European Immunogenicity Platform 11th Open Scientific Symposium on immunogenicity of biopharmaceuticals

Author:

Tourdot Sophie1,Quaglia Carolina B2,Chamberlain Paul3,De Groot Anne S4,Dellas Nikki5,Guillemare Eric6,Kromminga Arno7,Lotz Gregor P8,Mingozzi Federico9,Piccoli Luca10,Pine Samuel11,Richards Susan12,Waxenecker Günter13,Kramer Daniel14

Affiliation:

1. BioMedicine Design, Pfizer Inc., Andover, MA 01810, USA

2. Immunoinformatics & Machine Learning, Technical University of Denmark, Kgs, Lyngby 2800, Denmark

3. NDA Advisory Board, NDA Regulatory Science Ltd., Leatherhead KT229DF, United Kingdom

4. EpiVax, Providence, RI, USA & University of Georgia, Athens, GA 02909, USA

5. Codexis, Redwood City, CA 94063, USA

6. Translational Medicine & Early Development – Sanofi Montpellier, Montpellier 34184, France

7. Bioagilytix, Hamburg 22339, Germany

8. Roche Pharma Research & Early Development, Large Molecule Bioanalytical Sciences, Roche Innovation Center, Penzberg 82377, Germany

9. Spark Therapeutics, Philadelphia, PA 19104, USA

10. Institute for Research in Biomedicine, Università della Svizzera italiana, Bellinzona 6500, Switzerland

11. Bioanalysis & Immunogenicity, Ablynx NV, a Sanofi Company, Zwijnaarde 8052, Belgium

12. Sanofi-Genzyme, TMED, Framingham, MA 01701, USA

13. Austrian Medicines & Medical Devices Agency, Department of Biologicals, Preclinical & Statistical Assessment, Vienna 1200, Austria

14. Sanofi R&D, Translational Medicine & Early Development, Frankfurt am Main 65926, Germany

Abstract

Given the expanding number of complex therapeutic protein drugs and advanced therapy medicinal products that are being developed, improving our ability to assess the potential immunogenicity of biologics is critical to ensuring treatment efficacy and patient safety. In this context, the European Immunogenicity Platform annual meeting provides opportunities for experts from industry and academia, regulators and clinicians to convene and discuss immunogenicity assessment methods and tools. This report summarizes the key messages on immunogenicity testing, prediction, clinical relevance and advanced therapy medicinal products discussed at the 11th Open Scientific European Immunogenicity Platform Symposium on Immunogenicity of Biopharmaceuticals, Lisbon, Portugal, 17–19 February 2020.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Reference17 articles.

1. Current Considerations on Characterization of Immune Response to Multi-Domain Biotherapeutics

2. An innovative method for characterizing neutralizing antibodies against antibody-derived therapeutics

3. European Medicines Agency. Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. ICH Guideline S6 (R1) (2011). https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s6r1-preclinical-safety-evaluation-biotechnology-derived-pharmaceuticals-step-5_en.pdf

4. Immune camouflage: Relevance to vaccines and human immunology

5. Better Epitope Discovery, Precision Immune Engineering, and Accelerated Vaccine Design Using Immunoinformatics Tools

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