Evidence map›Paper›PMID 29958062›Full record

ArticlemAbs

Heterologous recombinant expression of non-originator NISTmAb.

Lila Kashi, Katharina Yandrofski, Renae J Preston, Luke W Arbogast, John P Giddens, John P Marino, John E Schiel, Zvi Kelman

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

Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 43% 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

4 citing papers in PubMed, 6 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 1 institution in 1 country.

Lila Kashia Biomolecular Labeling Laboratory , National Institute of Standards and Technology and Institute for Bioscience and Biotechnology Research, University of Maryland , Rockville , MD , USA.
Katharina Yandrofskib National Institute of Standards and Technology , Institute for Bioscience and Biotechnology Research , Rockville , MD , USA.
Renae J Prestona Biomolecular Labeling Laboratory , National Institute of Standards and Technology and Institute for Bioscience and Biotechnology Research, University of Maryland , Rockville , MD , USA.
Luke W Arbogastb National Institute of Standards and Technology , Institute for Bioscience and Biotechnology Research , Rockville , MD , USA.ORCID 0000-0001-6871-450X
John P Giddensb National Institute of Standards and Technology , Institute for Bioscience and Biotechnology Research , Rockville , MD , USA.
John P Marinob National Institute of Standards and Technology , Institute for Bioscience and Biotechnology Research , Rockville , MD , USA.
John E Schielb National Institute of Standards and Technology , Institute for Bioscience and Biotechnology Research , Rockville , MD , USA.
Zvi Kelmana Biomolecular Labeling Laboratory , National Institute of Standards and Technology and Institute for Bioscience and Biotechnology Research, University of Maryland , Rockville , MD , USA.
National Institute of Standards and Technology · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The successful development and regulatory approval of originator and biosimilar therapeutic proteins requires a systems approach to upstream and downstream processing as well as product characterization and quality control. Innovation in process design and control, product characterization strategies, and data integration represent an ecosystem whose concerted advancement may reduce time-to-market and further improve comparability and biosimilarity programs. The biopharmaceutical community has made great strides to this end, yet there currently exists no pre-competitive monoclonal antibody (mAb) expression platform for open innovation. Here, we describe the development and initial expression of an intended copy of the NISTmAb using three non-originator murine cell lines. It was found that, without optimization and in culture flasks, all three cell lines produce approximately 100 mg mAb per liter of culture. Sodium dodecyl sulfate polyacrylamide gel electrophoresis, size-exclusion chromatography, nuclear magnetic resonance spectroscopy, intact mass spectrometry, and surface plasmon resonance were used to demonstrate that the products of all three cell lines embody quality attributes with a sufficient degree of sameness to the NISTmAb Reference Material 8671 to warrant further bioreactor studies, process improvements and optimization. The implications of the work with regard to pre-competitive innovation to support process design and feedback control, comparability and biosimilarity assessments, and process analytical technologies are discussed.

Indexed as

Amino Acid SequenceAnimalsAntibodies, MonoclonalBiosimilar PharmaceuticalsCell LineChromatography, LiquidElectrophoresis, Polyacrylamide GelHumansImmunoglobulin GMagnetic Resonance SpectroscopyQuality ControlRecombinant ProteinsReference StandardsTandem Mass SpectrometryAntibodies, MonoclonalBiosimilar PharmaceuticalsImmunoglobulin GRecombinant ProteinsBiopharmaceuticalbiosimilarbiotherapeuticmass spectrometrymonoclonal antibodyNISTmAbNMR

Identifiers

PMID29958062
PMCPMC6152460
OpenAlexW2810915036

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.