Editing a broad sector magazine such as Cleanroom Technology requires the rapid assimilation and understanding of new industrial and market-led technologies and it seems to me that, over the past 10 years, that pace of change has increased exponentially in some sectors.
One such area is regenerative medicine. While stem cell technology seemed but a twinkle in researchers’ eyes 20 years ago, stem cell therapies have become a reality.
The technology progressed greatly in 2006 with the introduction of induced pluripotent stem cells (iPSC) – adult cells that are isolated and then transformed into embryonic-like stem cells through the manipulation of gene expression and other methods. Today we are faced with the real possibility of therapies for various debilitating diseases being offered to patients, as some of the clinical trials currently underway promise remarkable success.
The global biotech and pharmaceutical industries, meanwhile, have been debating how to scale up the production of the cells that will be needed in massive quantities. New stem cell producing facilities are springing up with great regularity, and many more are in the planning stages.
It is an unfortunate reality, however, that the therapies often holding the most potential also carry numerous issues regarding their safety, and contamination is a major concern for those manufacturing cell lines. Stem cells are not always ‘pure’ because their exposure to other animal cells to maintain their viability can result in contamination. Many animal cells contain microscopic microbes and diseases that are undetectable and contaminate human embryonic stem cells that could be passed on to the patient.
In addition, in spite of the utilisation of sterile techniques during collection and processing of these products, contamination can occur from many sources. This is clearly where the contamination control sector can look forward to playing its part in helping the promising stem cell treatments become routine and regular therapies for serious disease.
