What Modern High-Concentration Monoclonal Antibodies Taught Us – And How Lipid Nanoparticle Therapeutics Must Adapt

Drug Discovery and Development

Author: Dr. Soumen Saha

Lipid nanoparticle (LNP) therapeutics have revolutionised nucleic acid medicine, yet currently approved products remain relatively low in active nucleic acid payload concentration compared with modern high-concentration monoclonal antibody (mAb) therapies.
The evolution of high-concentration mAbs demonstrates how clinical demands for subcutaneous delivery, reduced injection volumes, and self-administration drove advances in formulation design, manufacturing and analytical characterisation, while also introducing challenges related to viscosity, aggregation and particulate matter.
As LNP therapeutics expand toward protein replacement, gene editing and chronic dosing, analogous formulation, manufacturability and characterisation challenges may emerge. This perspective discusses how lessons from three decades of mAb development can help proactively guide the formulation and characterisation of next-generation LNP therapeutics

Read the full publication (page 82-87):  https://pharmapress.co.uk/editions/5634/