Quality control in hiPSC lines banking and Registry of hiPSC
Working group 3 shall identify optimal systems for safety-assured and reliable cell therapies to promote standardization of hiPSC scaling and banking for basic and clinical researchers and regulators. Based on the existing European human Pluripotent Stem Cell Registry (hPSCreg), the team of experts shall define the hiPSC-associated data to be collected and develop a data resource, access platform and registry for available hiPSC lines suitable for the manufacture of therapeutic products.
Objectives
- Identification of optimal systems for safety-assured and reliable cell therapies to promote standardisation of hiPSC scaling and banking for basic and clinical researchers and regulators.
- Development of a data resource and access platform and registry for available hiPSC lines suitable for the manufacture of therapeutic products based on the existing European human Pluripotent Stem Cell Registry (hPSCreg).
- Definition of hiPSC -associated data including origin, characterization and usage and linkage to existing repositories; provision of a source overview for donor material in CB via a single portal.
- Establish core requirements for evaluation of suitability of hiPSC in terms of differentiation potential and elimination of reprogramming vectors.
- Standardisation of hiPSC characterisation for basic and clinical researchers and regulators.
WG3 Leaders
Andreas Kurtz
Description of Work
T3.1
Literature review on quality control for hiPSC for the manufacture cell therapy products and meeting with product developers and regulators to identify recommended standards to be used for hiPSC production and biobanking.
T3.2
Workshop to review Task 3.1 output and agree quality, safety and standards guideline document including scientific, technological and regulatory challenges for Biobanking.
T3.3
Registry implementation: literature review on international management of data, data standards and output involving data experts and map optimal route for stem data interoperability and registration. Incorporation into the hPSCreg.
Deliverables and milestones
D3.1
Guidelines and standards road-map document and quality manual for hiPSC biobanking.
D3.2
Report of database for inclusion into European human Pluripotent Stem Cell Registry (hPSCreg).
M3.1
Establish standards required for production and biobanking of hiPSC for the manufacture of products for cell therapy.
M3.2
Selection of hiPSC line data to be collected.