Cambridge Healthtech Institute’s 7th Annual

Host Cell Proteins

Strategies and Technologies for Detection, Analysis and Control

August 15-16, 2022

 

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 Host Cell Proteins conference brings together industry leaders to discuss the evolution of analytical methods, standards, and control strategies in this dynamic space and to consider emerging understandings of the impact of specific high-risk HCPs.

 

Coverage will include, but is not limited to:

 

Control Strategies

  • Impurity affinity binding as a control step
  • ELISA strategies for HCP control, multiple v. generic
  • Upstream prediction and control of HCPs in production cell lines

 

Emerging Characterization Methods

  • Novel HCP characterization workflows
  • Synthetic chemical probes
  • Targeted parallel or multiple reaction modeling (PRM/MRM)

 

High-Risk Host Cell Proteins

  • Binding studies for specific HCPs
  • Knockout cell lines for HCP control
  • Quantification levels for high-risk HCPs

 

LC-MS In HCP Detection and Control

  • Comparing ELISA and LC-MS methods
  • LC-MS to study comparability after a process change
  • QC perspective on transitioning LC-MS to QC/GMP environment

 

Monitoring and Controlling HCPs in New Modalities

  • Adapting analytical platforms to new modalities
  • Case studies: cell therapy, vaccine, mRNA
  • Method development

 

Problems and Solutions

  • Analytical support for continuous release
  • Best practices for internal development of HCP monitoring kits
  • FDA/international regulatory updates
  • Low abundant HCP detection
  • Phase appropriate risk assessment and CQAs
  • Risk assessment for high dose biotherapeutics

 

The deadline for priority consideration is February 4, 2022.

 

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-K

Sherry Johnson

Sr. Business Development Manager

Cambridge Healthtech Institute

Phone: +1 781-972-1359

Email: sjohnson@healthtech.com

 

Companies L-Z

Jon Stroup

Sr. Business Development Manager

Cambridge Healthtech Institute

Phone: +1 781-972-5483

Email: jstroup@healthtech.com


Submit a Speaker Proposal