Improving Stability for Gene Therapy Products

“We’ve had decades to work out conditions for storing of biologics and small molecules,” says Brian Tomkowicz, PhD, senior director, vector engineering & manufacturability at the Center for Breakthrough Medicines in King of Prussia, PA.

“However, as we move into cell and gene therapies, significant challenges remain. For cell therapies, storage and handling of both cells and viral vectors are quite diverse and present numerous issues for long-term cryopreservation, and to maintain viability and activity post-thaw. While we may approach a virus like AAV as nothing more than a complex protein biologic, we need to understand the impact of these factors on the virus.

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