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Setting Up a Haplobank: Issues and Solutions
Jacqueline Barry1, Johan Hyllner2, Glyn Stacey3
1Cell Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London, SE1 9RT UK.
Current Stem Cell Reports
|July 31, 2015
Summary
Induced pluripotent stem cells (iPSCs) enable scalable regenerative medicine therapies. Establishing a global iPSC haplobank requires international collaboration on manufacturing standards to prevent fragmented development.
Area of Science:
- Regenerative Medicine
- Immunology
- Biotechnology
Background:
- Induced pluripotent stem cells (iPSCs) present a scalable manufacturing solution for regenerative medicine.
- Donor selection based on human leukocyte antigen (HLA) systems can minimize immunological rejection and reduce the need for immune suppression.
- Broad availability of iPSC lines necessitates international agreement on common standards.
Approach:
- The development of a global Good Manufacturing Practice (GMP) iPSC haplobank is proposed.
- International collaboration is essential for defining optimal HLA panels, donor selection, screening, consent, GMP, quality control, and regulatory frameworks.
Key Points:
- Scalable cellular therapies for regenerative medicine.
- Minimizing immune rejection through HLA matching.
- Need for global standards in GMP iPSC manufacture.
- Addressing challenges in establishing a global iPSC haplobank.
Conclusions:
- International agreement on common standards for GMP iPSC manufacture is urgently needed.
- Proactive collaboration can prevent fragmented development in the iPSC field.
- A global iPSC haplobank can advance regenerative medicine therapies worldwide.
