- By Claudia Jarrett
- June 11, 2020
This article discusses how automating cell and gene therapies will bring the treatment to the masses.
Cell and gene therapies are two overlapping fields of biomedical research that mark a seismic shift from the traditional, one-treatment-fits-all approach to a new era of more personalised, targeted medicine.
Breakthrough technologyRespectively, cell and gene therapies are the use of cells or genes to treat diseases. In gene therapy, healthy, or wild type, copies of a gene may be added to cells to replace mutated ones, malfunctioning genes may be inactivated, or a new gene introduced to the body to help fight disease.
Cell therapy uses cells, often stem cells, to replace missing or diseased cells in the patient’s body. Sometimes cells are removed from the body, treated with gene therapy, then replaced — hence the overlap between the two areas.
Numerous clinical trials have shown that cell and gene therapies have the potential to treat diseases and disorders that are currently incurable, including cancer, haemophilia and sickle-cell disease.
From 2020 onwards, the Food and Drug Administration (FDA) expects to receive more than 200 investigational new drug applications for cell and gene therapies each year. By 2025, it forecasts approving ten to 20 therapy products a year.
Scaling upAs more and more therapies are approved for use, the challenge is to scale up the manufacturing process for cell and gene therapies, from experimental research to industrial production, by increasing the efficiency of production and the number of manufacturing facilities across the US. To achieve this, cutting-edge industrial equipment will be needed.
Currently, manufacturing cell and gene therapies relies heavily on manual processes. These are costly, labor intensive and depend on the expertise and judgement of whoever carries them out. As a result, there is a high risk of human error, variability between batches, contamination and batch loss.
Automating the process solves many of these issues. In such a complex biological product, even the slightest variation in its development can have an impact on the quality of the final result.
To deliver greater control and accuracy, complex automation solutions such as robotic arms can repeat actions with consistent speed, force and accuracy, dramatically increasing process reliability and reproducibility. However, the added complexity also brings risk of failure, obsolescence and costly downtime. EU Automation’s experience working with the pharmaceutical and biomedical industries means we know failure is not an option, and guarantee record delivery times for components when disaster strikes.
Furthermore, fully automating the manufacture of cell and gene therapy products in a closed system mitigates the risk of human error and contamination completely, eliminating human contact and rendering clean rooms obsolete.
To produce cell and gene therapies quality and safety are essential, both in the finished product and the machinery used to manufacture it. EU Automation only works with trusted, leading automation suppliers to ensure that all the components we supply meet the highest standards.
Most importantly, automating cell and gene therapy production will enable the kind of scale-up necessary to make these therapies commercially viable. This will, in turn, facilitate regulatory compliance and allow these therapies to treat the patients who need them.
In the 17 years since the human genome was first mapped, the biomedical industry has developed numerous landmark technologies, of which cell and gene therapy are just two of many. In the next 17 years, the automated manufacture of cell and gene therapies will hopefully have brought this experimental technology to the masses, saving countless lives in the process.
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