Steps To Overcome Challenges Associated With Biologic Formulation Development

Six years ago, two-thirds of all drugs in the development pipeline were small molecules. Today, while still leading the market, that number is just under 50% this year, according to an industry report conducted by PharmaCircle LLC in conjunction with Drug Development & Delivery. One technology that is growing, particularly in Phase I development, is biologics. In fact, nearly 45% of the 20,000+ drugs in the development pipeline are biologics.¹

The rest of the decade is going to continue this trend. Biologics are projected to have 10.7% annual growth rate to 2025 and just under 10% for the five years after that.² A more geriatric population, rising need for immunology, and government initiatives are three of the main reasons attributing to this growth.

This article explores guidance on the challenges posed by biologics, including overcoming degradation, establishing a stress test process, and the value of lipid nanoparticles (LNPs) and polymeric nanoparticles (NPs).