How CDMOs Can Support Nanoparticles For Gene Therapy, Immuno-Oncology & Vaccines

By Jee Look, Senior Director of Drug Product Development, Emergent

The technologies and knowledge required to develop and produce commercial scale nanoparticles are so comparatively new that finding a CDMO with the right equipment and process development expertise to scale-up and manufacture these materials can represent a complex ask. Companies may engage a CDMO for early-phase material only to find it necessary to look elsewhere when it comes time to transition to GMP-scale production. Even partners with nanoparticle experience in other sectors are likely to encounter challenges when it comes to transitioning to nanoparticle production in the biopharmaceutical industry, thanks to the highly bespoke equipment and protocols that attend their production for use in therapeutics.

Ideally, a biopharmaceutical company pursuing a project requiring nanoparticle production will identify a CDMO partner that can support early-phase formulation, drug product studies, clinical trial activities, and ultimately, commercial manufacturing. This can be a difficult proposition, as finding a partner capable of producing even early-phase materials can be challenging in the current landscape, where longstanding, in-depth expertise is few and far between. Various nanoparticle vehicles require distinct technology solutions for their production, therefore engaging in tech transfer during scale-up has the potential to create added complexity, forcing developers to pursue new facility builds or revisit key development milestones to facilitate GMP production.