Late-Stage Development And Manufacturing Of Novel Excipients For Precision Nanomedicines And Targeted Therapies

By Dirk-Jan van Zoelen, Ph.D., Drug Substance Business Unit Director, Ardena Oss, Netherlands

Nanoparticle drug delivery is raising expectations for excipients, which are now expected to do far more than maintain formulation stability. Advanced lipids and related materials increasingly influence biodistribution, release characteristics, and clinical outcomes, placing them under regulatory scrutiny comparable to active ingredients. Follow how novel excipients move from early synthesis into late‑stage development and GMP manufacturing, using real‑world examples from lipid‑based nanomedicines and oncology programs.

Read its challenges, such as designing routes that will scale, replacing laboratory techniques that break down at manufacturing volumes, controlling impurities through careful starting material selection, and defining the material attributes and process parameters that truly matter. Analytical hurdles specific to lipid systems are also examined, including situations where conventional methods fall short and how teams balance yield, purity, and compliance. Together, these insights show how robust control strategies can satisfy regulators while still enabling efficient scale‑up, supporting the reliable transition of complex nanomedicine formulations into clinical manufacturing.