Evidence map›Paper›PMID 28035628›Full record

ArticlePharmaceutical research2017

Effects of Histidine and Sucrose on the Biophysical Properties of a Monoclonal Antibody.

Youngbin Baek, Nripen Singh, Abhiram Arunkumar, Andrew L Zydney

Abstract read
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In one paragraph

Article in Pharmaceutical research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.6field-weighted citation impact, top 16% 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

11 citing papers in PubMed, 39 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

4 authors at 2 institutions in 1 country.

Youngbin BaekDepartment of Chemical Engineering, The Pennsylvania State University, University Park, Pennsylvania, 16802, USA.
Nripen SinghBristol-Myers Squibb, Global Manufacturing and Supply, Devens, Massachusetts, 01434, USA.
Abhiram ArunkumarBristol-Myers Squibb, Global Manufacturing and Supply, Devens, Massachusetts, 01434, USA.
Andrew L ZydneyDepartment of Chemical Engineering, The Pennsylvania State University, University Park, Pennsylvania, 16802, USA. zydney@engr.psu.edu.ORCID 0000-0003-1865-9156
Bristol-Myers Squibb (United States) · USPennsylvania State University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeHistidine is a commonly used buffer in formulation of monoclonal antibodies (mAb), often with excipients like sucrose. The objective of this study was to examine the effects of both histidine and sucrose on the biophysical characteristics of a mAb.

methodsThe hydrodynamic radius of the mAb was determined by dynamic light scattering and confirmed by size exclusion chromatography. Data were also obtained for the osmotic virial coefficients (from osmotic pressure measurements), the solution viscosity, and the mAb thermal stability (using differential scanning calorimetry) at selected conditions.

resultsThere were no significant changes in mAb conformation / stability as determined by DSC. The hydrodynamic radius initially increased with increasing histidine concentration, going through a maximum at a histidine concentration of about 20 mM. The addition of sucrose increased the mAb hydrodynamic radius at all histidine concentrations by about 0.5 nm. The observed effects of histidine and sucrose on the hydrodynamic radius were also reflected in changes in the osmotic pressure and solution viscosity.

conclusionsThese results provide important insights into the effects of both histidine and sucrose on the behavior of concentrated mAb solutions, including the potential impact on ultrafiltration / diafiltration processes.

Indexed as

Antibodies, MonoclonalCalorimetry, Differential ScanningChemistry, PharmaceuticalExcipientsHistidineHumansHydrogen-Ion ConcentrationProtein AggregatesProtein ConformationProtein StabilitySucroseTemperatureViscosityAntibodies, MonoclonalExcipientsHistidineProtein AggregatesSucroseexcipientsformulationlight scatteringmonoclonal antibodyphysical characterization

Identifiers

PMID28035628
OpenAlexW2565843771

What OpenQuestion holds

Textmetadata
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.