We bring together expertise in stem cell research and banking to agree upon common standards of operation, from cell donor governance to shipment and delivery of stem cell lines both for research and clinical applications.
Strategy & Organisation
The ISCBI has developed a community of expert professionals in pluripotent stem cell banking which meets regularly to discuss and draw consensus on key issues for delivery of pluripotent stem cells for research, industrial and clinical application. It also invites additional expertise relevant to its workshop discussions, to help ensure an accurate reflection of international regulatory and ethical conditions.
Quality Control and the broader issues of Quality Assurance are fundamental aspects of the expertise operation of ISCBI participants who develop highly trained staff to deliver the minimum standards established through ISCBI consensus on scientific, technical and ethical matters.
The ISCBI sets minimum consensus standards on safety aspects of the use of stem cell focusing on development of safe pluripotent stem cell derived -therapeutics.
It also partners with other organisations such as the International Alliance for Biological Standardisation to support development of thought-leadership in stem cell-based regenerative medicines.
Training strategy is focused on:
Supporting the development of new stem cell biobanks
Promoting and engaging in training and educational activities
We establish opportunities to create international fora to discuss best practice delivery of pluripotent stem cell lines.
Key issues addressed by ISCBI include ethics, biobanking procedures, data management, safety testing, characterisation and quality assurance
Manufacturing Regulatory Issues
In the rapid expansion of the use of stem cell lines in diagnostics and therapeutics numerous issues have come to light. The ISCBI has provided a fertile ground for consideration of regulatory issues across a broad range of diagnostic testing and clinical products.