As ATMPs (Advanced Therapy Medicinal Products) are one of our focal points, we are obviously very happy with the news that the Belgian minister of Social Affairs and Health has approved the refundability of Car-T Therapy. From now on (as of June 1 to be precise), the following people can benefit from this refund:
- Children and adolescents with acute lymphoid leukaemia, for whom other treatments have proven to be insufficiently effective
- Adults suffering from aggressive lymphoid cancer
Open the door
This decision finally opens the door to a new treatment for dozens of Belgian patients, for whom the current treatments don’t work. Over the upcoming twelve months, this new therapy will help approximately fifty patients. In the year that follows, that number will rise to about ninety.
But how does CAR-T cell treatment work? In case of lymphoid cancer, some lymphocytes are extracted from the patient and a piece of his DNA is added. This enables the body to better recognize malignant cells and to aim its attack more precisely. These ‘armed’ cells are then administered to the patient via a drip.
Cloud-based software platform
QbD and Antleron have been dreaming of, and fighting for, more affordable personalised medicines for a while now. The results of these therapies are much more positive and sustainable than those of classic therapies.
That is why the companies joined forces and developed Cell by Design, a cloud-based software platform that facilitates scalable, cost-effective and sustainable ATMP process development.
The backbone of CbD is a quality-focused process development roadmap. Risk-based process assessments guide science and data-driven decisions in order to meet all pre-defined critical quality attributes of the ATMP.
In addition to quality, manufacturability and scalability of the developed product and process are also key in CbD. Therefore, this is taken into account right from the start of a development trajectory, to ensure a one hundred percent closed and automated process.
Finally, cost effectiveness is highly valued by CbD. E.g. Quality Control often makes up a significant part of the manufacturing costs. By using CbD, it is possible to build a design space of the process and product and to apply cheaper parametric releases.
If you would like more information about what Cell by Design could mean for you, don’t hesitate to contact us.