Evidence map›Paper›PMID 41599285›Full record

ArticleMolecules (Basel, Switzerland)2026

Quantitative and Comparative Assessment of Recombinant Human β-Glucocerebrosidase Uptake Bioactivity Using a Stable hMMR-Expressing CHO Cell Model.

Lyuyin Wang, Kaixin Xu, Ping Lyu, Xinyue Hu, Jing Li

Abstract readComparative Study
In one paragraph

Article in Molecules (Basel, Switzerland), 2026. 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. 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

5 authors.

Lyuyin WangNational Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, No. 31, Huatuo Road, DaXing District, Beijing 102629, China.
Kaixin XuSchool of Life Science and Technology, China Pharmaceutical University, No. 639, Longmian Road, JiangNing District, Nanjing 210009, China.
Ping LyuNational Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, No. 31, Huatuo Road, DaXing District, Beijing 102629, China.
Xinyue HuNational Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, No. 31, Huatuo Road, DaXing District, Beijing 102629, China.
Jing LiNational Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, No. 31, Huatuo Road, DaXing District, Beijing 102629, China.

Funding

State Key Laboratory of Drug Regulatory Science 2024SKLDRS0203
6 · The paper itself

Abstract

Inconsistent conclusions on the cellular uptake of recombinant human β-glucocerebrosidase (rhGCase) for Gaucher disease stem from a fundamental limitation of existing methods: their inability to generate complete and reliable dose-response curves. This critical flaw, stemming from susceptibility to various experimental variables, prevents accurate potency comparison across different rhGCase products. To address this, we developed a robust bioassay using CHO-K1 cells stably expressing the human macrophage mannose receptor (hMMR). Our method quantifies uptake by measuring the enzymatic activity of internalized rhGCase and consistently produces a classic sigmoidal dose-response curve. Comprehensive validation and mechanistic studies, including inhibition experiments with mannose, fucose, and mannose-6-phosphate, confirmed that uptake is specifically mediated by hMMR, with successful enzyme transport to endosomes/lysosomes. Applying this assay to three commercial products yielded results contrary to prior literature: imiglucerase demonstrated superior uptake activity to velaglucerase alfa. The proposed method represents a significant improvement over existing assays, providing a more accurate and reproducible means to evaluate cellular uptake bioactivity, which is crucial for the quality control of rhGCase therapeutics.

Indexed as

GlucosylceramidaseLectins, C-TypeReceptors, Cell SurfaceRecombinant ProteinsAnimalsCHO CellsCricetinaeCricetulusGaucher DiseaseHumansLysosomesMannose ReceptorGlucosylceramidaseimigluceraseLectins, C-TypeMannose ReceptorReceptors, Cell SurfaceRecombinant ProteinsVelaglucerase alfa, humancellular uptake bioactivitygaucher diseasemethod validationquality controlreceptor-mediated endocytosisβ-glucocerebrosidase

Identifiers

PMID41599285
PMCPMC12844381

What OpenQuestion holds

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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.