Glyn Stacey, Director of the UK Stem Cell Bank and Head of Cell Biology and Imaging at the UK’s National Institute for Biological Standards and Control, shared his views about the production of high quality cells for rapid drug discovery and clinical application at the World Stem Cells & Regenerative Medicine Congress last week.
Glyn began his presentation by considering the potential of human pluripotent human stem cells and the challenges of culture expansion, pluripotency (if, as Glyn suggested, cell lines can be so described) and differentiation.
In the early days, the Bank had experienced considerable variation in production rates.Â However, improving methodologies had since reduced variabilities, although some striking outliers persist.Â Potential solutions are being developed to address this lack of consistency between aliquots of bank/products.
Glyn described the basic protocols of cell banking for reliability: the original culture to pre-master culture, master culture and distribution,- with stringent quality control throughout.Â Identity, biomarkers, stability and microbiology assessment criteria for ensuring stem cell quality and control and safety were described. Turning to the “killer” issues for clinical grade cells (wrong cell line, viral contamination, gaps in document history, absence of informed consent), Glyn showed how the stem cell bank can provide significant risk reduction.
As regards tissue procurement and derivation, Glyn highlighted ethical issues, medical history, donor selection and risk factors association, among other matters, cell line derivation.Â In this regard, Glyn reminded delegates that the moniker, “GMP”, is no a guarantee of safety.Â The UK Stem Cell Bank measures clinical grade by comparison with the EU Tissue & CElls Directive (“EUTCD”).Â Once a “EUTCD grade” due diligence has been undertaken, the cells are not, of course, automatically suitable for the clinic (Glyn had once been asked whether such cells were available in injectable form!)Â Beyond EUTCD grading lie the release criteria, again described in detail.
In reviewing the distinct requirements for toxicology and drug discovery, Glyn Stacey observed that new protocols need to be developed for IPS cells, where there are specific scientific challenges.
Finally Glyn emphasised that the UK Stem Cell Bank is not an island. Taking international collaboration in therapy and product safety as essential to its function, the Bank has been a key participant in the international stem cell banking initiative (SCRR2009) working with StemÂ Cells for Safer Medicines and others.
Check back here in a couple of days for the full presentation. Excellent presentation Glyn!