Measurement of Residual Host Cell Protein and DNA in Biotechnology Products

Host Cell Protein Photobar
June 3, 2013 - June 4, 2013
REGISTER

Overview

Co-sponsored by: : 
the Biopharmaceutical Emerging Best Practices Association (BEBPA) and USP
Overview: 

USP and BEBPA are pleased to invite you to a new workshop designed specifically for the biopharmaceutical industry. The meeting will focus on scientific, technical, regulatory, and clinical topics surrounding host cell proteins (HCP) and residual DNA. Case studies will also be presented.

DNA Workshop Watch Dr. Wesley Workman and Dr. Judith Zhu-Shimoni discuss residual host cell proteins and DNA and the upcoming USP workshop related to this topic.

 


Topics: 
  • New analytical method technologies and challenges of current methodologies used for assessing residual HCP and DNA
  • The process and the host cell contaminants: What do we know? What should we know?
  • What don’t we know?
  • Impact of host cell contaminants on clinical safety and efficacy
  • Implementing a control system: in-process vs. Certificate of Analysis testing vs. process characterization/validation (PC/PV); purposes and what the limits should be and what they should be based upon
  • Host cell impurity profiles of biosimilars and follow-ons; requirements, comparability studies, and regulatory strategies
  • Global regulatory strategies for clinical and commercial products
  • Examples of how industry may leverage the newly released Chinese hamster ovary (CHO) genome information
Who Should Participate: 

This workshop is intended for all stakeholders (industry, regulators, and associations) interested in characterizing and measuring these molecules in biotechnology products. This includes professionals working in or with:

  • Research and development
  • Contract research organizations
  • Contract manufacturing organizations
  • Regulatory affairs
  • Quality assurance/quality control

Additional Materials

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Agenda

application/pdf iconAgenda

Registration Information

Regular Price Information: 
  • Industry—$950
  • Association/Government/Academic (AAG)—$500
Early Discount Information: 
  • Industry—$850
  • Association/Government/Academic (AAG)—$400
Early Registration Deadline: 
March 31, 2013
Group Discount Information: 
  • Industry & AAG—$700 per person
Other Registration Information: 
  • Poster Presenter—$500
  • Student (must present valid student ID)—$200

Registration fee includes full two-day program, meeting materials, continental breakfast and lunch each day, and a networking reception. Contact conferences@usp.org for details.

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