4 hacks that allow you to push patient safety during cell and gene therapies to the next level

cgt-stream-car-t-zelltherapie-patientensicherheit-maximieren

Car-T: A medical dream becomes reality

Scientists have been researching CAR-T cells ever since the late 1980s with the aim to manipulate the T- cells in such a way that they recognize and fight cancer cells. The breakthrough finally came in 2010 when two patients suffering from chronic lymphocytic leukemia were treated successfully with T cell therapies.

Both patients were regarded as beyond treatment as the cancer progressed no matter what therapy they received; the CAR-T cell therapy was the last resort for these patients. The next success came in 2012, when a kid suffering from CLL could be treated successfully for the first time – it has since been cancer-free.

CAR-T cell therapy problems and risks

It truly does sound like a medical dream come true: A cancer immunotherapy which basically allows the body to heal itself with the help of manipulated T cells. Unfortunately it sounds easier than it is, and like any other medical therapy the CAR-T cell therapy poses certain challenges and risks.

At Single Use Support we are certain that one of the main issues of CAR-T therapies – the logistical challenges – can be solved with our single use technologies. We have found a way to bring the therapy to the patient in a safe and protected manner.

 

Our CAR-T logistics process

 

Currently, around 1-3% of therapies are rendered useless by the time they reach the patient, either due to uncontrolled interruptions in the cold chain or single use bags with material deficiencies, which in turn will lead to (bio) contamination during the filling process.

These things happen because so far the biopharmaceutical industry has been catering for the shipping of large volumes of liquid; so far, solutions for the global shipment of small batches have been missing. And CAR-T therapies require approx. 50 ml to 0.5 l.

At Single Use Support we have been tackling this issue and have developed technologies to minimize the risk of bio contamination, manipulation and product loss towards 0%. Absolute patient safety is our top priority – after all, each lost therapy can cost a life.

CGT.STREAM – our logistical solution for a successful CAR-T cell therapy

The CGT.STREAM is a logistical process we developed. It is based on industry standards like single use bags of all sizes and from any manufacturer. With our technologies, we build a framework of preventive and protective measures around this standard that offer a new level of quality.

Our development promotes the strengths of single use bags while at the same time compensating potential weaknesses and risks like material deficiencies or the outer skin’s sensitivity. Our products and tried-and-tested processes can eliminate flaws by 100%.

We have built this logistic process for small and very small quantities upon four pillars:

  1. Test
  2. Protect
  3. Freeze & Thaw
  4. Store, Ship, Track & Trace

1. The integrity of single use bags is tested with MITS.2D

MITS.2D is our fully automated integrity test for single use bags. It tests single use bags of any manufacturer and with a volume of up to 20 L in less than 60 seconds. MITS.2D not only guarantees full integrity but also minimizes the risk of bio contamination with bioburden and endotoxins.

2. RoSS.KSET protects single use bags throughout the entire logistics process

Throughout the entire logistics process, RoSS.KSET (the small sister of RoSS®) offers an absolutely protective and compact tray for the tested single use bag. A hard shell made of stainless steel offers both ideal protection against external impact and ideal temperature distribution during the freeze & thaw process. The soft core made of 3D foam adapts to the shape of the single use bag and can expand during the freezing process. An innovative and intuitive locking mechanism simplifies handling and protects against manipulation.

3. Reliable freezing and thawing with our freeze-thaw platforms

Especially in times of CAR-T and CGT, reliable freezing and thawing is more important than ever. Our RoSS.pFTU small scale plate freezer has been specifically developed for the freezing and thawing of small quantities of liquid in single use bags of any manufacturer. The technology, which is based on the use of plates, allows for fast and constant freezing, which increases reliability. For lab studies, we have developed RoSS.pFTU “lab scale” – ideal for the implementation of a controllable and optimally scalable freezing process. Our smallest freezing unit is available for rent. You can rent and test it for three months. Should you decide to purchase, the rent will be deducted from the purchasing price.

4. Reliable storing and shipping of single use bags with RoSS.KSETs

CGT.RACK is a container made from highly robust stainless steel that is compact, temperature-resistant up to -200 °C/-328 °F, lockable and tamper-proof. The system offers space for several RoSS.KSET units and is suitable for the fixed placing in shippers of all established manufacturers (Cryoport, Savsu, Deware, …).