On this episode of Molecular Moments, Dr. Jim McNally chats with DMPK Senior Director Dr. David Johnson, Ph.D., from BioAgilytix
Reagent Lifecycle Management for Robust, Reproducible Assay Performance
BioAgilytix has comprehensive knowledge around critical reagent management processes to support your assay needs throughout the lifecycle of drug development – from discovery and development to post-marketing surveillance. Our approach minimizes assay performance problems caused by declining reagent activity, and can mitigate the risk of delays during preclinical and clinical studies.
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Critical reagents are those essential components of ligand-binding assays (LBAs) whose unique characteristics are crucial to assay performance and therefore require thorough characterization and documentation. Unlike other analytical technologies, these assays require specific biomolecular interactions between the critical reagents and the analyte.
Critical reagents can include binding reagents such as binding proteins, antibodies and conjugated antibodies, as well as positive and negative control. Because they are typically produced via biological processes, they are inherently prone to variability from lot to lot. Even slight production changes could significantly impact ligand binding assay performance, so a well-defined critical reagent management strategy is needed to ensure reagents are characterized, and that their structural integrity and stability are appropriately upheld through the stages of development.
This white paper discusses the considerations for the generation, production, characterization, qualification, documentation, and management of critical reagents in LBAs.
BioAgilytix seamlessly translates specialized large molecule expertise into a proven strategy for generating and maintaining high-quality critical reagents. Our expertise includes reagent qualification, commercial kit bridging, initial reagent generation, and resupply cycles. We also perform reagent generation and labeling for protein and antibodies, biotin, ruthenium, lanthanides, and fluorescein.We offer critical reagent lifecycle management services in support of both non-regulated and regulated studies, and depending on your project or your need, we can provide either a Record of Analysis (RoA) or Certificate of Analysis (CoA). Through proactive reagent management, we ensure the quality of critical reagents is appropriate and consistent for their intended use throughout all stages of the drug development process.
BioAgilytix understands and performs key risk management activities for each stage of the critical reagent lifecycle.
Download this helpful resource to discover the 8 key selection criteria you should consider when evaluating a bioanalytical CRO to ensure a successful partnership.
The inherent variability in critical reagents makes a clearly defined management system crucial – whether they are prepared in-house, outsourced, utilized individually, or as part of a commercial kit. Trust the experts in large molecule bioanalysis to accurately generate, qualify, characterize, and manage the critical reagents you need to ensure consistent, robust assay performance.
The parameters we establish around the characterization, maintenance, long-term storage, and inventorying of your critical reagents will help us successfully support the bioanalytical demands of your drug development project, from assay development and validation to timely sample analysis and data collection – as well as seamless transition of assays between laboratories as needed. Innovate faster and more effectively with BioAgilytix as your trusted bioanalytical lab partner.