Placing filtration into gene therapy platforms – potential and remaining challenges

Early gene therapy manufacturing has largely borrowed technologies developed for recombinant protein processing. This has generally translated well, but there is still significant work to be done to improve process outputs (e.g. yield, cost, product quality) and assess their platform potential.

In this work we will focus on filtration technologies and assess which have translated well, and how process development has changed for these new modalities. We will also highlight where new technologies need to be developed specifically for gene therapy processing. This talk will put particular focus on adventitious agent clearance (virus, bioburden) with an eye towards converging on platforms for some of the major viral vector classes. Data is available from adeno-associated virus (AAV) and lentivirus processes.