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Centre for Stem Cell Biology - University of Sheffield

Dr. Zoë Hewitt

As Quality Assurance Manager of the Centre for Stem Cell Biology, Stem Cell Derivation Facility I am responsible for ensuring the quality and safety of human embryonic stem cells (hESCs) derived as raw materials for secondary clinical manufacture.

I have six years of experience culturing hESCs, including a period of time developing differentiation protocols for hESCs to Hepatocytes, and 12 months experience of quality management.  It is anticipated that following the production of a suitable grade hESC line as a raw material I will be able to use these expertise to assist the Research Scientists involved in the London Project to develop their differentiation procedures for RPE cells inline with Good Manufacturing Practices (GMP).

Key achievements

The development of a Quality Management System which has been independently audited and considered to be of a high standard

Invited to speak at conferences on issues relating to developing quality management systems and deriving clinical grade human embryonic stem cells

Member of a National Quality Forum, dedicated to defining Quality and Safety Criteria for hESC raw materials

Part of a working group involved in defining the regulatory framework of hESC raw materials within the UK

Key publications

  • Zhao, D. Hay, D.C., Fletcher, J., Hewitt, Z.A., McLean, D., Black, J.R., Urruticoechea-Uriguen, A., Elcombe, C., Ross, J.A. Wolf, C.R. and Cui, W.  Efficient Differentiation of Hepatocytes from Human Embryonic Stem Cells Exhibiting Markers Recapitulating Liver Development In Vivo. (In Press)
  • Hewitt, Z.A., Amps, K.J. and Moore, H.D.  Derivation of GMP Raw Materials for Use in Regenerative Medicine: hESC-based Therapies, Progress Toward Clinical Application. Clinical Pharmacology & Therapeutics 2007 Oct; 82(4):448-52.
  • Hewitt, Z., Priddle, H., Thomson, A., McWhir, J.  Ablation of undifferentiated human embryonic stem cells: exploiting innate immunity against the Gal α1-3Galβ1-4GlcNAc-R (α-gal) epitope. Stem Cells. 2007 Jan;25(1):10-8.
  • Hewitt, Z., Forsyth, N., Waterfall, M., Wojtacha, D., Thomson, A.J. & McWhir, J.  Fluorescence Activated cell Sorting of Human Embryonic Stem Cells. Cloning and Stem Cells. Sep 2006, Vol. 8, No. 3 : 225-234.