INSIDER SESSION
Technical Considerations of RT-qPCR Pharmacokinetic Assays for LNP‑mRNA Drug Products
Now Streaming On-Demand
LNP-mRNA drug products are a growing class of drug modalities. The unique composition of these drug products requires multiple measurements to account for the different components of these drug modalities. Pharmacokinetic measurements include measurement of the encapsulated mRNA and components of the LNP in circulation to understand the effectiveness of the therapeutic mRNA. The PK measurements can utilize many different platforms including PCR.
Current regulatory guidance documents for bioanalytical method validation are specific to ligand binding and chromatographic assay methods and difficult to interpret for use with molecular workflows.
The purpose of this webinar is to provide information from panelists who authored a white paper on technical considerations for validation of regulated RT-qPCR assays that are used to support the pharmacokinetic analysis of LNP-mRNA drug products.
Key Takeaways
- Differences in the RT-qPCR workflow for PK as compared to other more common PK bioanalytical platforms
- Technical considerations when developing RT-qPCR PK assays for measuring LNP mRNA drug products
- Validation parameters and appropriate acceptance criteria for these regulated assays
Our experts will discuss lessons learned from their experiences and offer insight into the multiple stages of specific assays including critical reagents, regulatory standards, assay formats and timelines.
- Amanda Hays, Scientific Officer, BioAgilytix
- Bryan Gullick, Scientific Operations, BioAgilytix
- Jason Pennucci, Director Bioanalytical Sciences, Moderna
- Suresh Peddigari, Scientist, Moderna
- Mark Wissel, Director, Eurofins Biopharma Services
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