Subvisible particle analysis

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.