Evidence map›Paper›PMID 40790361›Full record

ReviewAnalytical and bioanalytical chemistry2026

Biopharmaceutical analysis - current analytical challenges, limitations, and perspectives.

Diana R Cunha, M Beatriz Quinaz, Marcela A Segundo

Abstract readReview
In one paragraph

Review in Analytical and bioanalytical chemistry, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

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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.

Diana R CunhaLAQV, REQUIMTE, Laboratory of Applied Chemistry, Department of Chemical Sciences, Faculty of Pharmacy, University of Porto, 4050-213, Porto, Portugal. dianarlcunha@gmail.com.ORCID http://orcid.org/0000-0002-2082-2568
M Beatriz QuinazLAQV, REQUIMTE, Laboratory of Applied Chemistry, Department of Chemical Sciences, Faculty of Pharmacy, University of Porto, 4050-213, Porto, Portugal.ORCID http://orcid.org/0000-0003-1977-3006
Marcela A SegundoLAQV, REQUIMTE, Laboratory of Applied Chemistry, Department of Chemical Sciences, Faculty of Pharmacy, University of Porto, 4050-213, Porto, Portugal. msegundo@ff.up.pt.ORCID http://orcid.org/0000-0003-2938-0214

Funding

Fundação para a Ciência e a Tecnologia 2020.04917.BDFundação para a Ciência e a Tecnologia UID/50006
6 · The paper itself

Abstract

Biopharmaceutical analysis is essential for ensuring the quality, safety, and efficacy of these medicines. Nonetheless, it faces significant challenges due to the complexity of these molecules and the strict regulatory standards. This work explores the strengths, limitations, opportunities, and threats in biopharmaceutical analysis, focusing on the challenges and emerging analytical technologies and their impact on biopharmaceutical development and quality control. Key challenges identified include the complexity and heterogeneity of biopharmaceuticals leading to the requirement for a broad spectrum of analytical methods, the high cost of the required analytical instrumentation, and the need for skilled professionals to implement advanced analytical techniques. Integrating artificial intelligence-driven data analysis, automation, and multi-omics approaches can significantly improve analytical precision and efficiency. However, regulatory barriers and financial constraints remain critical obstacles to widespread adoption. This work highlights the need for industry-wide collaboration to standardize methodologies and regulations, improve data integrity, and facilitate regulatory acceptance by reviewing the last 5 years of biopharmaceutical-related works. Ultimately, the continued development of biopharmaceutical analysis, driven by technological advancements and strategic investments, is crucial for biopharmaceutical development, enhancing manufacturing efficiency, and ensuring broader access to high-quality biopharmaceuticals.

Indexed as

Biological ProductsBiopharmaceuticsArtificial IntelligenceHumansQuality ControlBiological ProductsBiologicsBiopharmaceutical analysisBiosimilarsQuality controlRegulatory harmonization

Identifiers

PMID40790361
PMCPMC12783247

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.