Innovative approaches that address current challenges in gene therapy viral vector manufacturing
Scaling up the production of viral vectors, particularly adeno-associated virus (AAV), remains wrought with challenges. The issues of low titer and yield, and vector degradation such as unfolding, aggregation and oxidation, need to be better understood and managed by carefully optimizing buffer, pH and excipients. This article addresses key advancements at each step in the workflow — from maximizing titer output at scale upstream to optimized formulation compositions at fill/finish — to support commercial scale.
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.
