Not Lost in Translation: Standards in cell therapy

by Alexey Bersenev on April 3, 2014 · 0 comments

in cell product, educational

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This is a sixth post of the series Not Lost in Translation.

If you’re trying to develop a cellular product and just entering the field of cell therapy, you should be aware of existent standards. Why is it important? Knowing standards in your field allows to:

  1. guide and accelerate product development
  2. meet expectations of regulators
  3. set high quality specifications

Even though, cell therapy filed relatively new, there are numerous related standards. Unfortunately, many professionals are unaware about organizations and standards in cell therapy field. The purpose of this post is to indicate few leadig organizations, providing standards and types of standards in cell products development. Significant part of this topic was summarized from the recent public FDA workshop – Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products.

Type of standards in cell therapy:

  • Consensus manufacturing standards (ISO, ASTM)
  • Pharmacopeial standards (USP)
  • Facility accreditation (AABB, FACT)
  • Labeling (ICCBBA)
  • Cell product development and characterization (ISCT, ARM)
  • Biological standards for translational research (GBSI, ATCC)

Standards-developing organizations and examples:
ISO – International Organization for Standardization
Developing and providing international standards, including medical devices, laboratory testing and some, related to cell therapy and tissue engineered products. Examples:
ISO/TC 194/SC 1 – Tissue product safety
ISO/TC 150/SC 7 Tissue-engineered medical products

ASTM International – American Society for Testing and Materials
ASTM – leading international standards organization. ASTM has Subcommittee F04.43 for developing standards in cell therapy and tissue engineering. Examples:
ASTM F2210 – Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products
ASTM F2739 – Standard Guide for Quantitating Cell Viability Within Biomaterial Scaffolds
ASTM F2315 – Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
ASTM F2944 – Standard Test Method for Automated Colony Forming Unit (CFU) Assays

USP – U.S. Pharmacopeial Convention
Provides standards for use ancillary and raw materials for cellular and tissue products. Examples:
Chapter 1046 – Cell and Gene Therapies Products
Chapter 1047 – Gene Therapy Products
Chapter 1043 – Ancillary Materials for Cell, Gene and Tissue-Engineered Products
Chapter 92 – Growth Factors and Cytokines Used in Cell Therapy Manufacturing
Chapter 90 – Fetal Bovine Serum—Quality Attributes and Functionality Tests

GBSI – Global Biological Standard Institute
Developing standards for life sciences, including biomedical research.

ATCC – American Type Culture Collection
Manufactures and provides reference material (including cells), developing biological standards for basic and translational research. Examples:
ATCC Certified reference material
ATCC Standards Development Organization

BSI – British Standards Institution
Has a project for developing regenerative medicine definitions and guidelines for clinical cell products characterization. Examples:
PAS 93:2011 Characterization of human cells for clinical applications. Guide
PAS 84:2012 Cell therapy and regenerative medicine. Glossary

FACT – Foundation for the Accreditation of Cellular Therapy
Provides standards for collection and processing cellular products. Accredits clinical “stem cell labs”, cord blood banks and “more than minimal manipulation” cell therapy facilities. Examples:
FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration
FACT-JACIE Cellular Therapy Accreditation Manual

AABB – American Association of Blood Banks – Center for Cellular Therapies
In cell therapy field, AABB has very similar functions with FACT. Examples:
Standards for Cellular Therapy Services

ICCBBA – International Council for Commonality in Blood Bank Automation
Management of the ISBT-128 Standard – “the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, and organ products)”.

ISCT – International Society for Cellular Therapy
ISCT leverages expertise of cell therapy professionals to develop guidelines and recommendations for cellular products development, characterization, and quality. Examples:
Minimal criteria for defining multipotent mesenchymal stromal cells
Potency assay development for cellular therapy products
Stromal cells from the adipose tissue-derived stromal vascular fraction and culture expanded adipose tissue-derived stromal/stem cells – IFATS/ISCT statement

Coordination and harmonization
As you can see, there are many organizations, involved in different aspects of cell therapy standardization. How can we make sure that there are no overlaps between them? How to coordinate and harmonize their activities? There are some good existent examples of such coordination:

This post is a part of Not Lost in Translation online community project. In this series we will try to bridge the translational gaps between scientific discovery in research labs and clinical cell applications for therapies. We will look at challenges in translation of cell product development and manufacturing in academic and industry settings. If you would like to contribute to this community project, please contact us!

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