APR 08, 2015 7:00 AM PDT

Introduction to the new USP <787>: "Subvisible Particulate Matter in Therapeutic Protein Injections"

Speakers
  • Life Science Application Manager, Beckman Coulter, Particle Counting and Characterization
    Biography

      Currently the Life Science Application Manager at Beckman Coulter Life Sciences, PCC (Particle Counting and Characterization) (formerly part of Hach), Joe has been involved with the particle counting industry since 1984.  First joining Met One as an electronic design engineer, Joe has been involved in both airborne and liquid particle counter design, as well as multi-sensor systems for facility monitoring systems (FMS).  Joe has been involved in various standards involving particle counting in air and liquids.  He is part of the TC209 WG1 revision group on the main global cleanroom certification standard, ISO 14644-1 and -2, one of the two Americans on the committee. He is also involved with the ISO TC24/SC4 committees related to use and calibrations of various particle counting and characterization instruments.  In recent years, Joe has been giving information seminars in Asia, Europe and South America on particle counting and associated topics such as

      •    FDA enforcement
      •    Electronic Records and Signatures (21CFR Part 11)
      •    The change-over from FS 209E to ISO 14644-1 for room certification
      •    EU Annex I – controversies regarding airborne particle counting
      •    Changes to EP Injections regarding counting particles in final liquid injectables
      •    Determining Sampling positions in designing an FMS or fixed monitoring system
      •    Planning a strategy for Analytical Instrument Qualification (AIQ)

      Joe was originally a native of southern California, receiving a B.S.E.E. (Electrical Engineering) from UC Santa Barbara in 1976.  He has called southern Oregon home since 1981.


    Abstract:
    This educational session will focus on some of the new demands in counting particles in liquids, with a focus on the challenges of preparing and sampling protein-based materials. USP has recently posted a new test for protein-based materials, known as USP <787>, and indicated that a companion informational chapter, USP <1787>, will be crafted to further describe methods and options for evaluating protein-based materials. This presentation will delineate the differences between the more well-known USP 788 and the new USP 789, focusing on critical sample preparation and handling to provide good data on particulate concentration in protein solutions. Two types of instruments that could be employed for this method are discussed and compared, one based on light obscuration and a second on the Coulter principle.

    Learning Objectives:
    • Learn about the new demands in counting particles in liquids, with a focus on the challenges of preparing and sampling protein-based materials
    • Learn about the new test USP has recently posted for protein-based materials, known as USP <787>
    • This presentation will delineate the differences between the more well-known USP 788 and the new USP 789, focusing on critical sample preparation and handling to provide good data on particulate concentration in protein solutions
    • Learn about and compare two types of instruments that could be employed for this method, one based on light obscuration and a second on the Coulter principle

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