Evidence map›Paper›PMID 40968313›Full record

ArticleThe AAPS journal2025

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

Jason Pennucci, Amanda Hays, Wendy Adamowicz, Mitra Azadeh, Mohamed Benhammadi, Enric Bertran Portabella, MingLai Cheng, Kelly Colletti, Sanjay L Dholakiya, Rajitha Doddareddy and 32 more

Abstract read
PubMed Publisher
In one paragraph

Article in The AAPS journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

42 authors.

Jason PennucciModerna, Inc, Cambridge, Massachusetts, USA.
Amanda HaysBioAgilytix Laboratories, Durham, North Carolina, USA. amanda.hays@bioagilytix.com.ORCID 0000-0002-3429-4727
Wendy AdamowiczPPD Clinical Research, Thermo Fisher Scientific, Richmond, Virginia, USA.
Mitra AzadehUltragenyx Pharmaceutical, Inc, Novato, California, USA.
Mohamed BenhammadiCharles River Labs, Senneville, Quebec, Canada.
Enric Bertran PortabellaModerna Inc, Harwell, Oxford, UK.
MingLai ChengQPS, LLC, Newark, Delaware, USA.
Kelly CollettiBeam Therapeutics Inc, Cambridge, Massachusetts, USA.
Sanjay L DholakiyaBristol Myers Squibb, Lawrenceville, New Jersey, USA.
Rajitha DoddareddyMerck & Co., Inc, Rahway, New Jersey, USA.
Lara DuchsteinBioAgilytix Laboratories, Hamburg, Germany.
Jennifer DurhamBioAgilytix Laboratories, Boston, Massachusetts, USA.
Sebastian GuelmanGenentech, Inc, South San Francisco, California, USA.
Bryan GullickBioAgilytix Laboratories, Durham, North Carolina, USA.
Kate HerrJohnson & Johnson, Spring House, Pennsylvania, USA.
Darshana JaniModerna, Inc, Cambridge, Massachusetts, USA.
Niketa JaniNovartis Biomedical Research, Cambridge, Massachusetts, USA.
Oskar JohanssonTATAA Biocenter, Gothenburg, Sweden.
Kaarthik JohnUnaffiliated, Bangalore, India.
Mikael KubistaInstitute of Biotechnology, Czech Academy of Sciences, Prague, Czechia.
Amy LavellePPD Clinical Research, Thermo Fisher Scientific, Richmond, Virginia, USA.
Geng LiLabcorp, Harrogate, UK.
Yanchun LiJohnson & Johnson, Spring House, Pennsylvania, USA.
Hsing-Yin LiuJohnson & Johnson, Spring House, Pennsylvania, USA.
Timothy LochmannPPD Clinical Research, Thermo Fisher Scientific, Richmond, Virginia, USA.
Haiyan MaNorthern Biomolecular Services, Portage, Michigan, USA.
Benjamin MoritzCharles River Laboratories, Reno, Nevada, USA.
Jacqueline MurphyJohnson & Johnson, Spring House, Pennsylvania, USA.
Alice ParkBristol Myers Squibb, Lawrenceville, New Jersey, USA.
Suresh PeddigariModerna, Inc, Cambridge, Massachusetts, USA.
Marie-Soleil PicheCharles River Labs, Senneville, Quebec, Canada.
Swarna Suba RamaswamyEli Lilly and Company, Indianapolis, Indiana, USA.
Asha ReddyModerna, Inc, Cambridge, Massachusetts, USA.
Muriel SmetSanofi, Ghent, Belgium.
Johannes StantaCelerion Inc, Lincoln, NE, USA.ORCID 0000-0001-6015-515X
Jenny ValentineRegeneron Pharmaceuticals Inc, Tarrytown, New York, USA.
Katherine VeirsQPS, LLC, Newark, Delaware, USA.
Venkata VepacheduPennsylvania Department of Health, Exton, Pennsylvania, USA.
Mark WisselEurofins Viracor Biopharma Services, LLC, Lenexa, Kansas, USA.
Meizhen WuJohnson & Johnson, Spring House, Pennsylvania, USA.
Bin XuABX Biotech LLC, Ambler, Pennsylvania, USA.
Susan ZondloQPS, LLC, Newark, Delaware, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

LipidsNanoparticlesReal-Time Polymerase Chain ReactionReverse Transcriptase Polymerase Chain ReactionRNA, MessengerAnimalsHumansLiposomesLipid NanoparticlesLipidsLiposomesRNA, MessengerLNPMRNAPKRT-dPCRRT-qPCR

Identifiers

PMID40968313

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.