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UK makes validated stem cells available to therapy developers for £500 per vial

By Gareth MacDonald+

Last updated on 01-Mar-2017 at 10:55 GMT2017-03-01T10:55:08Z


Cell therapy developers can source “regulator ready” stem cells from the UK Stem Cell Bank (UKSCB) for a £500 per vial fee under a scheme announced by the MHRA.

The first batch of stem cells were available on Monday .

The UKSCB said because the cells are made in compliance with the European tissues and cells directive (EUTCD) they are suitable for use as starting materials in manufacturing therapies for clinical trials, adding that this would save developers time and money.

A spokesman told us “the supply process starts with application to the UK Steering Committee” adding that “once approval is given by the UKSC, and subject to signing the appropriate legal agreements with the Bank and the owner of the cell lines we would then supply the cells in  frozen vials.”

The current processing charge for frozen vials of the Research-Grade cell lines is £500 ($618) per vial” he continued.

Data dossier

At present the cell lines come with a Certificate of Analysis (CoA) which provides basic information, however, the UKSCB is working on more detailed data packages tailored to the specific needs of the user involved.

The spokesman said: “If the cells are intended as a starting material for cellular therapy or clinical trial we will be able to supply a cell line dossier which will aid in the regulatory approval process. This dossier is currently under development and will be available later in the year.”

He added that the data dossiers would be available for an additional charge, but did not provide details.

According to the MHRA the stems will be manufactured by researchers at the University of Sheffield, University of Manchester and King's College London.

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