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


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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
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: N.S, Senior Consultant, Biologics Consulting Group

Speaker is currently the Group Leader for Analytics CMC Group and Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC, and GLP/GMP Quality Systems. She has assisted pharma and biotech organizations in the evaluation of analytical methods and method validation for a wide range of products from the pre-clinical phase to commercial phases. Some specific technical areas include small-molecule pharmaceuticals, well-characterized proteins including biosimilars and vaccines.  Her consulting areas include GMP systems design and implementation focusing on laboratory and stability systems, data integrity, and equipment.  She currently serves as an Editorial Advisor for Bioprocess International.  

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