While the logistics process has always played a vital role in the manufacturing of approved medical compounds and pharmaceutical blockbusters, it is becoming ever more important in the scope of clinical studies.
Logistics do not only cover the safe and reliable transport of high-quality drug substances but also include filtration, filling and the entire freeze-thaw-process, the latter of which takes on an essential part in the manufacturing of medical compounds.
The drug substances used for the manufacturing of said compounds are not only of material but also of financial value. In order to make research and development affordable, labs and clinical trials usually use miniscule volumes, for instance when working on highly complex individual therapies such as the CAR-T cell therapy.
This type of therapy has been successfully tested in the treatment of leukemia and researchers are confident to find further oncological applications in the near future. The CAR-T therapy requires the extraction of cells from the patient’s blood.
These will then be genetically modified in the lab before being re-injected. What sounds like a simple plan is in reality a tedious process that requires the repeated reliable and protected handling of small volumes of valuable substances.
So far, all established platforms have been geared towards the filtration and filling of large volumes of medical solution. The same is true for the freeze-thaw process, however, the research industry with its utilization of minimal amounts has been neglected.
This has changed: The Austrian startup SUSupport with its headquarters in the picturesque town of Kufstein has developed a platform that is scalable and geared towards use in labs where the handled volumes are usually as little as 0.03 to 0.2 fl oz. The system neither requires complicated adaptations nor extensions that might prove difficult to implement in a sterile setting and when time is of the essence.
Quite on the contrary, the platform is easy to adjust and can be delivered with or without filters. Its compact size is another advantage of the RoSS.pFTU lab scale and makes it the perfect solution for a scalable and monitored process for clinical studies.
With RoSS.pFTU lab scale, manual filtration and filling are a thing of the past. This smaller version of the RoSS.FILL system facilitates a monitored freeze-thaw process during the entire process of development, not only for CAR-T therapies but also for other potentially life-sustaining compounds.
Another significant advantage apart from the compact size and scalability of the platform is its compatibility with single use bags of all established brands and various sizes. RoSS.pFTU lab scale allows for an efficient filtration-, filling- and freezing process for volumes as little as 0.03 fl oz.
A monitored freeze-thaw process assures an optimal product stability so that the high-quality liquids do not lose any of their efficacy when frozen. In order to also protect the valuable drug substances during shipping, they are sent on their way in the RoSS shell, a protective container:
The filled and frozen single use bags are embedded in 3D foam to absorb external impacts and shocks, while a tamper-proof sleeve made of stainless steel offers additional stability and protection.
This combination protects the sensitive single use bags from potential damages that can, in the worst case, cause the contamination of an entire batch and lead to dire consequences.
RoSS.pFTU lab scale models an established pharmaceutical manufacturing process and reproduces it in a smaller scale for research and lab situations thus offering another important step towards more reliability and patient safety in the biopharmaceutical industry.