On June 14th flanders.bio and Roche Diagnostics are organizing their 3rd Joint Partner Day : ‘’Towards high-quality Cell Therapy’ .
This meeting will introduce the Belgian ecosystem on cell therapy and take you through the different aspects and critical steps within the development and manufacturing of cell therapy.
At this meeting our colleague Jessika Wynendaele gave a lecture on how your analytical tests can be translated to the GMP level.
TRANSLATING YOUR ANALYTICAL TEST TO THE GMP LEVEL
Development of cell based products in clinical stage is an adventure, however bringing the product to the market is like a trip to the moon. In order to achieve a perfect moon landing, risk management, quality control and a cost effective traject are necessary. anacura Life Sciences provides guidance to achieve your final destination.
At anacura Life Sciences we established a series of analytical tools to accelerate our clients’ product development cycle. The success rate can be increased by developing the right assay in early development up to quality control. For instance, identification of suitable potency assay as an early milestone reduces risk of failure or manufacturing limitations later on. Together with our clients and suppliers we design the most suitable validation approach.
In a nutshell, we will highlight our tailor–made validation strategy, our flight plan to the moon.
In case of emergency, please contact Jessika Wynendaele: firstname.lastname@example.org