Development of a Manufacturing Platform Process for Multiple AAV Gene Therapy Vectors

Thursday, October 21, 2021 15:00 - 16:00 PM BST

Cell and Gene Therapies continue to offer exciting avenues as curative therapies for unmet patient needs in the ultra-rare, rare, and beyond rare clinical indications. To serve these unmet needs, cell and gene therapy companies are developing multiple products that are expected to rapidly advance from pre-clinical stages to clinical trials. 
Although development of every product may present a unique set of challenges, leveraging a manufacturing platform can help overcome specific barriers to the clinic. FUJIFILM Diosynth Biotechnologies’ (FDB) AAV manufacturing platform offers clients access to an end-to-end service, including a fully characterized, suspension adapted, clonal HEK293 cGMP cell line, research and cGMP-grade Rep/Cap, Helper, and GOI (backbone) plasmids, accelerating process development, in addition to a comprehensive array of analytical methods to support phase-appropriate product characterization and batch release testing. FDB’s AAV platform and process development & manufacturing approaches to other viral vectors will be discussed in this presentation.

Nigel Shipston,  Ph.D, ARCS, Director, Technical Marketing, Fujifim Disosynth Biotechnologies 

Ian Goodwin, Associate Director, Global Program Design Team,F ujifim Disosynth Biotechnologies 

Nigel Shipston

Ph.D, ARCS, Director, Technical Marketing, Fujifim Disosynth Biotechnologies


Ian Goodwin

Associate Director, Global Program Design team, Fujifim Disosynth Biotechnologies