04.13.26 -- Derisk Multimodal CGT Manufacturing With These Key CDMO Capabilities

Analytical technologies like Droplet Digital PCR (ddPCR) provide a more rapid and robust approach to nucleic acid quantification for better sensitivity, accuracy, and precision in therapeutic development.

Successful cell collection depends on accessing a large, diverse donor pool. Learning how robust donor screening and highly efficient collection practices are essential to ensuring product quality.

Reliable safety outcomes require phase-appropriate design and strong virus stocks. Ensure success by applying modality-specific risk assessments aligned with today’s evolving regulations.

Experts note CGT programs often struggle due to limited operational readiness; early standardization supports scalable, reproducible, regulatory‑ready development and helps prevent late‑stage bottlenecks.

Bridge the gap between in vitro research and human physiology by utilizing high-purity primary cells. Accessing diverse cell types and optimized media ensures research remains biologically relevant and reproducible.

Rapid cell therapy development demands early planning for scalability, standardized platforms, and inspection‑ready operations to meet rising regulatory expectations and avoid costly rework.

Early, phase-appropriate CMC planning is vital. Proactively manage regulatory risks and apply Quality by Design principles to secure a clear, predictable path to commercial market entry.

This panel session features a decade-long story of a partnership and how they brought two life-changing gene therapies to market successfully in 2022.

Cost-effective agarose gel electrophoresis offers reliable plasmid supercoil and host DNA/RNA quantification, providing a practical alternative to qPCR and HPLC for biomanufacturing quality control.

Uncover the benefits of this CGMP-ready, stable AAV packaging cell line with proven expertise to reduce costs, streamline manufacturing, and make life-changing gene therapies more accessible to patients in need.

Low AAV productivity and lack of platform processes continue to be key challenges driving AAV production cost up. Explore a robust and scalable suspension manufacturing platform for AAV production.