When developing a therapeutic for clinical use, technology transfer is a crucial step. This path is often made more challenging when the therapeutic is based on a relatively new technology whose regulation is still being defined, such as nanoparticles.
Seeking necessary input from experienced regulatory, quality, and CMC personnel, as well as partnering with an experienced CDMO, can help streamline this complex aspect of clinical development.
Designed for the biopharma community, this playbook addresses: