DEC 14, 2020 10:00 AM PST

Testing Vaccines final dose form to USP<787> Subvisible Particulate Matter

Speaker

Abstract

DATE:  December 14, 2020

TIME:  10:00am PST

 

USP chapter <787>, Subvisible Particulate Matter in Therapeutic Protein Injections, became official August 1, 2014 and provides specific guidance for testing the final dose form of protein-based formulations, such as vaccines. This regulation focuses specifically on protein formulations and, unlike USP<788>, allows the user to test a smaller number of finished product as well as take smaller test aliquots. This paper discusses the challenges that fully implementing USP<787> presents to liquid particle counters with inherently large tare volumes, poor sample-to-sample repeatability with such low sample volumes and inability to precisely deliver small volumes and how the HIAC 9703+ liquid particle counter from Beckman Coulter overcomes these challenges.

 

Learning Objectives:

  • Vaccine testing to USP<787>: learn the challenges when using USP<787> for testing vaccines

  • Learn the difference between USP<788> and USP<787>

  • Learn why Light Obscuration is the preferred technology for measuring and counting particle contamination in both USP<787> and USP <788>

  • Learn how the HIAC 9703+ Light Obscuration analyser from Beckman Coulter is designed specifically to help you successfully apply USP<787> to vaccine testing

 

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DEC 14, 2020 10:00 AM PST

Testing Vaccines final dose form to USP<787> Subvisible Particulate Matter



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