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Solving complex immunogenicity challenges

Immunogenicity assessment is a critical safety attribute for biotherapeutics undergoing clinical development. Developing clinically relevant immunogenicity assays is an essential element for providing a route for successful submission. This webinar will discuss some of the challenges faced during the development of immunogenicity methods, as well as present some solutions for resolution of those issues. Our panelists will discuss three different case studies that have been utilized to demonstrate the importance of tailoring the development process to the drug and clinical study requirements.

What will you learn?
  • Hear about three unique ADA case studies and challenges associated with the development process.
  • Learn the importance of tailoring assay development process to both the drug and the clinical study requirements.
  • Find out a few tools to assist in tackling drug and target tolerance in ADA assays.
Who should attend?
  • Anyone involved in large molecule bioanalysis.
  • Bioanalytical method developers from CRO and Pharma environment.
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Agata Michalak

Agata Michalak

Research and Development Manager, Agilex Biolabs

Agata has over 18 years of experience in bioanalytical and diagnostic industry, having worked across Europe and Australia.

At Agilex Biolabs, she is responsible for all aspects of assay development and the development team with a focus on PK, ADA, and biomarkers methods.

For the past 14 years, her work has been mainly focused on bioanalytical method development, specifically large molecules, including pharmacokinetic, biomarker, and immunogenicity assays. She has worked with a broad variety of molecules, including monoclonal antibodies, peptides, bispecific antibodies, recombinant and native proteins, and fusion proteins. Agata enjoys streaming the development process to make it the most resource and time-efficient. She holds a Master’s degree in Biotechnology.

Morgan Evans

Morgan Evans

Principal Method Development Scientist - IA, Agilex Biolabs

Following his studies in Biochemistry, Morgan has gained over 8 years of experience in the field of bioanalysis and biological characterization both in contract research organizations and academia. He has specialized knowledge in the development and validation of pharmacokinetic, biomarker, and immunogenicity assays. Having worked with a variety of technological platforms such as MesoScale Discovery, Gyrolab, ELISA, Biacore, Luminex, and cell-based assays he has the experience necessary to tailor an assay to the client’s drug development needs.

At Agilex Biolabs, Morgan is responsible for performing method developments and method transfers for ligand binding assays whilst adhering to regulations.

A keen trouble-shooter Morgan’s prime focus is always to deliver the most appropriate and highest quality assay to meet the client’s needs, with the ultimate goal of improving patients’ lives.

Emeline Larondeau

Emeline Larondeau

Senior Method Development Scientist - IA, Agilex Biolabs

Emeline has worked in the field of immunology for the past 8 years. After working on vaccine development, she gained expertise in pharmacokinetic, immunogenicity and biomarker assays. She has extensive experience in developing and validating immunoassays under GLP regulations that meet clients’ study requirements.

At Agilex Biolabs, she is responsible for developing immunoassays for the support of preclinical and clinical release studies. Emeline has a bachelor’s degree in Biology, Physics, and Chemistry and a master’s degree in Biotechnology.

A keen problem solver, Emeline is passionate about meeting bioanalytical challenges and delivering quality data.

Janki Patel
moderator

Janki Patel

Marketing Associate, Agilex Biolabs