Ensuring quality and compliance in a rapidly evolving industry.

Challenges of navigating a complex and evolving regulatory environment can present a significant barrier to bringing viral gene therapies to market.

Regulatory bodies, including the US Federal Drug Administration (FDA) and European Medicines Agency (EMA), have introduced various accelerated pathways to facilitate the development of therapies for unmet medical needs, while simultaneously the industry has increased its focus on Chemistry, Manufacturing, and Controls (CMC) to ensure product quality.

This whitepaper discusses:

• Regulatory pathways for therapy development
• Regulatory perspectives on plasmid DNA
• The importance of quality assurance and process optimization
• Critical attributes in selecting a Contract Development and Manufacturing Organization (CDMO) partner

Learn how to overcome regulatory barriers in your gene therapy development.