Analysis of subvisible particles
Particles below the size of around 100 µm are usually designated as subvisible particles. They can be further divided into micron (1-100 µm), submicron (0.1-1 µm), and nanometer particles or aggregates.1
Both proteinaceous and non-proteinaceous particles raise concerns because of their potential immunogenicity. The pharmacopeias (USP and Ph.Eur.) currently require quantification of subvisible particles in biopharmaceutical products above 10 µm and 25 µm. However, regulatory authorities show increasing interest in quantitative and qualitative particle data in the size range for 1 to 10 µm and qualitative data in the size range from 0.1 to 1 µm.
Furthermore, the combination of orthogonal techniques is clearly recommended and expected.
At Coriolis Pharma, we offer an extensive portfolio of techniques for subvisible particle analysis which were evaluated in several studies (see our list of PUBLICATIONS) and it is recommended to apply multiple techniques in parallel to obtain more reliable data by orthogonal techniques.
Some of these methods (Micro-Flow Imaging, light obscuration, AF4, HF5, SEC-MALLS) are provided to GMP level at Coriolis.
1. Narhi LO, Schmit J, Bechtold-Peters K, Sharma D 2012. Classification of protein aggregates. J Pharm Sci 101:493-498.