General practices for critical reagent usage in bioanalytical laboratories
Critical reagents for ligand binding assays (LBA) are essential components for bioanalytical testing. These include, but are not limited to: antibodies used as positive control, capture, or detection reagents; peptides as drug targets; reference standards as test analytes for pharmacokinetics; positive controls for immunogenicity studies and matrices.
Critical reagents are crucial for assay performance and data comparability across different laboratories and countries since they directly impact the results of an assay. Thus, they need to be well characterized and validated for proper execution of preclinical and clinical studies. Critical reagent stocks must also be maintained and their sources recorded.
Proper lifecycle management, validation documentation and qualification of lot-to-lot bridging evaluation will ensure consistency in assay performance, in addition to complying with regulatory requirements. The following presentation discusses the general practices for critical reagent usage in bioanalytical labs.
To follow up this webinar event, we have answers to some of the questions submitted during the live Q&A session. To learn more, visit this feature page to read Santosh’s answers.
What will you learn?
- General industry standards for utilizing critical reagents in bioanalytical labs
- The importance of bridging various lots of critical reagents and maintaining stocks
- Review proper storage, management and documentation of critical reagents
Who may this interest?
- Scientists and Principal investigators working in regulated environments
- Procurement, reagent management and quality assurance teams
- Reagent preparation teams. Reagent manufacturing vendors
Speaker
Santosh Shah, PhD
Associate Director, SME
Biologics at Frontage Laboratories (PA, USA)
Dr Santosh Shah is an Associate Director, Subject Matter Expert for the Biologics team at Frontage Laboratories (PA, USA), providing scientific leadership contributing to the development of the Global Biologics Strategy. Santosh works as a liaison between business operations, development, and various other departments. He has also been involved with communicating and presenting bioassay capabilities to biopharma sponsors. He also leads the automation development team at Frontage.
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