DEEPAK K. SHARMA,1 PETER OMA,1 SAMPATH KRISHNAN2
1ProteinSimple Technologies, Inc., 115 Terence Matthews Crescent, Ottawa, Ontario, Canada K2M 2B2
2Amgen, One Amgen Center Drive, Thousand Oaks CA, USA, 91320
PUBLICATION: Pharmaceutical Technology, 33(4): 74-79. (2009)
EXCERPTS:
Differentiating silicone oil and protein particles. The mixed silicone-oil droplet and aggregated protein sample was measured using MFI. Visual analysis of the captured images showed that the two particle types could easily be resolved for particles ≥5 µm ECD. Because silicone-oil droplets have a consistently higher aspect ratio compared with aggregated protein particles of the same size (see Figure 5), a simple software filter with an aspect ratio ≥0.85 and ECD ≥5 µm cutoff was applied to the mixed population. The images obtained in the two individual populations prior to mixing were visually examined to assess the accuracy of this filter. This comparison showed an accuracy of 96% for pure samples (i.e., 4% of the particles were incorrectly labeled as either silicone oil or protein aggregates).
Conclusions: MFI with automated particle classification is an emerging technology that can play a useful role in understanding and controlling silicone-oil-droplet-induced aggregation of proteins in parenteral pharmaceuticals. More generally, the ability of the technology to resolve and independently characterize mixed particle populations, including a wide range of subvisible and visible particle types, offers a rapid and powerful means of evaluating subvisible and visible particle populations in parenteral products.
LINK TO ARTICLE: http://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id=591864
