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.
Business Development Manager
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 Biotech, including project manager for automated purification systems, bioprocess specialist, and now business development manager.
Integrity Assurance for Single-Use Systems An End-User’s Perspective
What should you consider when building an integrity control strategy for your single-use systems (SUS)? How do you overcome application challenges?
Join leading industry experts Charlotte Masy of GSK and Patrick Evrard from Pall Corporation to gain insights and answers in this webinar from BioPharma Asia on integrity Assurance for Single-Use Systems, an End-User’s Perspective. They will present several case studies to show how integrity concerns can be practically addressed for cGMP manufacturing applications and the results observed a few years on.
Attendees will learn about:
- The latest regulatory requirements for integrity assurance of SUS
- The different technologies available to control integrity of SUS
- Key parameters that affect integrity measurements
Register now for this webinar from industry experts on October 6.