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). [1]

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 [2].

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.

sFIDA – The Only Method Spanning the Full Critical Range



[1] Immunogenicity of Therapeutic Protein Aggregates, Moussa, Ehab M. et al., Journal of Pharmaceutical Sciences, Volume 105, Issue 2, 417 – 430

[2] Guidance for the industry, Immunogenicity Assessment for Therapeutic Protein Products, FDA, 2014