April 22, 2020
CAR-T: A promising therapy and its challengesReading time: 3 minutes
Scientists have been working on the so-called CAR-T cell therapy since the late 1980s. Cells are extracted from the patient’s blood to then be manipulated in the lab so they recognize and attack cancer cells. This type of individual therapy has been successfully applied for the first time in 2010.
It has been approved in the US and the European Union and is currently available under various names for the treatment of different forms of leukemia. While first successes are undeniable, the experts are constantly developing and testing new compounds.
New CAR-T cell constructs are used in clinical studies to test a broader approach for a wider range of oncological treatments. The genetically modified cells are usually produced in-house at the study centers’ labs before being tested on patients who would usually not qualify for commercially approved CAR-T therapies.
Other than with already certified compounds and therapies clinical trials mostly require only insignificantly small volumes of drug substances. But nonetheless these have to be stored and shipped carefully. Diligent handling is imperative, and the sensitive matter does not allow for any glitches – neither during the production process in the lab nor on the final product’s way to the patient.
Speed and a reliable shipping process are paramount, especially in the CAR-T cell therapy
The logistics process has always played a crucial role in the pharmaceutical industry. But while the process itself and the supply chain are usually geared towards the handling of large volumes, more and more small volumes need to be shipped in a reliable and monitored manner.
International cooperation in research as well as in clinical trials is on the rise, thus calling for swift and dependable transport of minimal volumes of drug substance, either from one lab to the next across town or around the globe.
In such cases, a faulty single use bag can have fatal consequences. Speed plays another role in order for the solution not to lose its efficiency and effect. Consequently, timing is of the essence – not only during shipping, but also during filtering, filling, freezing and packaging.
CAR-T cell therapy – There are no second chances for life-sustaining measures
Delays and biocontamination caused by leaking or faulty single use bags can render an entire batch of highly valuable drug substance ineffective, causing substantial financial losses but also endangering patients’ lives. And when it’s a matter of death or life, second chances don’t stand a chance.
In order to not jeopardize the outcome of established and newly developed medical therapies, an absolutely reliable logistics process and automated processes are crucial – this includes storage and shipping. Sterility is essential and at times this may call for the filtration of medical substances during the filling process.
Versatile, scalable and monitored: one platform for the entire logistics process – ideal for CAR-T cell therapy
The Austrian company SUSupport with its headquarters in the Tyrolean Alps has set itself the goal to address the potential bottlenecks of the pharmaceutical logistics process and to offer solutions. Their focus is on the compatibility and scalability of new technologies and platforms.
As opposed to traditional systems that are usually designed to handle large volumes of blockbusters, all of SUSupport’s innovative systems are scalable. They can be utilized for miniscule volumes in the lab as well as for trial purposes. Furthermore, they can be equipped with filters as needed.
Their platform RoSS.pFTU lab scale handles the entire logistics process for pharmaceutical substance, no matter if it is required in small volumes for studies or in bulk for the manufacturing of approved compounds.
RoSS.pFTU is compatible with single use bags of all established brands and allows for an automated and monitored freeze-thaw-process that only takes a few minutes. The RoSS.FILL is another system that stands out thanks to its versatility, and it can be used with or without filters.
Volumes as small as 5 ml can be filled into single use bags with the RoSS.pFTU lab scale. The RoSS shell made of 3D foam and stainless steel has been specifically developed for the use with this platform and guarantees for a secure transport of the frozen goods. It offers stability and protects the bag’s valuable content from biocontamination – no matter the volume.