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: