Cellular Therapies Subsections Projects

The Cord Blood Subsection develops resource materials that address a variety of issues related to this cell source.

Learning Tools

COVID-19 - Primary Information Sources (PDF)
Umbilical Cord Blood Collection

Presentations

How Do You Monitor All Your Cell Therapy Products and Reagents? (PDF)
History of Cord Blood Banking (PDF)
BACTEC FX Validation (PDF)
mRNA COVID Vaccines and COVID-19 Primer (PDF)
Oxygen Deprivation Hazards in the Lab (PDF)
Effect of COVID-19 on Cord Blood Banking (PDF)
Corona Virus COVID-19 Description and Considerations (PDF)
Timing of CB Clamping - Its Impact on CB Collection (PDF)

The APG discusses topics and develops projects relevant to many of the subsection areas with emphasis on cord blood issues and potentially unique regional challenges.

Presentations

Cord Blood Banking in Abu Dhabi - An Overview (PDF)
Good Manufacturing Practice in Cell and Gene Therapy (PDF)
Onboarding New Projects - Clinical Trials (PDF)
Pancreatic Islet Transplantation - Recent Advances (PDF)
The Professionalization of Mesenchymal Stem Cells (PDF)
ISBT 128 Chain of Identity Identifier (PDF)
Cellular Therapy in Sudan - Achievement and Challenges (PDF)
Critical Supply Shortages in CT - A Roadmap for Fulfilling Standards (PDF)
Identifying a Safe and Effective Dose of Umbilical Cord-Derived MSCs for the Treatment of MS (PDF)
Regulatory Consideration in Cell Therapy Product Manufacturing (PDF)
Standardization Strategies in Flow Cytometry (PDF)
Blood and Marrow Collection Program Overview (PDF)
Hematopoietic Stem and Progenitor Cell (HSPC) Stability (PDF)
Bone & Marrow Collection Program at Georgetown University Hospital (PDF)
Quality Assessments in CT - Risk, Validation and More (PDF)
A Little About the Australian Red Cross (PDF)
Stability Program Survey Report- Draft Recommendations- Joint AABB-ISCT Work Group (PDF)
Challenges-Experience with Convalescent Plasma Therapy & Transfusion Practices During COVID-19 Pandemic (PDF)
Validation of Automated Microbial Cultures in the CT Lab: Things that You Need to Know (PDF)
Regulations and AABB Standards Update (PDF)
Graft Manipulation in ABO Incompatible PBSC Transplant (PDF)
AABB Virtual Audits and Audit Preparedness (PDF)
Most Common Non-Conformances Seen Internationally from an Assessor’s Perspective (PDF)
Preparedness During Audits and Planning a Calendar for Internal Audits (PDF)
Stem Cell Tourism - An Overview (PDF)
Common CT Non-Conformances For Facilities in the Asia-Pacific Region (PDF)
Priorities for Testing COVID-19 Patients (PDF)
Use PPE When Caring for Patients with COVID-19 (PDF)
Regulation of Cell and Gene Therapy Products (PDF)
GMP Production of Pluripotent Stem Cell-Derived Therapeutics (PDF)
Building a New Processing Facility (PDF)
Therapeutic Neovascularization With Cell Transplantation - Limb-Cardiac Ischemia (PDF)
Clinical Trials: Moving Cell-Based Therapies to the Clinic (PDF)
ISBT 128: Overview and Implementation for Cellular Therapy (PDF)
How to Set Up a New Stem Cell Processing Laboratory (PDF)
Advances in Gene Therapy and Considerations for Blood Centers (PDF)
Adoptive Immunotherapy (PDF)
Clinical Translational of Vascular Niche for Hematopoietic Stem Cell Expansion and Transplant (PDF)

This subsection addresses topics surrounding the development and processing of cellular therapies including collection of cells from a variety of sources, manufacturing, testing, and strategies used in novel therapies and clinical practices.

Evaluation Tools

The resources listed below are intended as points to consider in evaluation of products and supplies in a systematic manner:
Validation Sample SOP (PDF)

Presentations

Sampling of presentations from invited experts:
Microfluidic Blood Cell Sorting Applied to the CAR T Cell Field (PDF)
Cryopreservation - Insights into Challenges of Product Storage (PDF)
Changes in Environmental Monitoring ISO Standards for Cell and Gene Therapies (PDF)
FDA Laboratory Developed Tests Proposed Rule (PDF)
Basic Principles of Aseptic Technique (PDF)
Flow Cytometry- Critical Role in SCT and CT Laboratories (PDF)
Beyond CAR-T...CAR-NK Cells (PDF)
Cryopreservation and Post Thaw Methods (PDF)
Unproven Stem Cell Therapies and Stem Cell Tourism (PDF)
Crossmatch Pre-Transplant in Pts with Specific Anti-HLA Abs (PDF)
Challenges in Cellular Therapy Manufacturing (PDF)
Biopreservation-Stability in Clinical Workflow (PDF)
MSC for COVID Pneumonia - A Case Study (PDF)
cGMP Manufacturing for Cell Therapy (PDF)
Stem Cell Tourism (PDF)
Importance of Logistics in Cell Therapy Manufacturing (PDF)
Hematopoietic Chimerism - Present-Future Methods and Applications (PDF)
Implementation of Immune Effector Cell Therapy in Canada (PDF)
Stem Cells for Corneal Wound Healing (PDF)
Process Development Considerations for Cryopreservation of Cellular Therapies (PDF)
CT Translational Regenerative Rehabilitation Therapies (PDF)
Development - Validation of Rapid ALDH Bright-Based CB Potency Assay (PDF)
Human Platelet Lysate - Potential Uses (PDF)

Publications

Several members have published articles based on CT subsection activities:
Transfusion Practices for Bone Marrow Harvests: A Survey Analysis from the AABB Bone Marrow Quality Improvement Initiative Working Group
Use of Laboratory Tests to Guide Initiation of Autologous Hematopoietic Progenitor Cell Collection by Apheresis: Results from the Multicenter Hematopoietic Progenitor Cell Collection by Apheresis Laboratory Trigger Survey

This subsection addresses regulatory issues, Guidance documents, quality program design, risk management, vendor and supply qualification, facility, environmental operational controls and how good management principles support these activities.

Presentations

Sampling of presentations from invited experts:
Ethics in Publishing (PDF)
Design and Change Controls (PDF)
10ed Standards for Cellular Therapy Services - Most Cited Non-Conformances (PDF)
FDA Assessment Review - Questions About Lab Assessments (PDF)
CBER Strategic Plan - Extracted Highlights (PDF)
Lookbacks That May Not Identify All Those At Risk (PDF)
Blood Center Considerations for Product Collections, Processing and Distribution (PDF)

Management Tools

Service Level Agreement (PDF)

The Spanish Language Subsection develops resource materials in Spanish that address cellular therapy issues.

Presentations

Acreditación AABB - Bancos de Sangre y Servicios Transfusionales (PDF)
Validaciones de Vuelta a lo Basico (PDF)
Trasplante de Células Progenitoras Hematopoyéticas (PDF)
Validacion of Cultivos Microbianos Automatizados en el LTC (PDF)
HCTP Regulations (PDF)
Sangre de Cordón- Utilizando en Experienza (PDF)
Experiencia Chilena en el Almacenamiento de Sangre (PDF)
Experiencias de un Banco de Sangre de Cordón (PDF)
HSC Transplants in the Hispanic Community (PDF)
Herramienta de Auditoría ISBT 128 para Terapia Celular (PDF)

The AABB CT subsections have hosted a variety of speakers on their monthly calls. Several of their presentations have been captured on videos. Click on the links to view the full presentations.

This material was prepared for presentation by the author. It is not intended to be all inclusive, relied upon as legal advice, representative of any specific business need or product, or to guide, direct or advise staff or procedures, or to be used for any other purpose. AABB expressly disclaims any liability for any damage or loss that may arise from relying upon or using information contained in this presentation.

Acreditación AABB - Bancos de Sangre y Servicios Transfusionales (Spanish)
Insights into Good Manufacturing Practice (GMP) for Cell and Gene Therapy
ISBT 128 Chain of Identity (COI) Identifier
Basic Principles of Aseptic Technique
AABB-ISCT Joint WG Stability Program (DRAFT) Recommendations
Trasplante de Células Progenitoras Hematopoyéticas (Spanish)
Looking at Workload in Cell Therapy Processing Labs
Critical Role of Flow Cytometry in Stem Cell Transplantation and Cellular Therapy Laboratories
Validation of Automated Microbial Cultures in the CT Lab
Validacion of Cultivos Microbianos Automatizados en el LTC (Spanish)