Wednesday, 21 October 2015

Cell Therapy Catapult of regulatory requirements


U.K. MHRA advises the Cell Therapy Catapult of regulatory requirements:

In 2012, the Cell Therapy Catapult was established by Innovate UK as a centre of excellence for innovation, with a view to developing a world-leading cell and gene therapy industry in the UK. Their mission is to drive the growth of the industry by helping cell and gene therapy organisations around the world to translate their early-stage research into commercially viable therapies.

One exciting new development is the advent of induced pluripotent stem cells (iPS) for use in new therapeutic products. iPS cells are developed by taking specialised adult dividing cells (e.g. skin cells) and ‘reprogramming’ them back to stem cells. These stem cells are considered to be ‘pluripotent’, meaning that they can be used to make any type of cell in the body.

In late 2013, the Cell Therapy Catapult partnered with Roslin Cells to establish a source of clinical grade iPS cells banked according to good manufacturing practice (GMP) in the UK, which can be used to accelerate the growth of the industry, specifically the progression of iPS based therapies into clinical trial.

It is expected that this emerging technology will significantly progress the sector in the UK, as unique challenges are overcome. For example, in scoping the project it became clear that important quality and regulatory issues would need to be expertly addressed in order to maximise the utility of the bank worldwide.

For further details see: MHRA

Posted by Tim Sandle