- The talk will give an overview on commercially available counting methodologies for detection of sub visible particles (SbVP). This species, ubiquitously present in protein formulations, had been in focus due to immunogenicity and quality attributes of Biotechnological products. Thus, the analytical toolbox to characterize them undergoes constant renewals and innovations. Their applicability towards the assessment of a meaningful array for particle counting characterization will be discussed including examples of their use in the frame of immunogenicity studies.
Anacelia Ríos Quiroz, Scientist - Group Leader Particle Lab Biologics, Roche