SC5: Back to Basics: Optimizing Bioassay Design and Analysis
WEDNESDAY, OCTOBER 24 | 6:15 - 9:15 PM
Instructors: Sofie Pattijn, CTO, ImmunXperts
Annemie Wielant, Senior Scientist, Bioassay Development, UCB
Sylvia Janetzki, MD, President, ZellNet Consulting
Bioassays are used broadly and frequently in today’s labs to determine the potency of biopharmaceuticals by testing their effects on living cells. With the main focus commonly being set on obtainable results and data handling, the fundamentals ofproperly choosing and setting up bioassays are less frequently addressed. This course focuses on the basic questions and challenges of setting up and running bioassays. From the initial scientific question that needs to be answered with the rightassay and sample choice to basic set-up strategies that will ultimately determine the assay performance and outcome, an overview will be given of important sample handling considerations, reagent choices, critical protocol steps and available harmonizationguidelines. Challenges and pitfalls during the design of a bioassay will also be reviewed and examples of case studies will be presented.
Topics covered include:
- Assay choice
- Sample choice and sample handling considerations
- Critical reagent choices
- Available guidance for essential protocol steps
- Lab examples of bioassay design and set-up
Instructor Biographies:
Sofie Pattijn, CTO, ImmunXperts
Sofie Pattijn (CTO and founder, ImmunXperts) has over 20 years of experience in the field of immunogenicity assessment (vaccines and biotherapeutics) and in vitro assay development. She has extensive hands-on lab experience and has managed and coached several In Vitro teams over the last decade. From 2008 till 2013 she was Head of the In Vitro Immunogenicity group at AlgoNomics (Ghent, Belgium) and Lonza Applied Protein Services (Cambridge, UK). Prior to that, she worked at Innogenetics, Belgium for over 15 years.
Annemie Wielant, Senior Scientist, Bioassay Development, UCB
Annemie Wielant has a Biological and Medical European Engineer degree from the Hogeschool Brabant (The Netherlands). She joined UCB in July 2008 in the Analytical Sciences for Biologicals department. She initially worked in the physico/chemical unit before moving to the Bioassay Development group in 2011. She is now working as a Senior Scientist on the development/optimization, validation and tech transfer of CMC biological potency assays (ligand binding and cell-based assay) from preclinical phase to phase III.
Sylvia Janetzki, MD, President, ZellNet Consulting
Dr. Janetzki is founder and president of ZellNet Consulting. The focus of her work during the past 20 years has been immune monitoring approaches for clinical studies with emphasis on Elispot and sample integrity. Her work led her to a tight collaboration with the Cancer Immunotherapy Consortium (CIC/CRI), for which she initiated and lead a world-wide proficiency panel program for assays like Elispot, Multimer staining, Intracellular Cytokine Staining (ICS), Luminex and others. Multiple guidelines for harmonized assay performance have been published as a result of this work. Sylvia is the leader of the MIATA core team for the enhancement of structured and transparent reporting of immune monitoring results (miataproject.org). She is the author of numerous publications, books and book chapters, including a recent Nature Protocols publication on guidelines for Elispot evaluation. She received her MD from Humboldt University, Berlin, and her post-doctoral training in Immunology from Fordham University and MSKCC.