|
|
|
|
Explore challenges and solutions in developing novel AAV capsids, focusing on manufacturing complexity, analytical testing, and regulatory considerations for advancing gene therapy effectiveness.
|
|
|
|
|
Modern AAV manufacturing demands precise capsid characterization to distinguish empty, partial, and full particles, as regulators now require rigorous purity and potency control for clinical safety.
|
|
|
|
|
Fragmented, manual data practices slow tech transfer and increase risk; centralized digital CMC systems standardize workflows, improve transparency, and accelerate onboarding while maintaining compliance.
|
|
|
|
|
Viralgen’s Andy Holt at Meeting on the Mesa 2025 highlighted in-house plasmid manufacturing, expanded commercialization development, and cost reduction in gene therapy manufacturing.
|
|
|
