Evidence map›Paper›PMID 33122796›Full record

ArticleScientific reports2020

Modified aptamers as reagents to characterize recombinant human erythropoietin products.

Wojciech Jankowski, H A Daniel Lagassé, William C Chang, Joseph McGill, Katarzyna I Jankowska, Amy D Gelinas, Nebojsa Janjic, Zuben E Sauna

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Scientific reports, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.7field-weighted citation impact, top 32% of its field
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

8 citing papers in PubMed, 12 citations in OpenAlex.

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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 at 2 institutions in 1 country.

Wojciech Jankowski *Hemostasis Branch, Division of Plasma Protein Therapeutics, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
H A Daniel Lagassé *Hemostasis Branch, Division of Plasma Protein Therapeutics, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
William C ChangHemostasis Branch, Division of Plasma Protein Therapeutics, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Joseph McGillHemostasis Branch, Division of Plasma Protein Therapeutics, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Katarzyna I JankowskaLaboratory of Cellular Hematology, Division of Blood Components and Devices, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Amy D GelinasSomaLogic, Inc., Boulder, CO, USA.
Nebojsa Janjic *SomaLogic, Inc., Boulder, CO, USA. njanjic@somalogic.com.
Zuben E Sauna *Hemostasis Branch, Division of Plasma Protein Therapeutics, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. zuben.sauna@fda.hhs.gov.
Center for Biologics Evaluation and Research · USSomaLogic (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Reliable and reproducible monitoring of the conformational state of therapeutic protein products remains an unmet technological need. This need is amplified by the increasing number of biosimilars entering the drug development pipeline as many branded biologics are reaching the end of their market exclusivity period. Availability of methods to better characterize protein conformation may improve detection of counterfit and unlicensed therapeutic proteins. In this study, we report the use of a set of modified DNA aptamers with enhanced chemical diversity to probe the conformational state of 12 recombinant human erythropoietin (rHuEPO) therapeutic protein products; one FDA-licensed rHuEPO originator biological product, three rHuEPO products that are approved for marketing in the US or EU as biosimilars, and eight rHuEPO products that are not approved for marketing in the US or EU. We show that several of these modified aptamers are able to distinguish rHuEPO reference products or approved biosimilars from non-licensed rHuEPO products on the basis of differences in binding kinetics and equilibrium affinity constants. These reagents exhibit sensitivity to the conformational integrity of various forms of rHuEPO and as such represent powerful, simple-to-use analytical tools to monitor the conformational integrity of therapeutic-proteins during manufacture and to screen for and identify both substandard and counterfeit products.

Indexed as

Aptamers, NucleotideBiosimilar PharmaceuticalsErythropoietinHumansIndicators and ReagentsMarketingProtein ConformationRecombinant ProteinsAptamers, NucleotideBiosimilar PharmaceuticalsEPO protein, humanErythropoietinIndicators and ReagentsRecombinant Proteins

Identifiers

PMID33122796
PMCPMC7596557
OpenAlexW3094836579

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.