SC5: Introduction to Host Cell Proteins: Analysis, Characterization, Risks, and Requirements
MONDAY AUGUST 13 9:00 – 11:30 AM

Course Description:

Host cell proteins (HCPs) are a unique and complex impurity present during the production of every recombinant protein therapeutic and are critical to understand for patient safety and product efficacy. Learn about the rapidly evolving technologies and health authority expectations for HCP characterization, and how to develop and characterize HCP immunoassays at different phases of clinical development. We will also cover recent updates on recommendations, best practices and guidances for HCPs, as well as how to take a holistic approach to understanding HCPs in your process.

Topics to be Covered:

This short course will provide an overview of how to monitor and HCPs during biopharmaceutical development. We will cover how to develop effective immunoassays and demonstrate reagents are suitable for HCP monitoring at all phases of development. This will include reagent generation and characterization, as well as the use of orthogonal methods, such as mass spectrometry for HCP characterization in product-containing samples. Additionally, this course will cover overall HCP control strategy from Phase 1 through commercialization, and we will review case studies of patient exposures to HCPs.

Why You Should Attend this Course:

  • Gain insight into new technologies used to monitor, identify, and quantify HCPs
  • Stay current on health authority expectations and recently published pharmacopeial guidance on HCPs
  • Understand the importance of HCP risk assessment and how to apply to internal programs

Instructor Bio:

Denise_KrawitzDenise Krawitz, PhD, Principal Consultant, CMC Paradigms, LLC

With over 15 years of strategic and technical CMC development experience, Dr. Krawitz provides consulting expertise to large and small biotechnology companies to move products from late-stage research to commercialization efficiently. Prior to becoming a consultant, Denise was the subject matter expert for host cell protein (HCP) strategy, and led all R&D related to HCP strategy at Genentech. This included development of HCP ELISAs, characterization of HCP ELISA reagents, CHO and E. coli proteomics, and implementation of orthogonal techniques to monitor HCPs. Additionally, Denise was responsible for setting the strategic direction for HCP management across the Genentech pipeline, including setting acceptance criteria, risk assessments, and authoring all regulatory documents. Denise has authored several peer-reviewed publications in the HCP field. Denise received her Doctor of Philosophy in Molecular and Cell Biology from the University of California, Berkeley.


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