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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An Exclusive Interview about Immunogenicity from Dr. Martin Lechmann of Merck Serono

The 13th annual Immunogenicity for Biotherapeutics conferenceis devoted to offering you the most pressing and timely knowledge about designing safer biologics.

As part of this ongoing commitment to our audience, we are pleased to announce an exclusive interview with Dr. Martin Lechmann, Associate Director for Bioanalytics, Immunogenicity, and DMPK, Non-Clinical Development, at Merck Serono.

Dr. Lechmann’s interview addresses potential pharmacokinetic and pharmacodynamic biomarkers for immunogenicity, mechanisms for improving drug tolerability, immunoassay reliability, and other major concerns now facing the industry. Please click here to download the interview.

Download Dr. Lechmann’s podcast here.

Here's an excerpt from the article:

Now, can we delve into that a little bit? What are some of the challenges that are involved in using PD activity as a biomarker for immunogenicity? If they can be overcome, what are the specific benefits?

Dr. Lechmann's response: Yes, of course. First of all, you have to have an appropriate biomarker in your hands. In many cases, it is very difficult to achieve this. Of course, then if you have the biomarker, you have to have a very good understanding of the biology of the biomarker and to see if it is an early biomarker or late biomarker. And furthermore, it’s very crucial, also, to see how you determine what the kind of assay is to determine the concentration of the biomarkers. So, the capability of the biomarker. I think these are the challenges that you face with PD markers.

Immunogenicity for Biotherapeutics can help you find more answers about designing worthwhile assays and safer molecular configurations. To find out more about the event, download the brochure.

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