Evidence map›Paper›PMID 31917583›Full record

ArticleMolecular pharmaceutics2020

The Impact of the Metal Interface on the Stability and Quality of a Therapeutic Fusion Protein.

Adrian P Defante, Cavan K Kalonia, Emma Keegan, Steven M Bishop, Hasige A Satish, Steven D Hudson, Paul V Santacroce

Abstract read
In one paragraph

Article in Molecular pharmaceutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Article
  2. Review
  3. 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

7 authors.

Adrian P DefanteMaterial Measurement Laboratory , National Institute of Standards and Technology (NIST) , Gaithersburg , Maryland 20899 , United States.ORCID 0000-0001-6590-1123
Cavan K KaloniaDosage Form Design and Development , AstraZeneca , Gaithersburg , Maryland 20878 , United States.
Emma KeeganDosage Form Design and Development , AstraZeneca , Gaithersburg , Maryland 20878 , United States.
Steven M BishopDosage Form Design and Development , AstraZeneca , Gaithersburg , Maryland 20878 , United States.
Hasige A SatishDosage Form Design and Development , AstraZeneca , Gaithersburg , Maryland 20878 , United States.
Steven D HudsonMaterial Measurement Laboratory , National Institute of Standards and Technology (NIST) , Gaithersburg , Maryland 20899 , United States.ORCID 0000-0002-3203-4833
Paul V SantacroceDosage Form Design and Development , AstraZeneca , Gaithersburg , Maryland 20878 , United States.

Funding

Intramural NIST DOC 9999-NIST
6 · The paper itself

Abstract

Subvisible particle formation, which occurs after the sterile filtration step of the fill/finish process, is a challenge that may occur during the development of biotherapeutics with complex molecular structures. Here, we show that a stainless steel pump head from a rotary piston pump produces more protein aggregates, past the limit of the acceptable quality range for subvisible particle counts, in comparison to a ceramic pump head. The quartz crystal microbalance was used to quantify the primary layer, proteins irreversibly adsorbed at the solid-liquid interface, and the secondary diffuse gel-like layer interacting on top of the primary layer. The results showed that the mass of protein irreversibly adsorbed onto stainless steel sensors is greater than on an aluminum oxide surface (ceramic pump mimic). This suggests that the amount of adsorbed protein plays a role in surface-induced protein aggregation at the solid-liquid interface.

Indexed as

AdsorptionAluminum OxideAntibodies, Monoclonal, HumanizedCeramicsDrug CompoundingDrug StabilityImmunoglobulin Fc FragmentsImmunoglobulin GProtein AggregatesQuartz Crystal Microbalance TechniquesStainless SteelSurface PropertiesTumor Necrosis Factor-alphaAluminum OxideAntibodies, Monoclonal, HumanizedImmunoglobulin Fc FragmentsImmunoglobulin GProtein AggregatesStainless SteelTumor Necrosis Factor-alphafusion proteinprotein adsorptionprotein aggregationsolid−liquid interfacesubvisible particles

Identifiers

PMID31917583
PMCPMC11025017

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.