Abstract

Scale-up Development and Manufacturing of Nanomedicines: From Tech Transfer to Clinical Batch

Chiara Pretto, Senior Scientist, Process Development, Ardena

Nanomedicines represent the cutting-edge frontier in the pharmacological field, providing unique solutions for the treatment of various diseases as well as for imaging purposes. The rapid advancement in this field poses significant challenges to clinical development and requires a carefully planned development scheme executed by scientists experienced in nanoparticle synthesis and characterization. As a contract development and manufacturing organization at the forefront of the nanomedicine landscape, Ardena embraces these challenges and can provide fine-tuning of manufacturing techniques, development of tailor-made reproducible, scalable, and GMP-amenable processes as well as full characterization of products. We will present how we navigate our customer’s lead nanomedicines through drug development, and we will highlight some of the challenges in bringing nanoparticles-based therapeutics from discovery to the clinic.