SUBVISIBLE PARTICLES MATTER, DEVELOPMENTS IN REGULATIONS AND LOW VOLUME METHODS

Presented By Dr Satish K Singh, Lonza

The need to measure and characterize proteinaceous particles in therapeutic protein products has been emphasized by regulators. USP 787 is a new chapter that addresses the limitations of USP 788 for therapeutic proteins in the measurement of subvisible particles. USP 1787 is a guidance chapter addressing the task of characterization of particles with an emphasis on proteinaceous particles. Furthermore, regulatory authorities require that sponsors understand the submicron particle size range of the products also. This article will look at the latest regulatory developments, key aspects of the measurement of subvisible and submicron particles in biotherapeutics, as well as the utility of low volume methods.