Evidence map›Paper›PMID 37175746›Full record

ArticleInternational journal of molecular sciences2023

Biological Assay to Determine Gonadotropin Potency: From In Vivo to In Vitro Sustainable Method.

Francesco Nevelli, Angelo Palmese, Ralf Gleixner, Flavio Peroglio, Cosimo-Walter D'Acunto, Aurora Dadone, Thomas D'Hooghe, Monica Lispi

Abstract read
In one paragraph

Article in International journal of molecular sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. An AlternativeACS omega · 2025
    Article
  4. Review
  5. Article
  6. 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

8 authors.

Francesco NevelliAnalytical Development Biotech-Global Analytical Development-Global Development & Launch-Global Healthcare Operation, Istituto di Ricerche Biomediche "Antoine Marxer" RBM S.p.A., Colleretto Giacosa, Via Ribes, 1, 10010 Samone, Italy.
Angelo PalmeseAnalytical Development Biotech-Global Analytical Development-Global Development & Launch-Global Healthcare Operation, Merck Serono S.p.A., Piazza del Pigneto, 9, 00176 Rome, Italy.
Ralf GleixnerAres Trading S.A., Rue de l'Ouriette 151, 1170 Aubonne, Switzerland.
Flavio PeroglioGHO Ivrea QC & Scientific Excellence-Global Analytical Development-Global Development & Launch-Global Healthcare Operation, Istituto di Ricerche Biomediche "Antoine Marxer" RBM S.p.A., Colleretto Giacosa, Via Ribes, 1, 10010 Samone, Italy.
Cosimo-Walter D'AcuntoAnalytical Development Biotech-Global Analytical Development-Global Development & Launch-Global Healthcare Operation, Istituto di Ricerche Biomediche "Antoine Marxer" RBM S.p.A., Colleretto Giacosa, Via Ribes, 1, 10010 Samone, Italy.
Aurora DadoneAnalytical Development Biotech-Global Analytical Development-Global Development & Launch-Global Healthcare Operation, Istituto di Ricerche Biomediche "Antoine Marxer" RBM S.p.A., Colleretto Giacosa, Via Ribes, 1, 10010 Samone, Italy.
Thomas D'HoogheGlobal Medical Affairs Fertility, Merck Healthcare KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany.
Monica LispiGlobal Medical Affairs Fertility, Merck Healthcare KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany.ORCID 0000-0002-9920-3208

Funding

Merck (Germany) N/A
6 · The paper itself

Abstract

Various preparations of follicle-stimulating hormone (FSH) are commercially available; however, they differ in glycoforms composition and purity owing to their respective sources. Additional chemical/physical changes can also be introduced during manufacturing and can impact their biological activity (biopotency), which is routinely assessed using an in vivo bioassay (Steelman-Pohley). This study aimed to determine whether an in vitro bioassay could assess biopotency by distinguishing between r-hFSH chemical/physical variants with similar ability to the in vivo bioassay. The specific activity (units of biological activity per mg of product) of variants of r-hFSH generated through enrichment (acidic/basic), stress (oxidative/acidic pH) and enzymatic treatment (desialylation and desialylation/degalactosylation) was compared using the in vivo and in vitro bioassays. The in vitro bioassay reliably detected potential chemical/physical modifications in r-hFSH variants that may impact biopotency. Overall, the methods demonstrated a comparable ability to detect changes in specific activities due to chemical/physical differences in r-hFSH variants. These data indicate that the in vitro bioassay is suitable to replace the in vivo bioassay.

Indexed as

Follicle Stimulating HormoneFollicle Stimulating Hormone, HumanBiological AssayIn Vitro TechniquesFollicle Stimulating HormoneFollicle Stimulating Hormone, Humanbioassayforced degradationin vitroin vivopotencyr-hFSHspecific activity

Identifiers

PMID37175746
PMCPMC10178553

What OpenQuestion holds

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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.