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.
The future for global advanced therapy shipments requiring critical chain of custody, chain of condition and Chain of Compliance® near real-time reporting are facing a significant technology change.
In February 2022, 2G/3G networks are sunsetting in the United States and immediately transitioning to only leveraging 4G/LTE networks. Other countries and regions will continue to leverage 2G/3G networks and will decommission them at different rates.
Topics in this presentation include:
North America’s Global Cellular Network Background and Current Status
Current State of the Supply Chain for High Technology Components Globally
Government, Aircraft, and Country Changes to Meet Regulatory Requirements
Next Generation Solutions for Logistics and Monitoring to meet Cell and Gene Therapy Industry Needs
Biopharmaceutical companies typically focus on the next clinical end point and securing a supply of product to meet their commitments to patients and investors. However, when approaching the end of the process development journey a sharper focus on considerations for an expedient and robust process characterization study can de-risk PPQ and improve the likelihood of successful commercialisation. In this presentation we will consider some simple steps that can be taken prior to the commencement of process characterization studies that will help ensure success.