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Webinar

Redefining Antibody Specificity Profiling for IND

ET
60 minutes

Assessment of antibody off-target reactivity is a regulatory requirement for clinical development. However, conventional screening methods, such as tissue cross-reactivity studies, are often ineffective in screening newer therapeutic modalities, and their predictive value for in vivo safety and toxicity is poor. So, what are the alternatives?

Join our webinar to learn about the new, innovative cell-based protein array approach to specificity profiling. We’ll take a deep dive into the Membrane Proteome Array (MPA), a 6,000-protein array platform that tests binding of biotherapeutics across the full human membrane proteome expressed in unfixed cells. 

Attendees will learn about: 

  • How the MPA can be used to rapidly and accurately identify potential off-target binding liabilities 

  • Ways MPA data support both lead selection and IND submissions, with a look at the advantages over tissue cross-reactivity studies 

  • The rapid progression of cell protein arrays towards FDA endorsement, including a deep dive into the inclusion in CAR-T development guidelines and qualification as an antibody Drug Development Tool 

  • And more 

Speakers

integral

Kris Raghavan, PhD

Kristopher Raghavan is an Application Scientist at Integral Molecular, specializing in the Membrane Proteome Array. Since joining in 2022, he has been instrumental in establishing the MPA as the leading solution for antibody specificity profiling. Kristopher offers technical support, manages projects, and analyzes data for customer projects. He earned his Ph.D. from Drexel University in 2021.

integral

Diana Norden, PhD

Diana Norden is a Senior Scientific Writer at Integral Molecular. Her work primarily focuses on regulatory development and applications of the Membrane Proteome Array. She has written extensively on current standards and best practices for antibody specificity profiling, and recently co-authored a chapter on biotherapeutic specificity testing (Testing for Off-target Binding) that was published in Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals. Diana earned her Ph.D. from The Ohio State University in 2015.

Register here!

Date/Time:
ET
Duration:
60 minutes