Cambridge Healthtech Institute’s 8th Annual

Host Cell Proteins

Strategies and Technologies for Detection, Analysis and Control

August 14-15, 2023

 

Characterizing and controlling process-related impurities, such as host cell proteins (HCPs), is a critical part of bioprocessing, with regulators now pressing companies for more data and questions emerging on the role of HCPs in emerging modalities. CHI’s 8th Annual Host Cell Proteins conference brings together industry leaders to discuss the evolution of analytical methods, regulatory impacts, standards, and control strategies in this dynamic space.

 

Coverage will include, but is not limited to:

 

HCP Characterization & Control for New Modalities

  • Adaptation of HCP analytical platforms to new modalities
  • Impact of HCPs on complex engineered proteins
  • Risk assessment and HCP characterization/control for AAV and mRNA

Progress in Replacing ELISA with LC-MS in QC

  • Best practices for validation of LC-MS assays
  • Case studies of regulatory filings with only LC-MS data
  • New QC-friendly MS methods

Emerging Methods & Instruments

  • Data independent analysis (“DIA”) methods for low concentration HCPs
  • LC-MS methods with improved throughput and sensitivity 
  • Strategies for enhancing HCP coverage analysis (native, affinity-based)

Product Quality & In-Process Controls

  • CQA assays for host cell proteins
  • High throughput downstream control strategies for low abundance HCPs
  • Upstream strategies for process and product specific HCP characterization

Regulatory & Standards Impacts

  • FDA perspectives on release assays, coverage assessment 
  • HCP-related tech transfer considerations for international markets
  • Updates on new USP chapter and physical standards

Problems and Solutions

  • Development of process-specific assays and reagents
  • Immunogenicity prediction profiles
  • Measuring activity from residual host cell enzymes
  • Measuring impact of process changes on HCP profile
  • Modeling and machine learning in HCP characterization and control

 

The deadline for priority consideration is February 3, 2023.

 

All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute’s policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

 

Opportunities for Participation:

 

 

For more details on the conference, please contact:

Kent Simmons

Senior Conference Director

Cambridge Healthtech Institute

Phone: (+1) 207-329-2964

Email: ksimmons@healthtech.com

 

For sponsorship information, please contact:

Companies A-M

Phillip Zakim-Yacouby

Senior Business Development Manager

Cambridge Healthtech Institute

Phone: (+1) 781-247-1815

Email: philzy@cambridgeinnovationinstitute.com

 

Companies N-Z

Aimee Croke

Business Development Manager

Cambridge Healthtech Institute

Phone: (+1) 781-292-0777

Email: acroke@cambridgeinnovationinstitute.com