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Abstracts
Gene therapy is an emerging field that can provide cures for life-threatening diseases that do not respond well to other therapies and for acute conditions that currently rely on complex and expensive life-long medications.
This presents a significant opportunity for companies to help people with unmet medical needs live better lives. The need for speed is apparent in this “gold” rush as many companies are competing for the same indication.
This talk will provide an overview of the industry, process development bottlenecks, and viral vector production’s general aspects.
Lentivirus and AAV are the vectors of choice for gene-modified cell therapies and gene therapies. However, their production can be expensive due to adherent cell culture processes, inconsistent productivity, and open, manual handling.
For upstream process intensification, suspension-adapted cells, bioreactors, and templated processes are the methods of choice to improve safety and performance.
In this presentation, you will learn about the solutions offered through such production platforms, whether you are using HEK or insect-based processes.
Dr. Danielle DiTirro, Technical Specialist, BioReliance® Services
Various international regulatory documents define the requirements for the quality control of biotherapeutics. Although these guidelines are revised periodically, they lag behind dramatic scientific advancements in gene therapy products. Consequently, testing challenges for gene therapies exist compared to traditional therapies.
This presentation outlines current regulatory expectations for testing strategies. Methods for establishing safety from biological contaminants and product characterization will be reviewed, and state-of-the-art techniques to improve testing methods for gene therapies will be discussed.
Click HERE to watch the On Demand Event
