Advipro and Legend Biotech work together on training CAR-T technicians and experts
We are proud to announce that Legend Biotech and Advipro are working together for the development and organization of a process specific five-day training course at the GxP Academy.
The reason for this collaboration is the fast track establishment of the Legend Biotech manufacturing organization in Belgium. Training large numbers of technicians and experts to prepare them for the state-of-the-art production facility in Zwijnaarde, Belgium, is of utmost importance for both quality and operational purposes. The facility, which will host the innovative CAR-T cell cancer therapy production.
As a new biotech company, developing and training operators, and building industry leading capability is key to succes. In addition, Legend Biotech does not have any facilities to this day in Europe, as the construction of the facilities in Ghent is still in progress.
The solution for both problems is provided by the GxP Academy, Advipro's unique high tech training facility with a fully operational cleanroom built according to international GMP standards, is the ideal environment for Legend Biotech operators to be trained in their procedures. In collaboration with Legend Biotech's production lead, training lead, QA and SMEs, Advipro has developed the five-day training course, “Introduction into GMP FOR Legend Biotech (GMP for ATMP, Contamination Control and Environmental Monitoring, Gowning and Aseptic Procedures)”, specific for Legend Biotech's production processes.
“We are ecstatic to collaborate with Legend Biotech for this interesting journey. It has been a very intense process to work together with different parties within Legend Biotech to determine and develop the different topics present in the program. Production lead Sarah laid the first foundation and we also worked intensively with the training lead and process SME’s to develop both the theoretical and practical modules in order to give the trainee as much knowledge as possible and to allow them to put that knowledge to practice in our operational cleanrooms.”
What's on the agenda?
- GMP with the focus on the production of CAR-T cell therapy. In addition, a workshop on their production process taking EudraLex volume 4 part IV (specific for ATMP) into account.
- Working in a cleanroom: contamination control, what is a cleanroom, different types of cleanrooms, what is contamination of a product, environmental monitoring, cleaning and disinfection,… .
- We look at gowning procedures and how the operators can apply this in their own cleanroom. The entire gowning process is addressed: from Grade D up to an aseptic production environment.
- Process specific training: Critical steps in CAR-T cell therapy, fill and finishing, visual inspection, … .
About the CAR-T Cell Therapy
CAR-T cells are genetically modified T cells that express a chimeric antigen receptor (CAR), a three-part hybrid protein: a tandem antigen-binding domain of an antibody; a transmembrane domain; and the signal transduction elements of the T cell receptor complex. The CAR antigen binding domain looks for tumor cells expressing the target cell surface antigen.
Once the CAR has found its target, it sends out molecular signals through its intracellular modules to activate CAR-T cells, resulting in destruction of the target tumor cells.