April 17, 2020
CAR-T: Promising therapy with lots of potential – but there are still hurdles to take!Reading time: 3 minutes
Standstill is a concept unknown in the field of medical research. Quite to the contrary, scientists are constantly developing new medications and therapies against cancer and other life-threatening illnesses. One such therapy is the so-called CAR-T therapy.
The use of CAR-T cells has been researched since the late 1980s with the aim to genetically change the patient’s T-cells so they recognize and attack cancer cells. A sample of T-cells is collected from the patient’s blood, then modified to grow large numbers of a special structure called chimeric antigen receptors (CARs) on their surface.
Once they are infused back into the patient’s blood, the new receptors enable the cells to latch onto a specific antigen on the patient’s tumor cells and kill them.
Elaborate and costly therapy with promising results
This short summary describes an elaborate and costly process that, however, is promising. In 2010, the new therapy was successfully applied for the first time: It is scientifically proven that two patients suffering from chronic lymphocytic leukemia (CLL) could be cured.
Currently, five severe illnesses can be treated with the CAR-T cell therapy. 300 further applications – more than 100 of which are aimed against various tumor diseases – are being developed at present. While the individual therapy is promising, it poses its own challenges. The elaborate manufacturing procedure is costly, and the slightest supply chain flaw can render modified immune cells ineffective and useless.
As a result, the seemingly banal logistics process is one of the biggest challenges. But so far, the pharmaceutical industry is used to producing and shipping vast amounts of valuable drug substance and there are no agile solutions for small batches.
The pharma industry is dependent on reliable logistics processes
The long-distance shipment of valuable high-quality substances is part of the biopharmaceutical industry’s daily business. 1 to 3 % of all therapies are usually rendered useless due to contamination during shipping or other forms of loss of drug substance. This entails financial losses, but, more importantly, it can compromise life-sustaining measures.
A reliable logistics process in the biopharmaceutical industry is essential in order to not jeopardize the success of treatments like the CAR-T cell therapy. This not only encompasses the protection of the shipped goods but also their adequate and protected storage.
Single use platform for a monitored and scalable freeze-thaw process – CAR-T cell therapy
Traditional systems have mostly been designed for the production of blockbusters. The as-of-yet low volume of CAR-T cell therapies equals increased costs, which constitutes yet another challenge.
This is where SUSupport comes in: Like their counterparts in the medical research field, the scientists here are constantly working at developing improved reliable and – above all – scalable solutions. Based on the fact that the devil is usually in the detail, the team at SUSupport have designed a product that can be used in various settings, thus counteracting a true bottleneck – the bottleneck, in this case, being a reliable and scalable logistics process.
RoSS.pFTU lab scale for minimum quantities of drug substance – the advantage for CAR-T cell therapy
Based on the use of single use bags and single-use technologies, SUSupport has developed a platform that is both scalable and compatible with single use bags from any established manufacturer and size – and it covers the entire logistics process for the biopharmaceutical industry.
The automated filling of various batch sizes takes just a few minutes. This is a clear advantage for therapies like the CAR-T cell therapy that are still in their early stages. RoSS.pFTU lab scale is the perfect platform for clinical studies and guarantees a monitored and scalable freeze-thaw process even for small volumes.
With RoSS.pFTU lab scale, quantities as miniscule as 1 to 5 ml can be filled into single use bags prior to being frozen accurately in a monitored process. A specially developed sleeve made of stainless steel and 3D foam called RoSS shell guarantees for a reliable and protected transport – while the foam encapsulates the single use bag with its valuable content, the stainless-steel sleeve protects it from external shocks and damages. The content is safe from biocontamination and will arrive unharmed at its final destination.