Evidence map›Paper›PMID 35292912›Full record

ArticlePharmaceutical research2022

A Reference Standard for Analytical Testing of Erythropoietin.

Huiping Tu, Kevin Carrick, Rebecca Potts, Mark Hasselberg, Mark Verdecia, Chris Burns, Ben Cowper, Fouad Atouf

Abstract read
In one paragraph

Article in Pharmaceutical research, 2022. 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

8 authors.

Huiping TuUnited States Pharmacopeial Convention, 12601 Twinbrook Pkwy, Rockville, Maryland, 20852, USA.
Kevin CarrickUnited States Pharmacopeial Convention, 12601 Twinbrook Pkwy, Rockville, Maryland, 20852, USA.
Rebecca PottsUnited States Pharmacopeial Convention, 12601 Twinbrook Pkwy, Rockville, Maryland, 20852, USA.
Mark HasselbergUnited States Pharmacopeial Convention, 12601 Twinbrook Pkwy, Rockville, Maryland, 20852, USA.
Mark VerdeciaUnited States Pharmacopeial Convention, 12601 Twinbrook Pkwy, Rockville, Maryland, 20852, USA.
Chris BurnsNational Institute for Biological Standards and Control, Blanche Lane, South Mimms, Hertfordshire, EN6 3QG, UK.
Ben CowperNational Institute for Biological Standards and Control, Blanche Lane, South Mimms, Hertfordshire, EN6 3QG, UK.
Fouad AtoufUnited States Pharmacopeial Convention, 12601 Twinbrook Pkwy, Rockville, Maryland, 20852, USA. biopubs@usp.org.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeErythropoietin (EPO) is a 165 amino acid protein that promotes the proliferation of erythrocytic progenitors. A decrease in endogenous EPO production causes anemia that can be treated with recombinant Human EPO (rHuEPO).

objectiveTo ensure the safety and efficacy of the rHuEPO, manufacturers must use analytical methods to demonstrate similarity across batches and between different products. To do this they need reference standards to validate their equipment and methods.

methodWe used peptide mapping, size-exclusion chromatography, glycoprofiling, and isoelectric focusing to analyze a rHuEPO reference standard.

resultsCharacterization demonstrates that our rHuEPO reference standard meets the criteria for quality.

conclusionThe rHuEPO reference standard is fit for purpose as a tool for validating system suitability and methods.

Indexed as

AnemiaErythropoietinHumansProtein BindingRecombinant ProteinsReference StandardsErythropoietinRecombinant ProteinsBiologicserythropoietinlyophilizationmanufacturingreference standards

Identifiers

PMID35292912
PMCPMC8986685

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.