Evidence map›Paper›PMID 37110538›Full record

ArticleMolecules (Basel, Switzerland)2023

Innovative Metrics for Reporting and Comparing the Glycan Structural Profile in Biotherapeutics.

Renato Mastrangeli, Abhijeet Satwekar, Horst Bierau

Abstract read
In one paragraph

Article in Molecules (Basel, Switzerland), 2023. 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. Article
  2. Article
  3. Article
  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

3 authors.

Renato MastrangeliGlobal CMC Development Technology & Innovation, CMC Science & Intelligence, Merck Serono SpA (An affiliate of Merck KGaA, Darmstadt, Germany), Guidonia Montecelio, 00012 Rome, Italy.
Abhijeet SatwekarGlobal CMC Development, Global Analytical Development, Global Analytical-Pharmaceutical Science & Innovation, Merck Serono SpA (An affiliate of Merck KGaA, Darmstadt, Germany), Guidonia Montecelio, 00012 Rome, Italy.ORCID 0000-0002-2355-9849
Horst BierauGlobal CMC Development Technology & Innovation, CMC Science & Intelligence, Merck Serono SpA (An affiliate of Merck KGaA, Darmstadt, Germany), Guidonia Montecelio, 00012 Rome, Italy.ORCID 0000-0001-8719-6138

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Glycosylation is a critical quality attribute in biotherapeutics, impacting properties such as protein stability, solubility, clearance rate, efficacy, immunogenicity, and safety. Due to the heterogenic and complex nature of protein glycosylation, comprehensive characterization is demanding. Moreover, the lack of standardized metrics for evaluating and comparing glycosylation profiles hinders comparability studies and the establishment of manufacturing control strategies. To address both challenges, we propose a standardized approach based on novel metrics for a comprehensive glycosylation fingerprint which greatly facilitates the reporting and objective comparison of glycosylation profiles. The analytical workflow is based on a liquid chromatography-mass spectrometry-based multi-attribute method. Based on the analytical data, a matrix of glycosylation-related quality attributes, both at site-specific and whole molecule level, are computed, which provide metrics for a comprehensive product glycosylation fingerprint. Two case studies illustrate the applicability of the proposed indices as a standardized and versatile approach for reporting all dimensions of the glycosylation profile. The proposed approach further facilitates the assessments of risks associated with changes in the glycosylation profile that may affect efficacy, clearance, and immunogenicity.

Indexed as

PolysaccharidesChromatography, LiquidGlycosylationKineticsPolysaccharidesbiosimilaritybiotherapeuticscharacterizationglycan analysisglycopeptide mappingglyco-similarityglycosylation indexN-glycosylationstandardization comparability

Identifiers

PMID37110538
PMCPMC10143042

What OpenQuestion holds

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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.