Abstract
The human embryonic stem cell line RCe021-A (RC-17) was derived under quality assured compliance with UK regulation, European Union Directives and International guidance for tissue procurement, processing and storage according to Good Manufacturing Practice (GMP) standards. The cell line was derived from a day 3 embryo voluntarily donated as unsuitable or surplus to fertility requirements following informed consent. RCe021-A (RC-17) shows normal pluripotency marker expression and differentiation to the three germ layers in vitro. It has a normal 46XX female karyotype and microsatellite PCR identity, HLA and blood group typing data are available.
Highlights
RCe021-A (RC-17) was received as day 3 embryo that was surplus to requirement or unsuitable for clinical use and was cultivated to the blastocyst stage in medium containing Good Manufacturing Practice (GMP) grade granulocytemacrophage colony-stimulating factor (GM-CSF) to improve survival of the inner cell mass (Sjöblom et al, 1999)
Human embryonic stem cell isolation, expansion and qualification was performed in a facilities whose specification, operation and monitoring complied with GMP standards enabling; i) a fully traceable procurement procedure with informed ethical consent which includes provision for commercial use, ii) detailed medical history and blood borne virus (BBV)
HESC derivation was performed under licensure from the UK HFEA (R0136 to centre 0202) and Human Tissue Authority (HTA) (Licensing Number 22631)
Summary
RCe021-A (RC-17) was received as day 3 embryo that was surplus to requirement or unsuitable for clinical use and was cultivated to the blastocyst stage in medium containing GMP grade granulocytemacrophage colony-stimulating factor (GM-CSF) to improve survival of the inner cell mass (Sjöblom et al, 1999). Human embryonic stem cell (hESC) isolation, expansion and qualification was performed in a facilities whose specification, operation and monitoring complied with GMP standards enabling; i) a fully traceable procurement procedure with informed ethical consent which includes provision for commercial use, ii) detailed medical history and blood borne virus (BBV) Screening of donors, and iii) compilation of a cell line history providing details on hESC manufacturing process and quality control testing regime.
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