Turning obstacles into opportunities: overcoming efficiency and quality challenges in gene therapy development
As the FDA signals stronger support for advancing gene therapy approvals, manufacturers face increasing pressure to get to market quickly while maintaining viral vector quality. This article tackles emerging scale-up challenges to efficiency and safety, with an in-depth look at strategies to optimize viral vector production, manage costs, and collaborate on industry standardization and automation.
New Strategies for a Better Glycosylation Profile
January 22nd 2025Glycan analysis provides key information on critical quality attributes that could affect stability, safety and efficacy of a protein therapeutic. Specific needs for understanding the glycosylation profiles change throughout the drug development process, but the requirement for high-resolution glycan information remains the same and is essential to help ensure product quality.
