Evidence map›Paper›PMID 41271848›Full record

ArticleScientific reports2025

Multi-attribute monitoring (MAM) methodology for glycosylated subunit vaccines.

Asif Shajahan, Lisa M Jenkins, Nathan Barefoot, Darielys Maldonado, Jeremy J Wolff, Yanhong Yang, Lisa A Kueltzo, Valerie Ficca, Elizabeth Scheideman, Ivan Loukinov and 8 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Scientific reports, 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. Article
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

18 authors.

Asif ShajahanVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA.
Lisa M JenkinsLaboratory of Cell Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Nathan BarefootVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA.
Darielys MaldonadoVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA.
Jeremy J WolffVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA.
Yanhong YangVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA.
Lisa A KueltzoVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA.
Valerie FiccaVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA.
Elizabeth ScheidemanVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA.
Ivan LoukinovVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA.
Carl CarruthersVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA.
Dorra BenmohamedVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA.
Daniel B GowetskiVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA.
Rong JiangVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA.
Sylvie R YangVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA.
Kevin CarltonVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA.
Jason G GallVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA.
Q Paula LeiVaccine Production Program Laboratory, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Gaithersburg, MD, USA. paula.lei@nih.gov.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Many protein-based vaccines comprise viral surface proteins which are chosen for their ability to stimulate the immune system. These vaccine molecules are often heavily glycosylated, and glycosylation plays critical roles in the immunological and stability properties of vaccines. The structural characterization and product quality attribute monitoring of such complex vaccine therapeutics during process development and manufacturing is very challenging. High throughput monitoring of multiple molecular attributes, particularly glycosylation, of recombinant glycoprotein subunit vaccines are needed to support entire vaccine production processes. Multi-attribute monitoring (MAM) technology involves assessing multiple critical molecular attributes of molecules in one set of analyses in an automated fashion, for product quality attribute requirements. MAM is still in the early development stages and is currently applied to therapeutics with very low levels of glycosylation such as monoclonal antibodies. MAM on glycoproteins with a higher number of glycosylation sites with high glycan heterogeneity such as subunit vaccine molecules is challenging as each glycan site and glycan modification exponentially increases data processing complexity. We developed a MAM workflow to perform detailed structural characterization of subunit protein vaccines, monitoring critical parameters such as intact mass, sequence identity, protein clipping, glycosylation, other post-translational modifications, and host cell proteins (HCP). By using a combination of software tools and product process monitoring strategy, we performed data processing at multiple steps and identified key attributes for each vaccine candidate under the development pipeline. Further, a high-throughput critical attribute monitoring MAM workflow was developed to support the influenza and HIV vaccine development processes including cell line selection, cell clone selection, cell culture optimization, stability study evaluation and final vaccine product characterization.

Indexed as

GlycoproteinsVaccines, SubunitGlycosylationHumansProtein Processing, Post-TranslationalSoftwareGlycoproteinsVaccines, Subunit

Identifiers

PMID41271848
PMCPMC12638818

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.