Bioassays & Bioanalytical Method Development Session Spotlight: Anticipating and Assessing the Immunogenicity of Biologics—A Scientific and Regulatory Perspective

Cell-based assays are extremely challenging to use due to their innate uniqueness and the need to interpret them through complex statistical analysis programs. At the same time, FDA regulators often require the use of a NAb assay in order to test immunogenicity and demonstrate product safety – meaning this is a challenge that practitioners in this field cannot avoid. In this session Dr. Martin Lechmann, Associate Director of DMPK at Merck Serono, will provide specific case studies of methods to decrease the development time of these assays, while also increasing robustness, reproducibility, and potential for automation.

For more information on Bioassays and Bioanalytical Method Development, download the agenda.  If you'd like to join us in Berkeley, CA this October 1-3, 2012, as a reader of this blog when you register to join us and mention code XP1768BLOG, you'll save 15% off the standard rate!

Featured Session: Novel Approaches for the Detection of Neutralizing Antibodies
Featured Speaker: Martin Lechmann, PhD,Associate Director, DMPK, MERCK SERONO
About the Session: The development of reliable Nab assays is very challenging and takes a lot of time and resources until a validated NAb assay is up and running. Usually not only the development time is long but also the assay itself can last several days. Thus, cell-based Nab-assays are in general not suitable to analyze high number of samples. In addition, cell-based Nab assays are often susceptible to matrix background and special care has to be taken to assure that the neutralizing effects are attributed to antibodies. Particularly, robustness and reproducibility present major challenges. Therefore, new approaches are needed to decrease the development time and to increase the reproducibility of these assays. We will present different novel approaches with the aim to develop NAb assays that are more robust and have the potential for automation. These approaches include miniaturization of cell cultivation using Lab-on-Chip Technology and ready to assay cells.

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