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Particulates in Biological Products - Evolving Regulations for Testing in Clinical and Commercial Stages

Instructor: Nanda Subbarao
Product ID: 701600
Training Level: Intermediate to Advanced
  • Duration: 90 Min
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This webinar will discuss the evolving regulatory requirments for testing Biologics injectibles for sub-visible Particulates.

Why Should You Attend:

There is an increased scrutiny on the testing and reporting of particulates in Protein Therapeutics.

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 may 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.

This 90-minute 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 Webinar:

  • 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

Who Will Benefit:

  • R&D Laboratory personnel
  • R&D Laboratory Supervisors and Management
  • QC Laboratory personnel and management
  • Protein Formulation Group personnel and Management
  • Regulatory Affairs personnel
  • Regulatory Affairs Management
  • QC Laboratory personnel and management
Instructor Profile:
Nanda Subbarao

Nanda Subbarao
Senior Consultant, Biologics Consulting Group

Dr. Subbarao, holds a Ph.D. in Bio-organic Chemistry. She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. As a consultant she has assisted pharma and biotech organizations in evaluation of analytical methods and method validation for a wide range of products ranging from conventional drugs to well characterized proteins and vaccines, from pre-clinical phase to commercial phases. She has been involved several times over her career in projects to setup or upgrade cGMP/GLP complaint Quality Systems for laboratory and stability programs for products during development and in commercial phase. She serves on the AAPS Stability Focus Group Steering Committee.

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