EBF
EBF Focus
Focus
EBF - Focus Workshop
Current analysis of immunogenicity – Best Practices and Regulatory Hurdles
Altis Grand Hotel
Lisbon, Portugal
27-28 September 2016

General EBF

General info on the EBF can be found on http://www.europeanbioanalysisforum.eu/

AIM OF THIS IMMUNOGENICITY FOCUS WORKSHOP

The importance of immunogenicity assessment and anti-drug antibody (ADA) assay validation and analysis is an integrated part of the drug development program for large molecules. Certainly, the updated guideline from EMA and FDA earlier this year has put an additional spotlight on the need for the industry to continue the discussion. In support of that discussion, the EBF is organising a Focus Workshop (FW) to connect the news in regulatory requirements on assay validation and analysis with the recent experiments of past recommendations in industry.

 

The aim of the Workshop is to share current practices in drug R&D related to immunogenicity assay validation and analysis. At the Workshop, we want to provide the delegates a better understanding of current day-to-day challenges in immunogenicity analysis as well as discuss current status of experiences of “best practice” implementation introduced some years ago. Also, we plan to connect the analytical experiences with the recent updates of the EMA and FDA immunogenicity guidelines.

 

Although the agenda is still being drafted, we are planning the workshop to consist of 3 parts

  1. Introduction: current status of immunogenicity assay validation, analysis and regulation.
  2. Workshop discussions: discuss current guideline updates and a number of real life examples of immunogenicity assay challenges. Examples are but not limited to:

. Discussion on new – draft Guidances (EMA/FDA)
. Cut-point setting in ADA assays
. Improvement of drug tolerance – experiences on acid dissociation
. Critical reagents in immunogenicity assays

  1. Conclusions: feedback from the examples and proposed way forward