Description
Traditionally, bioanalysis of biotherapeutics has been conducted using ligand binding assays. While these assays are considered the gold standard in bioanalysis of proteins and large molecules, they require high quality reagents and the quality of data is directly dependent on these reagents. In the last few years, LC-MS has emerged as an alternative approach for the bioanalysis of biotherapeutics and is becoming more mature in the regulated environment. While the FDA Bioanalytical Method Validation guidance (May 2018) clearly delineates the requirements for method validation using chromatographic and ligand binding assays for small molecules and large molecules, respectively, there is a lack of clarity for LC-MS analysis of biotherapeutics. In the last few months, a need for further clarification of the regulatory requirements for these assays have been raised by the industry. It is now time to have a Crystal City Type meeting that will engage a dialogue between the industry experts in this field and the regulators to clarify the regulatory requirements for the validation of these assays in support of subsequent successful filings.
After attending the Arden House Conference, the participants will:
- The participants will share their validation and sample analysis experience, engage in the discussion, and contribute to the understanding of the issues that are fundamental to assay performance.
- The participants further discuss how different workflows may impact the acceptance criteria for these types of assays.
- The participants will work together to develop a consensus document for the method validation and bioanalysis of biotherapeutics by LC-MS/MS, including hybrid immunoaffinity LC-MS/MS.
Conference Chairs
Faye Vazvaei-Smith, M.S., Merck (Co-Chair)
Brian P. Booth, Ph.D., U.S. Food and Drug Administration (Co-Chair)
Scientific Planning Committee
Surinder Kaur, Genentech
John Kadavil, U.S. Food and Drug Administration
Wenkui Li, Ph.D., Novartis
Mark Arnold, Ph.D., FAAPS, Covance Inc.
Eric Woolf, Merck and Co
Eric N. Fluhler, Ph.D., Bioanalytical Compliance Associates, LLC