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.

Why Should You Attend:

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.

Whether the aggregates found during in vitro testing truly reflects the quantity and type of aggregates in vivo is not clear and continues to be debated. Nevertheless this debate has increased the scrutiny of reviewers on the testing and reporting of particulates in Protein Therapeutics.

This updated webinar addresses recent discussions in the industry related to testing sub-visible particulates in Biologics injectibles. Recent FDA expectations for reporting data will be discussed. Methods for characterization and routine testing of particulates, their advantages and limitations will be discussed. Case studies where the various methods have been used for characterization of the sub-visible particles will be discussed.

Areas Covered in the Seminar:

  • Why test for sub-visible particulates in protein therapeutics.
  • Current expectations for testing for particulates in protein therapeutics.
  • USP method for particulate testing in injectibles.
  • Commonly used 'work-horse' methods for particulates.
  • Characterization methods for particulates.
  • Newly emerging methods for subvisible particulates.