Best Practices for Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry: USP Chapter <1132.1>

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Webinar Date/Time: Wed, May 31, 2023 11:00 AM EDT

Mass spectrometry has become an increasingly common approach for identification and quantitation of HCPs to support risk assessment and process development as well as characterization and quality control. This presentation will provide an overview of USP’s proposed General Chapter <1132.1> Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry.

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Event Overview:

Protein-based biotherapeutics are produced by numerous prokaryotic and eukaryotic cellular expression systems. During the manufacture of these products, host cell proteins (HCPs) are a significant class of process-related impurities that are coproduced with the desired product. USP General Chapter <1132> Residual Host Cell Protein Measurement in Biopharmaceuticals includes detailed information on the design, validation, and implementation of reagents and immunoassays used to measure these residual HCPs. A new proposed chapter builds on <1132> and provides an overview of the capability of Mass Spectrometry (MS) methods for HCP identification and quantitation. This seminar will describe best practices for instrument selection, sample preparation, liquid chromatography (LC) separation, MS data acquisition, MS data analysis and reporting, with particular attention to the orthogonality of MS and traditional methods.

Key Learning Objectives

  • To understand the importance of Host Cell Protein Analysis in biopharmaceutical development.
  • To become familiar with current technologies and best practices for analysis of HCP by LC-MS
  • To understand the applications for and orthogonal relationship of LC-MS and traditional methods for HCP analysis.

Who Should Attend

  • Scientists, managers and regulatory experts responsible for manufacture and testing of biologics destined for clinical trials.


Niomi Peckham
Director of Pipeline Development, Global Biologics
United States Pharmacopeia

Niomi Peckham is the Director of Pipeline Development in USP Global Biologics. She works with scientific experts and stakeholders to develop standards for assays used to support biopharmaceutical quality assessment and development. Niomi has worked for several biotechnology and diagnostic companies but has spent most of her career at Pfizer and Alexion Pharmaceuticals, focusing on development of protein-based biopharmaceuticals. She has been responsible for development, validation, transfer, and lifecycle management of analytical methods for biopharmaceuticals from pre-clinical through commercialization. Her particular focus has been on analysis of host cell proteins.

Niomi holds a Bachelor of Science in Biotechnology from the University of Connecticut, a Master of Science in Molecular and Cellular Biology from the State University of New York at Stony Brook, and a Graduate Certificate in Drug Development from Temple University.

Ned Mozier
Vice President, Biotherapeutics Pharmaceutical Sciences

Ned Mozier group is responsible for CMC teams for 40-50 projects in Pfizer clinical trials, including the coordination of authoring and reviewing of regulatory submissions to assure on-time delivery. This group is responsible for BTxPS committees that manage the early projects entering Pfizer’s pipeline and resolve key project conflicts and authorize critical strategies. Achievement of key milestones (within budget and on time) as well as risks of delay or major budget change are communicated proactively. Milestone goals and achievements are tracked for all standard, accelerated, and Lightspeed projects. His group manages the internal manufacturing capacity as well as the outsourcing function, in which smooth transitions of projects from early to later stages are a priority. Project leadership and management from this group contributes to Pfizer’s mission of delivering 25 breakthrough products to patients by 2025. The transfer of out-licensed projects is also managed in collaboration with the Transformative Technology group.

Ned obtained his Ph.D. in biochemistry from the University of Louisville in 1988, which prepared him for a career in the biotechnology sector. After postdoctoral research at The Upjohn Company and two years at Baxter Healthcare’s blood substitutes division, Ned has worked for Pfizer and legacy companies. He has led co-development projects and contributed to many approved products, including establishment of the structure function relationships for biosimilars.

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