Assessment and Control of the Effector Functions of Therapeutic Antibodies
Position Paper Co-Authored by Members of Working Group Representing MedImmune, Genentech, Biogen Idec, Merck, Eli Lilly, and Amgen

Attend the 2012 conference and get the details first-hand from Svetlana Bergelson, Ph.D., Associate Director at Biogen-Idec who will present the white paper on Tuesday, May 1, 2012.

The presentation will provide an overview of the white paper on Fc effector function of therapeutic antibodies published in February 2011 (Nature Reviews Drug Discovery 10, 101-111). A summary of the current knowledge of antibody Fc functionality, a strategy for assessing the effector functions of different classes of therapeutic antibodies (including Fc fusion proteins) and a proposed path for routine testing and controls for manufacturers of antibody products will be covered.

Balancing the Statistical Tightrope
By Lee C. Smith

The 2011 Bioassay conference featured a presentation by Lee Smith on this same topic. His presentation discussed the development of assays from the development scientist's perspective with examples of how to get the balance right when developing complex assays by applying practical experience, emerging statistical tools and just plain common sense. You can read his paper to learn more on this topic or download a copy of his presentation.

An ADCC Assay for Quality Control Development, Long-Term Performance & Fine Tuning
Alfred Schnueriger, Group Head, F. Hoffmann-La Roche AG, Basel Switzerland

ADCC assays are considered a mainstay of the matrix of bioassays for Monoclonal Antibodies. Or are they? They are highly variable biological assays with no hope of meeting current regulatory expectations. Or are they? Last year, Dr. Schnueriger convinced meeting attendees that at least some ADCC assays, those which can use an NK cell line, can meet regulatory expectations. (See the attached slides) Now this year, Drs. Bergelson and Jiang will discuss when ADCC assays are needed and for what subtype of mAb products.