Evidence map›Paper›PMID 38459151›Full record

ArticleThe AAPS journal2024

Quality by Design Framework Applied to GMMA Purification.

Carlo Giannelli, Francesca Necchi, Elena Palmieri, Davide Oldrini, Beatrice Ricchetti, Maria M Papathanasiou, Zoltan Kis, Cleo Kontoravdi, Cristiana Campa, Francesca Micoli

Abstract read
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In one paragraph

Article in The AAPS journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

10 authors.

Carlo Giannelli *GSK Vaccines Institute for Global Health (GVGH), Via Fiorentina 1, 53100, Siena, Italy. carlo.x.giannelli@gsk.com.
Francesca Necchi *GSK Vaccines Institute for Global Health (GVGH), Via Fiorentina 1, 53100, Siena, Italy.
Elena PalmieriGSK Vaccines Institute for Global Health (GVGH), Via Fiorentina 1, 53100, Siena, Italy.
Davide OldriniGSK Vaccines Institute for Global Health (GVGH), Via Fiorentina 1, 53100, Siena, Italy.
Beatrice RicchettiGSK Vaccines Institute for Global Health (GVGH), Via Fiorentina 1, 53100, Siena, Italy.
Maria M PapathanasiouThe Sargent Centre for Process Systems Engineering, Department of Chemical Engineering, Imperial College London, South Kensington Campus, London, SW7 2AZ, UK.
Zoltan KisThe Sargent Centre for Process Systems Engineering, Department of Chemical Engineering, Imperial College London, South Kensington Campus, London, SW7 2AZ, UK.
Cleo KontoravdiThe Sargent Centre for Process Systems Engineering, Department of Chemical Engineering, Imperial College London, South Kensington Campus, London, SW7 2AZ, UK.
Cristiana CampaGSK, Via Fiorentina 1, 53100, Siena, Italy.
Francesca MicoliGSK Vaccines Institute for Global Health (GVGH), Via Fiorentina 1, 53100, Siena, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In recent years, Generalized Modules for Membrane Antigens (GMMA) have received increased attention as an innovative vaccine platform against bacterial pathogens, particularly attractive for low- and middle-income countries because of manufacturing simplicity. The assessment of critical quality attributes (CQAs), product-process interactions, identification of appropriate in process analytical methods, and process modeling is part of a robust quality by design (QbD) framework to support further development and control of manufacturing processes. QbD implementation in the context of the GMMA platform will ensure robust manufacturing of batches with desired characteristics, facilitating technical transfer to local manufacturers, regulatory approval, and commercialization of vaccines based on this technology. Here, we summarize the methodology suggested, applied to a first step of GMMA manufacturing process.

Indexed as

Vaccine DevelopmentVaccinesVaccinesGeneralized Modules for Membrane Antigens (GMMA)manufacturingquality by designultrafiltration

Identifiers

PMID38459151

What OpenQuestion holds

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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.