Urinary detection of insulin analogues : improvements in the Ghent laboratory
Bibliographic record
Abstract
Biosimilars of recombinant erythropoietin (rEPO) can present some small structural differences compared to the reference product.Three biosimilars, with apparent lighter molecular weight than the genuine rEPO (Eprex ), were selected for further investigation: Jimaixin™ authorized in China, and Hemax and Epotin™ authorized in Algeria.The aims of this research were: i) to study the electrophoretic EPO profiles obtained after a spike of the three biosimilars in urine and plasma by using improved IEF-PAGE and SDS-PAGE methods and to evaluate their identification using reevaluated criteria ii) to test complementary strategies to improve their detection: a two-dimensional electrophoresis approach (SDS separation following IEF) or a neuraminidase treatment of the sample (proposed to increase the separation between recombinant and endogenous EPO by SDS-PAGE), iii) to compare using MALDI-TOF the specific Nglycosylation pattern of each biosimilar with the original rEPO Eprex .Experiments with spiked samples indicated that the biosimilars were more difficult to detect at low doses than Eprex , in particular, Epotin™ and Jimaixin™ by IEF-PAGE in urine and Hemax by SDS-PAGE in plasma.IEF-PAGE for plasma samples and SDS-PAGE for urine samples had the highest identification rates considering the three biosimilars.Two-dimensional electrophoresis experiments did not improve the detection.Samples pre-treatment with neuraminidase gave more promising results for low doses as it slightly increased the detection.Compared to Eprex N-glycosylations, all three biosimilars presented a decrease in the most complex forms (loss of sugar antennae and sialic acids) while bi and tri antennae forms were enriched.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".