🧬 Viralgen is a Contract Development and Manufacturing Organization specializing in Adeno-Associated Virus (AAV) gene therapy products.
🧪 The gene therapy industry faces challenges related to the evolving regulatory landscape and limited available data for setting acceptance criteria.
🔬 Viralgen leverages historical data and innovative approaches to navigate these challenges.
💼 Gain valuable insights from the Chemistry, Manufacturing, and Controls (CMC) perspective and learn how regulatory agencies support sponsors.
Introduction:
In this article, we explore the challenges and barriers in gene therapy from a regulatory perspective. María Orío, the head of regulatory affairs at Viralgen, discusses how the gene therapy industry is navigating the evolving regulatory landscape and setting acceptance criteria with limited available data. She also highlights the mission of Viralgen as a Contract Development and Manufacturing Organization specializing in Adeno-Associated Virus (AAV) gene therapy products and how they address these challenges using historical data and innovative approaches.
- Gene therapy industry faces unique challenges in regulatory compliance.
- Evolving regulatory landscape requires continuous adaptation in gene therapy.
- Setting acceptance criteria with limited data poses challenges in gene therapy.
- Viralgen leverages historical data and innovative approaches to address regulatory challenges.
- Regulatory agencies actively support sponsors in the development of life-changing gene therapies.
Conclusion:
Gene therapy is a promising field of research, but it faces significant regulatory challenges. The evolving regulatory landscape and the limited availability of data for setting acceptance criteria add complexity to the development and manufacturing of gene therapy products. However, companies like Viralgen are addressing these challenges by leveraging historical data and adopting innovative approaches. Regulatory agencies are also actively supporting sponsors in their quest to bring life-changing treatments to patients. With continued collaboration between industry and regulators, these barriers can be overcome, enabling the advancement of gene therapy and its potential to revolutionize medical treatments.
