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Lack of qualified labor is another major bottleneck that could stop CGT from taking off. Cell processing, washing and feeding are complex and often repetitive processes involved in CGT therapies that require highly qualified workers. For example, a form of CGT called autologous therapy uses a patient’s own cells. It often requires weeks of work by multiple workers in a dedicated infrastructure. Plus, the operators, once recruited, may need additional training for a long period to attain the required expertise.
In 2018, the CGT Catapult launched The Advanced Therapies Apprenticeship Community with the support of the UK government. It is the first apprenticeship program designed to specifically train people in developing, manufacturing and delivering CGTs.
Despite the various factors that could limit the market, the outlook is still incredibly optimistic. Growing advancements in CGT technologies like the development of off-the-shelf products and application of advanced gene-editing techniques such as CRISPR will lower the complexities involved in manufacturing CGTs. This should help bring costs down and also address the skills gap issue.
CRISPR (clustered regularly interspaced short palindromic repeats) technology: CRISPR/Cas9 is a gene-editing tool technology with significant application in the CGT area. It can disrupt a disease-causing gene or correct and insert new genetic material. It has applications in drug discoveries and can help develop therapeutics for cancer, rare genetic diseases, infectious diseases and other conditions. The current approved CAR-T therapies are limited to only liquid tumors. However, companies are working towards developing CAR-T therapies for solid tumors using CRISPR technology.
Off-the-shelf solutions: Immunotherapies such as CAR-T therapies are personalized therapies that involve the collection of T-cells from patients (autologous) that makes the process complex. Most of the time, patients may have undergone multiple therapies such as chemotherapy previously and may have compromised immunity. To minimize the risks associated with autologous therapies, researchers are currently focusing on developing therapies using health donors that can be delivered as off-the-shelf products.
Companies such as Allogene Therapeutics are working on off-the-shelf CAR T-cell therapies using T-cells from healthy donors. This approach mainly helps companies minimize pricing issues with CGTs. It also makes these therapies readily available with improved potency and improves patient access and affordability.
The CGT market is growing rapidly. Clinical trials are increasing in numbers, stakeholders are upping investments, and personalized medicine for rare and chronic conditions is receiving a sharper focus. Having access to the full picture is vital for anybody operating within the industry.
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