Subvisible particle analysis
ultrasensitive quantitation and sizing of aggregates for development and QC of biologicals
Protein Aggregation – A Source of Multiple Risks in R&D of Biologicals
Aggregation is a common instability observed with biologicals or protein drugs that can occur throughout the life cycle, beginning from early upstream processes until clinical application. Aggregates have a negative impact on efficacy, biodistribution, and can cause adverse immune reactions in patients that can ultimately lead to the generation of anti-drug antibodies (ADA). 
According to the FDA, subvisible aggregates ranging from 0.1-1 µm are of special concern regarding immunogenicity. At the same time, the FDA deplores the lack of quantitative methods covering this critical size range .
sFIDA determines concentration and size of particles in the full critical size range and beyond. sFIDA is optimized for minimal sample usage (< 1 µl) and detects both soluble and insoluble aggregates also in complex matrices, such as cell culture media.
 Immunogenicity of Therapeutic Protein Aggregates, Moussa, Ehab M. et al., Journal of Pharmaceutical Sciences, Volume 105, Issue 2, 417 – 430
 Guidance for the industry, Immunogenicity Assessment for Therapeutic Protein Products, FDA, 2014