Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy

Importancia y uso:

4.1 This guide will encompass considerations for manufacturers regarding sources and potential causes of subvisible particles in biomanufacturing operations and the use of dynamic imaging particle analyzers as a suggested common method to monitor them. The guide will address the following components of particle analysis using dynamic imaging microscopy: fundamental principles, operation, image analysis methods, sample handling, instrument calibration, and data reporting.

Subcomité:

E55.14

Referida por:

E3230-20

Volúmen:

14.01

Número ICS:

11.100.20 (Biological evaluation of medical devices)

Palabras clave:

biologics; biopharmaceutical; diameter; direct imaging; droplet; dynamic imaging; flow imaging; flow microscopy; parenteral; particle; particle size distribution; protein; protein aggregates; subvisible particle;