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.