In 2019 two key documents were published that redefined the landscape for biomarker analysis using ligand binding assays. The ICH-M10 (EMA) and C-Path Institute guidance advised on validation principles for scientists working with biological samples. With this guidance in mind, we started a program to implement changes to ELISAs that would allow researchers to address key concerns such as endogenous sample detection and assay validation and apply long-term lot-to-lot consistency, should it fit their context of use.
This project required:
- Creation of new physiochemically-evaluated critical reagents
- Expansion of existing feasibility testing
- Enhancement of QC criteria (e.g., sample library lot bridging)
This webinar will:
- Detail each of these steps with data from our Conferma® ELISA development and QC processes
- Describe its impact on their performance
- Discuss if this could become a broadly accepted practice
Speakers
Lawrence Rentoul
Merck
Portfolio Lead, ELISAs & Specialty Assays
Lawrence Rentoul is the Portfolio Lead for ELISAs and Specialty Assays. He joined the company in 2008 and has spent the majority of the time working in the field of biomarker analysis, either directly with researchers or strategically within the business. In 2017, he moved from Edinburgh in the United Kingdom to St. Louis, Missouri, USA to be based with his R&D, Quality, and Manufacturing colleagues, and joined the Product Management team.
Protein biology
- ELISA
Duration:1h 3min
Language:English
Session 1:presented January 26, 2023
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