BEBPA PRESENTS:

6th Annual BEBPA HCP Conference

May 14-16, 2018
Dubrovnik, Croatia

SPEAKERS

Abstracts (Alphabetical by Speaker/Presenter)

It’s all about the Quality of the Material, Developing Optimal HCP Immunoassay Critical Reagents

  • Speaker: Jessica Campbell, Pfizer
  • Abstract: (Pending)
  • (Day 1: Anti-HCP Antibody Characterization Session)

Comparison of Common Approaches to Generation of AntiHCP Antibody Reagents

  • Speaker: Murty Chengalvala, Covance
  • Abstract: (Pending)
  • (Day 1: Generation of High Quality Anti-HCP Antibodies Session)

European Pharmacopoea HCP Chapter

  • Speaker: Gwenaël Cirefice, EDQM-Council of Europe
  • Abstract: (Pending)
  • (Day 1: Health Authority Considerations Session)

Mass Spectrometry Brightening the HCP ELISA Results Black Box

  • Speaker: Séverine Clavier, Sanofi R & D
  • Abstract: (Pending)
  • (Day 2: Mass Spectrometry as an Orthogonal Method Session)

Applying Platform Knowledge and Risk Assessment Tools to Define HCP Strategy for a Gene Therapy Program

  • Speaker: Carl Co, Biogen
  • Abstract: (Pending)
  • (Day 1: HCPs for Non-Antibody Products Session)

HCP Risk Assessment

  • Instructor: Christina de Zafra, Amgen
  • Abstract: (Pending)
  • (Workshop 2-AM)

Design of Experiment (DOE) Based Approach for Defining Critical Parameters in Host Cell Protein Analytical Method Development and Validation

  • Speaker: Joachim Dietenberger, Boehringer Ingelheim
  • Abstract: (Pending)
  • (Day 2: Reagent and Assay Lifecycle Management Session)

Host Cell Protein Clearance in Downstream Purification Processes: Lessons Learned and Future Considerations

  • Speaker: Jayme Franklin, Genentech
  • Abstract: (Pending)
  • (Day 1: Process Development Perspectives on HCP Monitoring Session)

Regulatory Aspects and the Pitfalls Regarding HCP Analysis and Documentation

  • Speaker: Erika Friedl, Paul Erlich Institute
  • Abstract: (Pending)
  • (Day 1: Health Authority Considerations Session)

Same but Different: A Case Study of HCP Comparability for an In-Licensed Project

  • Speaker: Feny Gunawan, Genentech
  • Abstract: (Pending)
  • (Day 2: Reagent and Assay Lifecycle Management Survey)

Protein-Centric ELISA Reagent Coverage Evaluation by Affinity Purification Mass Spectrometry

  • Speaker: Scott Henry, Seattle Genetics
  • (Day 1: Anti-HCP Antibody Characterization)

HCP Profiling and Lipase Monitoring for DNA Derived Biopharmaceuticals by LC/MS/MS

  • Speaker: Lihua Huang, Eli Lilly
  • Abstract: (Pending)
  • (Day 2: Mass Spectrometry as an Orthogonal Method Session)

Absolute Quantification of Host Cell Protein by SWATH LC-MS/ MS towards Method Validation and Batch Release Testing

  • Instructors: Thomas Kofoed, Alphalyse
  • Abstract: (Pending)
  • (Day 2: Cutting Edge MS Technology for ID of HCPs Session)

Making LC-MS for HCP Reliable: Challenges from Sample Preparation to Data Analysis

  • Speaker: Nicolas Lebesgue, Novartis
  • Abstract: (Pending)
  • (Day 2: Mass Spectrometry as an Orthogonal Method Session)

Lipoprotein Lipase is a Difficult to Remove HCP: Studies from the 2018 Reference Genome

  • Speaker: Kelvin Lee, University of Delaware
  • Abstract: (Pending)
  • (Day 1: Opening Keynote Talk)

Looking for a Needle in a Haystack: Characterization and Quantification of the Host Cell Proteome in Drug Substances by a Novel 2D LC- MSe Approach

  • Speaker: Benedetta Lombardi, Merck
  • Abstract: (Pending)
  • (Day 2: Cutting Edge MS Technology for ID of HCPs Session)

Replacement of HCP Assay for a Marketed Product

  • Speaker: Stanislav Mandelc, Sandoz/Novartis
  • Abstract: (Pending)
  • (Day 2: Reagent and Assay Lifecycle Management Session)

HCP Specification Setting

  • Speaker: Ned Mozier, Pfizer
  • Abstract: (Pending)
  • (Workshop 2-PM)

Assessing Immunogenicity Risk in Biotherapeutic Products and Process Development

  • Speaker: Valarie Quarmby, Genentech
  • Abstract: (Pending)
  • (Day 1: Health Authority Considerations Session)

Characterization, Optimization and Application of an LC-MS based Workflow for HCP Identification, Quantification and Control

  • Speaker: Michael Schrim, Caprion
  • Abstract: (Pending)
  • (Day 2: Cutting Edge MS Technology for ID of HCPs Session)

Generation of High Coverage Anti-HCP Polyclonal Antibodies: Is Coverage of HCPs Impacted by Animals?

  • Speaker: Christina Seisenbeger, Roche
  • Abstract: (Pending)
  • (Day 1: Generation of High Quality Anti-HCP Antibodies Session)

The Challenges of Developing HCPs Methods for Vaccines – Risk Based Approach to HCP Monitoring

  • Speaker: Lee Smith, GreyRigge Associates, Ltd
  • Abstract: (Pending)
  • (Day 1: HCPs for Non-Antibody Products Session)

Advanced Mass Spectrophotometry Analysis of HCPs

  • Speaker: Martha Staples, Genzyme
  • Abstract: (Pending)
  • (Workshop 1-PM)

Host Cell Protein Considerations for Cell Culture Process Development

  • Speaker: TBD
  • Abstract: (Pending)
  • (Day 1: Process Development Perspectives on HCP Monitoring Session)

HCP Biological Activity Impact on Product Quality/Stability (Protein or Polysorbate)

  • Speaker: TBD
  • Abstract: (Pending)
  • (Day 1: Process Development Perspectives on HCP Monitoring Session)

Beginning Mass Spectrophotometry Analysis of HCPs

  • Speaker: Kevin Van Cott, University of Nebraska
  • Abstract: (Pending)
  • (Workshop 1-AM)

Challenges and Lessons Learned in Implementing an In-House CHO Platform HCP Assay for Process Characterization

  • Speaker: Fengqiang Wang, Merck Sharp & Dohme
  • Abstract: (Pending)
  • (Day 2: Reagent and Assay Lifecycle Management Session)

HCP Antibody Purification from CHO K1SV Antisera for Broad HCP Coverage from BMSCHO Cell Line

  • Speaker: Lei Zhang, Bristol-Myers Squibb
  • Abstract: (Pending)
  • (Day 1: Anti-HCP Antibody Characterization Session)