Evidence map›Paper›PMID 40827507›Full record

ReviewBioanalysis2025

Evolving bioanalytical strategies in the wake of pioneering biotherapeutics.

Federico Riccardi Sirtori, Andrea Di Ianni, Claudio Crosasso, Elisa Bertotti, Francesco Molinaro, Ilse De Salve, Luca Barbero, Kyra J Cowan

Abstract readReview
In one paragraph

Review in Bioanalysis, 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. Article
  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

8 authors.

Federico Riccardi SirtoriNBE-DMPK Innovative BioAnalytics, RBM S.p.A., an affiliate of Merck KGaA, Darmstadt, Germany.ORCID 0000-0003-0319-4966
Andrea Di IanniNBE-DMPK Innovative BioAnalytics, RBM S.p.A., an affiliate of Merck KGaA, Darmstadt, Germany.ORCID 0000-0002-3424-0585
Claudio CrosassoNBE-DMPK Innovative BioAnalytics, RBM S.p.A., an affiliate of Merck KGaA, Darmstadt, Germany.
Elisa BertottiNBE-DMPK Innovative BioAnalytics, RBM S.p.A., an affiliate of Merck KGaA, Darmstadt, Germany.
Francesco MolinaroNBE-DMPK Innovative BioAnalytics, RBM S.p.A., an affiliate of Merck KGaA, Darmstadt, Germany.
Ilse De SalveNBE-DMPK Innovative BioAnalytics, RBM S.p.A., an affiliate of Merck KGaA, Darmstadt, Germany.
Luca BarberoNBE-DMPK Innovative BioAnalytics, RBM S.p.A., an affiliate of Merck KGaA, Darmstadt, Germany.ORCID 0000-0003-1125-2599
Kyra J CowanNew Biological Entities,Drug Metabolism and Pharmacokinetics (NBE-DMPK), Research and Development, Merck KGaA, Darmstadt, Germany.ORCID 0000-0002-4811-7748

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The development of biotherapeutics, particularly multi-domain biotherapeutics (MDBs) and antibody drug conjugates (ADCs), presents unique challenges due to their complexity and increased immunogenicity risks. Bioanalytical approaches play a pivotal role in addressing these challenges. Robust bioanalytical methods are essential for effectively assessing the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenic responses of novel biologics. Advanced techniques, such as multiplexed assays using ligand binding assays (LBAs) and Liquid Chromatography-Mass Spectrometry (LC-MS) methods, are employed to handle the complexity of MDBs and ADCs effectively. Additionally, high-resolution mass spectrometry can investigate the potential biotransformation of biologics directly in in vivo studies. Furthermore, the Context of Use (CoU) is critical for defining assay purposes across nonclinical and clinical settings, ensuring their relevance and efficiency. Regulatory compliance is paramount to ensure assays meet standards for drug approval. Practical considerations include assay sensitivity, specificity, and the method's ability to investigate the structural integrity of MDBs and ADCs in

Indexed as

Biological ProductsAnimalsChromatography, LiquidHumansImmunoconjugatesMass SpectrometryBiological ProductsImmunoconjugatesADCBiotherapeuticsHRMSimmunoassayLBALC-MS

Identifiers

PMID40827507
PMCPMC12413061

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.