The promise of new gene therapies for patients with few or no treatments available is driving demand for rapid innovation, with hundreds of gene therapies now in development worldwide. But bringing a new gene therapy to life demands a high degree of expertise in viral vector manufacturing and testing. Yet there are many challenges to producing a gene therapy including accelerated time-to-patient, lack of an established process template, and evolving regulatory guidelines.
Gene therapy manufacturers must find their own path through complex obstacles in process development, scale-up, manufacturing, and regulatory compliance – all within compressed timelines of just 3-5 years, less than half the time for conventional drugs.
Successful manufacturers must also show agility in clearing regulatory, safety, and process development hurdles. Consequently, alliances with experienced global technology partners or contract development and manufacturing organizations (CDMOs) are often essential for bringing a gene therapy to life.
Article: Ensuring Viral Vector Supply For Gene Therapies
Article: The Roller Coaster of Gene Therapy Manufacturing
Article: Gene Therapies: Overcoming the Biggest Challenges in Gene Therapy Manufacturing
Article: Updated US FDA Guidance For The Gene Therapy Industry: Key Changes And Areas Of Increased Focus
Article: The Future of MilliporeSigma's Gene Therapy CDMO Through the Lens of History
Article: Anticipating the Next Decade of Gene Therapy
Article: Beyond 2020: Looking into the Crystal Ball for Gene Therapy
Infographic: Making Rare Disease Therapies Less Rare (Labiotech)
Article: Regionalizing and Democratizing Cell and Gene Therapy
Article: Perspectives of Value-driven, Integrated Solutions in Gene Therapy
Poster: AAV Process Development Guidance Based on Cost Modeling