At the forefront of gene therapy innovation, Viralgen is redefining how advanced therapy medicinal products (ATMPs) are manufactured. “Streamlining Advanced Therapy Medicinal Product Manufacturing: A Platform Approach for Accelerating Gene Therapy Commercialization” highlights how Viralgen's platform-based strategy enables faster, more efficient, and scalable gene therapy production.
Key Takeaways from the Platform Approach:
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Suspension-based manufacturing using HEK293 cells in Pro10™ medium allows for high-yield production of AAV vectors while maintaining consistent product quality.
- Scalability from clinical to commercial scale is built into the process, with proven success across multiple serotypes and therapeutic areas.
- Quality by Design (QbD) principles guide every step—from plasmid production to final product release—resulting in more predictable, reproducible, and regulatory-compliant outcomes.
