Evidence map›Paper›PMID 41163552›Full record

ArticlemAbs2025

Monoclonal antibody formulations: a quantitative analysis of marketed products and patents.

Yixuan Peng, Liyang Lyu, Shiyun Chen, Baoming Ning, Chihua Li, Chuan-Yu Wu, Yuanjia Hu

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in mAbs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

7 authors.

Yixuan PengState Key Laboratory of Mechanism and Quality of Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao SAR, China.
Liyang LyuState Key Laboratory of Mechanism and Quality of Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao SAR, China.
Shiyun ChenState Key Laboratory of Mechanism and Quality of Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao SAR, China.
Baoming NingNational Institutes for Food and Drug Control, Beijing, China.
Chihua LiState Key Laboratory of Mechanism and Quality of Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao SAR, China.
Chuan-Yu WuSchool of Chemistry and Chemical Engineering, University of Surrey, Guildford, UK.
Yuanjia HuState Key Laboratory of Mechanism and Quality of Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao SAR, China.ORCID 0000-0001-5244-8577

Funding

Science and Technology Development Fund of Macau SAR 0049/2024/AGJScience and Technology Development Fund of Macau SAR 005/2023/SKLScience and Technology Development Fund of Macau SAR SKL-QRCM(UM)-2023-2025University of Macau MYRG-CRG2023-00007-ICMS-IASUniversity of Macau MYRG-GRG2024-00268-ICMS
6 · The paper itself

Abstract

Since the approval of OKT3® in 1986, monoclonal antibodies (mAbs) have become a cornerstone of modern therapeutics. However, their complex physicochemical properties pose challenges, particularly for high-concentration formulation and subcutaneous administration. Excipient selection is crucial for maintaining mAb stability and efficacy, yet existing studies often lack systematic, cross-source analyses. This study integrates data from marketed products and patents to investigate formulation trends and excipient preferences. Data were retrieved from the Drugs@FDA databases, CAS Formulations Database and Derwent Innovation as of December 31, 2024. Extracted information included target, indication, dosage form, route of administration, and formulation composition. The associations between formulation-related factors (e.g., antibody concentration, route of administration) and excipient selection were evaluated using proportion tests. A total of 6,119 patent records and 108 marketed mAb products (covering 388 patented and 141 marketed formulations) were analyzed. Proportion tests revealed significant associations between antibody concentration and the use of histidine (marketed

Indexed as

Antibodies, MonoclonalDrug CompoundingExcipientsChemistry, PharmaceuticalHumansPatents as TopicAntibodies, MonoclonalExcipientsconcentration-dependentexcipient selectionexcipient trendsmAb formulationsMonoclonal antibodypatentregulatory insightsubcutaneous delivery

Identifiers

PMID41163552
PMCPMC12578304

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.