The reason for this collaboration is the rapid establishment of Legend Biotech’s production 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 the utmost importance for both quality and operational purposes. The facility will house the production of innovative CAR-T cell cancer therapies.
As a new biotech company, developing and training operators and building industry-leading capabilities is key to success. Furthermore, Legend Biotech currently has no facilities in Europe, as construction of the facilities in Ghent is still in full swing.
The solution to both challenges is provided by the GxP Academy, Normec Advipro’s unique high-tech training facility featuring a fully operational cleanroom built to international GMP standards. This is the ideal environment for Legend Biotech operators to be trained in their procedures. In collaboration with Legend Biotech’s production manager, training manager, QA, and SMEs, Advipro has developed the five-day training course,“Introduction to GMP for Legend Biotech (GMP for ATMP, Contamination Control and Environmental Monitoring, Gowning and Aseptic Procedures),” specifically tailored to Legend Biotech’s production processes.
"We are thrilled to be collaborating with Legend Biotech on this exciting journey. It was an intensive process to work with various stakeholders within Legend Biotech to determine and develop the diverse topics in the program. Production Lead Sarah laid the initial groundwork, and we worked closely with the training lead and process owners to develop both the theoretical and practical modules. This enables the trainees to gain as much knowledge as possible and then put it into practice in our operational cleanrooms.” Alain Deloof - Manager, GXP Academy"
— Alain Deloof, Manager GxP Academy
What’s on the agenda?
- GMP with a focus on the production of CAR-T cell therapy. In addition, a workshop on their production process in accordance with EudraLex Volume 4, Part IV (specific to ATMPs).
- Working in a cleanroom: contamination control, what is a cleanroom, different types of cleanrooms, what constitutes product contamination, environmental monitoring, cleaning and disinfection, etc.
- We’ll examine donning procedures and how operators can apply them in their own cleanrooms. The entire donning process will be covered: from Grade D to an aseptic production environment.
- Process-specific training: Critical steps in CAR-T cell therapy, filling and finishing, visual inspection, etc.
About 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 derived from an antibody; a transmembrane domain; and the signal transduction elements of the T-cell receptor complex. The CAR antigen-binding domain seeks out tumor cells that express the target cell surface antigen. Once the CAR has found its target, it sends molecular signals via its intracellular modules to activate CAR-T cells, resulting in the destruction of the target tumor cells.
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