Cambridge Healthtech Institute’s 6th Annual

Host Cell Proteins

Detection, Analysis and Control<

August 16-17, 2021

 

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 and to consider emerging understandings of the impact of specific proteins.

 

Coverage will include, but is not limited to:

 

Challenges and Solutions

  • HCP issues with transferred and inlicensed programs
  • Monitoring anti-HCP antibodies in clinical samples
  • Setting suitability and qualification criteria for HCP ELISA assays

Control Strategies

  • Downstream flowsheets for HCP fate
  • HCP control indexing
  • Impurity capture strategies

Emerging Technologies

  • Computer modeling for HCP profiling, detection and control
  • Emerging instruments for the QC lab
  • Impurities characterization for cell and gene therapies

LCMS in HCP Detection and Control

  • Alternatives to LCMS as a characterization tool
  • How can LCMS be used as a release method?
  • Software and data management challenges for MS methods

Profiling and Controlling High-Risk HCPs

  • Bridging from a broad kit to a process specific reagent
  • Case studies of how to develop an HCP profile
  • Update on BPOG risk assessment framework

Regulatory and Standards Issues

  • EMA and FDA agency perspectives on process specific assays and monitoring
  • Industry perspectives on HCP detection/control regulatory discussions
  • Update on USP MS quantitation chapter

 

If you would like to submit a proposal to give a presentation at this meeting, please click here.

 

The deadline for priority consideration is January 29, 2021.

 

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 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.

 

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 partnering and sponsorship information, please contact:

Companies A-K

Sherry Johnson

Senior Manager, Business Development

Cambridge Healthtech Institute

Phone: (+1) 781-972-1359

Email: sjohnson@healthtech.com

 

Companies L-Z

Jon Stroup

Senior Manager, Business Development

Cambridge Healthtech Institute

Phone: (+1) 781-972-5483

Email: jstroup@healthtech.com


Speaker Proposal