Vision Analytical Inc., a leader in particle size and shape analysis, today announced new insights into the evolving role of analytical techniques in subvisible particle characterization, particularly in the context of United States Pharmacopeia (USP) Chapter <1788>.
Subvisible particle analysis remains a critical component in the development and quality control of biologics, where particle size, morphology, and composition can significantly impact product stability, efficacy, and patient safety. While traditional methods such as light obscuration have long been used for compendial testing, emerging regulatory guidance and scientific understanding are driving increased interest in orthogonal techniques that provide additional particle characterization.
USP <1788>, which addresses methods for determining subvisible particle size distribution, emphasizes the importance of using complementary analytical approaches to better understand particle populations. This shift reflects broader industry recognition that particle characterization extends beyond simple size measurement.
“Subvisible particle analysis is no longer just about counting particles within a size range,” said Peter Bouza, President of Vision Analytical. “There is a growing need to understand particle morphology, differentiate between intrinsic and extrinsic particles, and identify potential sources of contamination. These are areas where advanced imaging techniques can provide significant value.”
Dynamic Image Analysis (DIA) is one such technique gaining attention for its ability to provide both size and shape information, along with visual confirmation through particle imaging. These capabilities can support more informed decision-making during formulation development, process optimization, and root cause investigations.
As the biopharmaceutical industry continues to evolve, the integration of complementary analytical methods is expected to play an increasingly important role in ensuring product quality and regulatory compliance.
Vision Analytical is actively engaged in supporting the industry’s transition toward more comprehensive particle characterization strategies through educational initiatives, application studies, and collaboration with regulatory and scientific communities.
For more information on subvisible particle analysis and emerging methodologies, visit www.ParticleShape.com.
About Vision Analytical Inc.
Vision Analytical Inc. specializes in advanced particle size and shape analysis solutions, leveraging Dynamic Image Analysis technology to provide detailed particle characterization across a range of industries, including pharmaceuticals, fuels, and materials science.