Delivering a mature banking and distribution operation
The ability of EBiSC to bank and distribute cell lines to satisfy user requests will be underpinned by the project reaching a number of key milestones as the operations are put in place.
Initially the project partnership established many routine procedures for collecting, expanding and characterising cell lines. This was essential in preparation for banking and likewise procedures for shipping, tracking and recovery of cell lines are being validated as part of the distribution functions. Established, authentic iPSC lines made from normal consenting donors, have been pivotal in validating many of these standard procedures.
Distribution of cell lines between project partners, in particular to EFPIA participants in EBiSC, is ongoing and future integrity testing of bioengineering solutions and the information management system is planned. Distribution of existing cell lines from the Hot Start collection is useful for helping the project identify proposed procedures that require further optimisation.
A gap analysis to assess what is existing and accessible and what is needed currently by users has identified new opportunities for iPSC line creation. New line commissioning using the validated, standard procedures has been initiated ahead of planned schedule to meet demand. This reactive mode in broadening the EBiSC Foundational Collection, to include many new disease representative and control lines for research will represent a major distinctive feature for the eventual EBiSC catalogue.
The following four key components will come together in support of the development of mature banking and distribution activities.
- The design and implementation of bioengineering and quality control testing technologies will lead to eventual cost reductions, while increasing operational scale.
- Users will access far greater data than provided by other cell banks, on individual iPSC lines in the catalogue via the bespoke information management system.
- Harmonisation of standards, policies, procedures and legal instruments, based on increased understanding of stakeholder interests and user needs will be implemented.
- Finally the strategic trajectory of the EBiSC banking and distribution operation will be mapped out in preparation for reaching self-sustainability. This will include a plan as to how it will collaborate with other iPSC global projects based on overlapping interests and also identify unique EBiSC propositions.
Overall these components will be integral to mainstream EBiSC operations so that before the end of the project EBiSC will have demonstrated the capacity to operate a mature operation for which all of the major infrastructure and related technology development will have been completed.