Evidence map›Paper›PMID 38814403›Full record

ArticleMethods in molecular biology (Clifton, N.J.)2024

Quality by Digital Design for Developing Platform RNA Vaccine and Therapeutic Manufacturing Processes.

Adithya Nair, Kate A Loveday, Charlotte Kenyon, Jixin Qu, Zoltán Kis

Abstract read
PubMed Publisher
In one paragraph

Article in Methods in molecular biology (Clifton, N.J.), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. IntegratedMolecular therapy. Nucleic acids · 2026
    Article
  2. Review
  3. Quality by design in public healthcare: a rapid development framework for future pandemics.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2026
    Review
  4. 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

5 authors.

Adithya NairDepartment of Biological and Chemical Engineering, University of Sheffield, Sheffield, UK.
Kate A LovedayDepartment of Biological and Chemical Engineering, University of Sheffield, Sheffield, UK.
Charlotte KenyonDepartment of Biological and Chemical Engineering, University of Sheffield, Sheffield, UK.
Jixin QuDepartment of Biological and Chemical Engineering, University of Sheffield, Sheffield, UK.
Zoltán KisDepartment of Biological and Chemical Engineering, University of Sheffield, Sheffield, UK. z.kis@sheffield.ac.uk.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Quality by digital design (QbDD) utilizes data-driven, mechanistic, or hybrid models to define and optimize a manufacturing design space. It improves upon the QbD approach used extensively in the pharmaceutical industry. The computational models developed in this approach identify and quantify the relationship between the product's critical quality attributes (CQAs) and the critical process parameters (CPPs) of unit operations within the manufacturing process. This chapter discusses the QbDD approach in developing and optimizing unit operations such as in vitro transcription, tangential flow filtration, affinity chromatography, and lipid nanoparticle (LNP) formulation in mRNA vaccine manufacturing. QbDD can be an efficient framework for developing a production process for a disease-agnostic product that requires extensive experimental and model-based process-product interaction characterization during the early process development phase.

Indexed as

Quality ControlChromatography, AffinityHumansLipidsLiposomesmRNA VaccinesNanoparticlesLipid NanoparticlesLipidsLiposomesmRNA VaccinesAffinity chromatographyDigital twinsIn vitro transcriptionLipid nanoparticlemRNA vaccinesQuality by digital designTangential flow filtration

Identifiers

PMID38814403

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.