive System
Method 47-1 Thawing of Hematopoietic Progenitor Cells: Laboratory and Bedside
Method 47-2 Filtration of Cellular Therapy Apheresis Products
Method 47-3 Infusion of Hematopoietic Progenitor Cells in Adult Patients
Method 47-4 Washing Cryopreserved Hematopoietic Progenitor Cells to Remove
Dimethyl Sulfoxide
Method 47-5 Washing Cellular Therapy Products Using the COBE 2991
Method 47-6 Reconstitutive Thawing: Preparing Frozen Cord Blood Products for Infusion
Method 49-1 Shipping Frozen Cord Blood Units
Method 54-1 Partial Plasma Removal from Marrow Samples
Method 54-2 Counting Nucleated Cells in Thawed Cell Therapy Products by
Using Single-Platform Flow Cytometry
Method 55-1 Determining Cellular Viability by Using Trypan Blue
Method 55-2 Determining Viability by Fluorescence Microscopy Using Acridine
Orange and Propidium Iodide
Method 55-3 Assessing Viability by Measuring Apoptotic Cells by Using Flow Cytometry
Method 56-1 Flow Cytometric Enumeration of CD34+ Hematopoietic Progenitor Cells
According to ISHAGE Protocol
Method 57-1 Hematopoietic Colony-Forming Cell Assays
Method 58-1 Measurement of Umbilical Cord Blood Stem Cell Potency
Method 59-1 Analyzing Aldehyde Dehydrogenase-Bright Cells in Umbilical Cord Blood
Segments to Assess Cord Blood Quality: Potency Assay Using a Thawed Cord Blood
Method 60-1 Simple Schematic for Processing Specimens for Immune Monitoring Studies
Materials, Reagents, and Equipment
Method 61-1 Microcytotoxic HLA Class I and Class II Serological Typing (Dynabeads-
Isolated Lymphocytes)
Method 61-2 LABType Reverse Single-Strand Oligonucleotide (rSSO) HLA TYPING
Method 61-3 High-Resolution Sequence-Specific Primer HLA Typing
Method 63-1 Cellular Therapy Product Sterility Testing (As Described in USP <71>)
Method 63-2 Cellular Therapy Product Sterility Testing Using an Automated Microbial
Detection System
Method 64-1 Kinetic-Chromogenic LAL Assay
Method 65-1
Mycoplasma Detection by Real-Time PCR
Method 66-1 Enumerating Pancreatic Islets by Dithizone Staining
Method 66-2 Determining Pancreatic Islet Function by Insulin Release
Method 67-1 Validating Test Methods



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Ellen M. Areman, MS, SBB(ASCP), and Kathy Loper, MHS, MT(ASCP)
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