Watch Now: Cell & Gene Therapy On-Demand Event

by Jessica Hogan | April 12, 2023

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Click HERE to watch the On Demand Event


Riding the Gene Therapy Roller Coaster
Ratish Krishnan, Senior Strategy Consultant, Novel Modalities BioProcessing

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.

Upstream Platform Solutions for your Gene Therapy Needs
Kate Achtien, Program Manager, BeyondCHO Products and Innovations
Katie Schewe, Product Manager, Upstream Bioprocessing

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.

Zoom in on cell therapy manufacturing, emerging trends, and advanced processes
Dr. Antoine Heron, Principal Consultant, Cell Therapy & Novel Modalities
Cell therapy manufacturing is complex, labor-intensive, and expensive. But start-up companies generally focus on “speed to clinic” and “first to human” as the primary drivers, superseding efforts to develop a robust manufacturing strategy or effective transitions from lab-scale to commercial readiness.
This presentation will discuss these complex drivers, how to prevent complexity, and process design during early clinical development.
Additionally, we will outline how to leverage automated manufacturing and real-time analytical solutions to support quality by design approach.
Navigating the Landscape of QC Testing for Gene Therapy 

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

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