Microfluidic cIJM Technology for Robust, CMC‑Aligned Manufacturing of Therapeutic Nanoparticles

Silvia Alonso de Castro – R&D Team Leader, Curapath; Carla Colprim – R&D Technician, Curapath; Aroa Duro Castaño – R&D Director, Curapath; Elena Gallon – BD Associate, Curapath; Ines Garcia – R&D Technician, Curapath; Lidia Herrera – R&D Manager, Curapath; Paula Martínez Colomina – R&D Technician, Curapath; Javier Martínez-Faraez – R&D Technician, Curapath; Rafael Miravet-Martí – R&D Team Leader, Curapath; Vicent Nebot Carda – Chief Technical Officer, Curapath; Veronica Serrano – R&D Technician, Curapath

Introduction:

The development and commercialization of advanced drug delivery systems increasingly hinge on overcoming stringent CMC (Chemistry, Manufacturing, and Controls) requirements. Nanoparticle-based therapeutics, while highly promising, face persistent challenges related to batch-to-batch reproducibility, process scalability, product robustness, and regulatory expectations for well‑characterized, tightly controlled manufacturing workflows. As formulations evolve—from simple liposomes to lipid nanoparticles (LNPs)—the need for a manufacturing platform that ensures precise mixing, consistent physicochemical attributes, and seamless scale-up has become critical.