Evolving Regulatory expectation for Particulates in Biologics

This webinar addresses evolving regulatory requirements for particulates and the techniques suitable for testing and characterizing sub-visible particulates in therapeutic formulations.

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Why Should You Attend:
Particulate analysis in Protein Therapeutics has received increasing regulatory attention due to the correlation of aggregates and particles in protein therapeutics with immunogenicity. Recent FDA-Industry meetings have focused on the need for analysis of particulates smaller than the size range measured by the USP Light Obscuration test and the instrumentation available to perform such testing.
This webinar will discuss the current regulatory requirements for testing protein therapeutics for particulates, followed by a discussion of various available methods including the simplest QC friendly techniques such as SDS-PAGE to characterization methods such as Analytical Ultracentrifugation, Field Flow Fractionation and Laser Diffraction. The instrumentation available, the advantages and disadvantages of these methods will be discussed.
Areas Covered in the Seminar :

  • Current Regulatory requirements for testing particulates in protein Therapeutics.
  • The limitations of the USP methods for testing Particulates.
  • What are the methods available for analysis of subvisible particles in protein therapeutics?
  • Comparison of size ranges, sensitivity limits and capabilities of the various methods.
  • Equipment available for performing these tests.
  • Advantages and disadvantages of the methods.

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