Bioassay Development and Immunogenicity Testing in a Regulated Environment

Tuesday 8 October 2019 12:30 - 17:30


Attendance at this event is complimentary

 

This event is mainly targeting protein and antibody researchers, bioanalysis research scientists and research groups with an interest in precision medicine, translational oncology and biomarkers.

Please note, all registrations are subject to the approval of the sponsor and registrations cancelled if they are not considered to meet the above criteria.  You will be informed if your registration has been cancelled within 2 working days of registering online for this event.

 

Email Alicia for further information.

 

Bioassay development and Immunogenicity testing for biologics are important considerations for drug development companies when it comes to ensuring the efficacy and safety of a therapeutic proteins. 

 

A key method of evaluating immunogenicity involves detection and analysis of anti-drug antibodies (ADAs) and an understanding of antibody behavior.  Validated methods of assessing immunogenicity and bioassays for PK/TK are a key part of the drug development process and also an expectation of regulatory bodies.   

 

Celerion and One Nucleus are hosting an Innovation Seminar which will look at the challenges faced in the biotech industry in regard to bioassay development and immunogenicity testing. Leaders working in bioanalytical and bioassay development will come together to provide case studies and best practices for handling the most common issues in biological assay development, validation, transfer, and regulatory considerations.

 

Programme:

12:30 Registration and lunch

13:00 Welcome by One Nucleus and Celerion

13:10 Introduction
Keynote: Dr Scott Summerfield, Senior Director and WW Head of Bioanalysis, GSK

13:30 Challenges in Bioanalytical Assay Development 
Dr Patrick Brennecke, Technical Director Bioanalytical Translational Science, Celerion

14:00 A few surprising things about immunogenicity
Dr Geoff Hale, Company Director, The Native Antigen Company, Absolute Antibody, BioArchitech

14:30 Break coffee/tea/networking

15:00 An Integrated Approach to Managing Immunogenicity Risk and Optimum Protein Design
Dr Jeremy Fry, Director, ProImmune

15:30 Case Study: Successfully Navigating an FDA Immunogenicity Audit
Rafiq Islam, Executive Director, Celerion

16:00 Q&A with speaker panel

16:30 End of session, Networking / Drinks  

17:30 Close

 


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When
October 8th, 2019 from 12:30 PM to  5:30 PM
Location
Cambridge Building
Babraham Research Campus
Cambridge, Cambridgeshire CB22 3AT
United Kingdom
Contact
Phone: 01223 896450
Phone: 01223 896456