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Overcoming Disease Specific Matrix Effects in a Clinical Pharmacokinetic Assay






December 6, 2017
11 am to 12 pm EST

 

Sponsored by
Gyros Protein Technologies

 

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Webinar Description:

With the increase in biotherapeutics being assessed in multiple indications, it is critical to ensure that the methods and strategies used for bioanalysis are appropriate across all evaluated matrices and indications. In many instances enzyme-linked immunosorbent assay (ELISA) is still the method of choice to support pharmacokinetic (PK) evaluation of biotherapeutics. However, development of an ELISA that can tolerate biological matrix in multiple indications can be challenging, requiring further optimization of the assay in each indication. This may require multiple validated versions of an ELISA method which can impose additional resource needs, costs, and logistical challenges.

Etrolizumab is a humanized monoclonal antibody (mAb) with novel gut mucosal-selective lymphocyte anti-trafficking activity and has demonstrated to be capable of inducing clinical remission in ulcerative colitis (UC) patients in a Phase II clinical study. In the Phase III program currently underway, a second form of inflammatory bowel disease (Crohn’s Disease, or CD) is being studied, in addition to UC. Although the original PK ELISA assay was successfully validated in both normal human and UC sera and used for the phase I and phase II studies, attempts to matrix extend the ELISA for use in the CD population failed. This prompted additional work including optimization of the original ELISA and even re-development of the assay using different antibody pairs. Unfortunately, no substantive improvements were achieved, necessitating assay re-development using an alternative technology.

This webinar highlights the challenges we encountered with optimization/re-development of the original ELISA to overcome matrix interference in the CD population, and the qualification results of the new assay on the Gyros platform.

Learning Objectives:

  • Development of an ELISA that can tolerate biological matrix in multiple indications can be challenging, requiring further optimization of the assay in each indication
  • Challenges encountered with optimization/re-development of the original ELISA to overcome matrix interference in the disease population
  • Qualification results of the new assay on the Gyros platform

Speaker:

Kathi J. Williams

Senior Scientific Researcher
Assay Development and Technology

Genentech, Inc.

After completing a degree in Chemistry from Duke University, Kathi has worked in the bioanalytical chemistry industry for over 30 years with such companies as Beckman Coulter, Caliper Life Sciences, Applied Biosystems, Pall FortéBio, Gyros and Genentech in both research and assay development roles. She has specialized in microfluidics, separation science and biomolecular interactions for both DNA and protein analyses, with several publications on these subjects.

Kathi joined Genentech in 2014 as an Senior Scientific Researcher in the Assay Development and Technology group. In this short period, she has worked on a number of assay improvements using the Gyrolab for several drugs in clinic.



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