12.18.25 -- Exploring Outsourcing's Role In CGT Scalability And Affordability

Discover how automation and digitalization are transforming cell and gene therapy with scalable, decentralized manufacturing and smarter market navigation.

Since 2024, multiple cell and gene therapy programs faced regulatory delays due to manufacturing deficiencies, highlighting the critical need for robust CMC strategies and inspection-ready operations.

Uncover how scalable innovation is transforming viral vector production and driving broader, more equitable access to advanced gene therapies.

Addressing the complexities of viral vector manufacturing through strategic internalization, advanced technologies, and regulatory excellence is crucial for the future of gene therapies.

Explore how TARGATT™ gene editing and HLA-F technologies are revolutionizing hypoimmunogenic cell development for scalable allogeneic therapies.

Establishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.

Standardized methods, materials, and analytics are critical for overcoming hurdles in the gene therapy space. See how a platform approach to fast-track AAVs can enhance quality and efficiency.

Investigating the challenge of rcAAV testing for AAV serotypes beyond AAV2 is crucial for gene therapy safety. Serotype-specific factors impact infectivity, necessitating method refinement for reliable results.

Early, phase-appropriate CMC planning is critical for advanced therapy success. Proactively managing regulatory risks and applying Quality by Design principles secures a clear path to market.

Improved iPBMC manufacturing boosts TIL therapy reliability, safety, and affordability through donor screening, process refinements, and performance-based cell selection.

GMP-Source is a robust alternative to cGMP production that mirrors nearly all of the oversight and standards of full production while relaxing commercial standards, helping companies overcome the hurdles in development.

Ensuring the safety and efficacy of cell and gene therapy treatments necessitates rigorous quality control. Assimilate how an outsourcing partner can help you deliver safe, efficacious therapies to patients.