Gene Therapy upstream processing: adherent vs suspension cost modelling and perspectives

 

There is huge pressure on biomanufacturing facilities due to high demand for gene therapy products such as recombinant adeno-associated viral (AAV) vectors made under current good manufacturing practice (GMP) conditions. The constraints of the scale-up process are rarely taken into consideration during clinical process development, with many facilities simply scaling-out adherent cell stack protocols, procedures, and test methods. In order to demonstrate the importance of cost economics linked to the choice of scale-up processes, this study provides a detailed cost modeling analysis comparing viral vector production in adherent cells in cell stacks to viral vectors produced in bioreactors, either in suspension using a stirred bioreactor or adherently in iCELLis® fixed-bed bioreactor.

Speaker

Meriem Bendouma

Business Development Manager

Pall


Graduated from École Nationale d’Agronomie et des Industries Alimentaires in France, with a specialty in Bioprocessing. She first worked in mAbs development for diagnostic applications. She held different positions within PALL, including project manager for automated purification systems, bioprocess specialist, and now business development manager.

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