As potential components of all biopharmaceutical samples, particles can originate from various sources, including active pharmaceutical ingredients (APIs), formulation excipients, and manufacturing processes. The presence of these particles holds the potential to impact therapeutic safety and efficacy profoundly. Two primary reasons industries incorporate particle characterization into the drug development process: enhanced product quality control and gain a comprehensive understanding of products, ingredients, and processes.

By measuring essential particle properties like size, shape, surface attributes, mechanical traits, charge properties, and microstructure, industries gain invaluable insights into material behavior and for reliable and accurate analysis of aggregation problems. The analysis should reveal whether the particles are intrinsic, extrinsic, or inherent, what size they are, and what material they are made of. This helps to identify the source of the problem in order to find an appropriate solution, whether your drug substance is in preclinical development or already in the commercial phase. Discover how Leukocare’s advanced analytical techniques support the identification and characterization of particles — ranging from the sub-nanometer to the millimeter scale — contributing to improved patient safety and excellence in product development.