Technical Considerations of Pharmacokinetic Assays for LNP-mRNA Drug Products by RT-qPCR

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F86652036%3A_____%2F25%3A00639450" target="_blank" >RIV/86652036:_____/25:00639450 - isvavai.cz</a>

Výsledek na webu

<a href="https://link.springer.com/article/10.1208/s12248-025-01122-w" target="_blank" >https://link.springer.com/article/10.1208/s12248-025-01122-w</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1208/s12248-025-01122-w" target="_blank" >10.1208/s12248-025-01122-w</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Technical Considerations of Pharmacokinetic Assays for LNP-mRNA Drug Products by RT-qPCR

Popis výsledku v původním jazyce

Lipid nanoparticle-messenger RNA (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 (PK) 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 paper is to provide information on considerations for validation of regulated reverse transcription quantitative PCR (RT-qPCR) assays that are used to support the pharmacokinetic analysis of LNP-mRNA drug products.

Název v anglickém jazyce

Technical Considerations of Pharmacokinetic Assays for LNP-mRNA Drug Products by RT-qPCR

Popis výsledku anglicky

Lipid nanoparticle-messenger RNA (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 (PK) 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 paper is to provide information on considerations for validation of regulated reverse transcription quantitative PCR (RT-qPCR) assays that are used to support the pharmacokinetic analysis of LNP-mRNA drug products.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30104 - Pharmacology and pharmacy

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

AAPS Journal

ISSN

1550-7416

e-ISSN

1550-7416

Svazek periodika

27

Číslo periodika v rámci svazku

6

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

18

Strana od-do

144

Kód UT WoS článku

001575270000001

EID výsledku v databázi Scopus

2-s2.0-10501676485