Navigate The Complexities Of Cell And Gene Therapies With Regulatory And CMC Expertise

A biopharmaceutical company focused on developing novel autologous T cell therapies had promising findings targeting a rare-disease tumor type. The Cardinal Health Regulatory Sciences team provided strategic regulatory and CMC expertise to help guide the regulatory and development strategy.

The team helped assemble their Investigational New Drug (IND) application by providing necessary data within a short timeframe. Specific product quality information was needed on ancillary material, so the team formulated a strategy and assembled all outstanding information. The team also assisted with incidents and amendments during the clinical trial, ensuring the therapy's continuous improvement and maintenance of product quality.

Access the full case study to discover how the orphan drug moved forward to be in phase 1 clinical trials with multiple lots successfully administered.