Quantifying Host Cell Proteins by LC-MS: Experimental Demonstration and Method Comparison in USP 1132.1

Register Free: https://www.biopharminternational.com/bp_w/experimental-demonstration

Event Overview:

The demand for orthogonal methods providing detailed information on individual HCPs has increased. This has culminated in the establishment of the new USP-NF Chapter 〈1132.1〉 Residual Host Cell Protein Measurement in Biopharmaceuticals by Liquid Chromatography-Mass Spectrometry, which outlines 3 methods for quantifying HCPs using mass spectrometry (MS). HCP analysis by MS is complex, expensive, and necessitates skilled professionals for setup and operation, and its implementation can pose significant challenges. This raises the question: how can these methods be integrated into practical testing, and what are the advantages, disadvantages, and potential pitfalls of each method?

Key Learning Objectives:

• Understand the 3 quantitative methods that can be used to assess HCPs in a biotherapeutics:
  a)relative to the product protein,
  b) relative to spiked-in proteins, and
  c) relative to the spiked-in peptides.
  
• Learn the benefits of each method.

Who Should Attend:
Director, Manager, Head of, Scientist of:

• mAb development or manufacturing
• CMC analytical method development
• Process analytics (biologics)
• Quality control / assurance / testing
• Protein sciences
• Translational research scientist
• Mass spectrometrists

Speakers:

Derrick Zhang, MSc
Senior Scientist II
USP

Derrick Zhang, MSc, is a senior scientist II at US Pharmacopeia, leading the development of reference standards and analytical reference material for biologics. In his previous roles at Adaptive Phage Therapeutics, he oversaw the analytical development and qualification of potency and characterization assays, including LC/MS and ELISA for host cell protein analysis for drug substance (DS) release. At United Therapeutics Corporation, he managed assay development for DS characterization, including validation of process-specific HCP-ELISA for GMP release testing.

Victor Chrone, MSc
Bioinformatics Scientist
Alphalyse

Victor Guldmann Chrone is a bioinformatics and protein scientist at Alphalyse. He holds a master’s degree in computational biomedicine from the University of Southern Denmark, where he focused on the structural characterization of monoclonal antibodies using cross-linking liquid chromatography–tandem mass spectrometry (LC-MS). Chrone’s research concentrates on bioinformatics on host cell protein and quality control when utilizing LC-MS. He has extensive experience in LC-MS-based proteomics, data mining, machine learning, and data visualization.

Register Free: https://www.biopharminternational.com/bp_w/experimental-demonstration