It is good to see new cleanroom builds populating the news in Cleanroom Technology once again. Europe has seen reduced facility investment in recent times but the UK is at last witnessing a resurgence in new builds. Much of the investment is being driven by biotechnology and cell-based therapies. Every week breakthrough stem cell treatments for previously untreatable medical conditions are heralded in the press.
The £55m cell therapy manufacturing centre in Stevenage, UK, due to open in 2017, is an example of a facility for the manufacture of late phase clinical trial and commercial supply of cell and gene therapies. Meanwhile in Scotland, TC BioPharm’s new clinical manufacturing facility in Glasgow, for processing immune cells, has also been granted a licence by the UK Medicines and Healthcare products Regulatory Agency to produce human cell therapy products.
In December, the European Medicines Agency approved Holoclar, a treatment in which a patient’s healthy stem cells are used to grow new cells that are then transplanted into the eye. In the US at least eight cell therapy products have received approval since 2009.
Such technologies not only require highly controlled manufacturing environments to ensure the quality of cells, but they also need specialised cryopreservation facilities. Lives have already been lost due to failings in the way in which stem cells used in life-saving operations were frozen by hospitals.
Contamination control is not only key in terms of providing barriers to contaminants from the external environment and operators during manufacture but also in preventing the accidental mixing of cell samples or contamination from processing aids, reagents, growth media and even existing cultured cell lines.
I hope to see many articles in future about how these challenges can be overcome, if only to ensure that we do not see a recurrence of the ‘contaminated blood scandal’ that has affected haemophiliacs and others around Europe since the 1970s.