NDLI: Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development

Content Provider	Springer Nature Link
Author	Jani, Darshana Allinson, John Berisha, Flora Cowan, Kyra J. Devanarayan, Viswanath Gleason, Carol Jeromin, Andreas Keller, Steve Khan, Masood U. watzke, Bill Rhyne, Paul Stephen, Laurie
Copyright Year	2015
Abstract	Multiplex ligand binding assays (LBAs) are increasingly being used to support many stages of drug development. The complexity of multiplex assays creates many unique challenges in comparison to single-plexed assays leading to various adjustments for validation and potentially during sample analysis to accommodate all of the analytes being measured. This often requires a compromise in decision making with respect to choosing final assay conditions and acceptance criteria of some key assay parameters, depending on the intended use of the assay. The critical parameters that are impacted due to the added challenges associated with multiplexing include the minimum required dilution (MRD), quality control samples that span the range of all analytes being measured, quantitative ranges which can be compromised for certain targets, achieving parallelism for all analytes of interest, cross-talk across assays, freeze-thaw stability across analytes, among many others. Thus, these challenges also increase the complexity of validating the performance of the assay for its intended use. This paper describes the challenges encountered with multiplex LBAs, discusses the underlying causes, and provides solutions to help overcome these challenges. Finally, we provide recommendations on how to perform a fit-for-purpose-based validation, emphasizing issues that are unique to multiplex kit assays.
Starting Page	1
Ending Page	14
Page Count	14
File Format	PDF
ISSN	12341234
Journal	The AAPS Journal
Volume Number	18
Issue Number	1
e-ISSN	15507416
Language	English
Publisher	Springer US
Publisher Date	2015-09-16
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	New York
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Pharmacology/Toxicology Biochemistry Biotechnology Pharmacy
Content Type	Text
Resource Type	Article

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