Biotech 2012 - Particulates in Biological products. Why test them and what are the new reporting requirements

The FDA has requested BLA sponsors to submit sub-visible particulate data for Well Characterized Protein Products in the clinical and commercial phases. The evidence continues to accumulate that particulates increase immunogenicity of the protein product. The regulatory requirements for testing Biologics for Particulates continue to evolve.

Proteinaceous Particulates in Biologics injectibles can arise from the aggregation of the protein product and can be induced by silicone droplets, metal particles and glass particles. Aggregates in protein products present a safety concern because they increase the immunogenicity of the product. The FDA has therefore requested BLA sponsors to present sub-visible particulate data at the clinical and commercial stage. The initially identified method ?gap for suitable techniques for testing particles in the 0.2 - 10 micron range is being rapidly filled by new technologies.