Evidence map›Paper›PMID 33743183›Full record

ArticleBiotechnology progress2021

Introduction and clearance of beta-glucan in the downstream processing of monoclonal antibodies.

Simon Kluters, Karin Steinhauser, Roland Pfänder, Joey Studts

Open access · hybridAbstract read
In one paragraph

Article in Biotechnology progress, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 52% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. 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

4 authors at 1 institution in 1 country.

Simon KlutersLate Stage DSP Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Baden-Württemberg, Germany.ORCID 0000-0002-3619-6821
Karin SteinhauserLate Stage DSP Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Baden-Württemberg, Germany.
Roland PfänderLate Stage DSP Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Baden-Württemberg, Germany.
Joey StudtsLate Stage DSP Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Baden-Württemberg, Germany.
Boehringer Ingelheim (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

β-Glucan process-related impurities can be introduced into biopharmaceutical products via upstream or downstream processing or via excipients. This study obtained a comprehensive process-mapping dataset for five monoclonal antibodies to assess β-glucan introduction and clearance during development and production runs at various scales. Overall, 198 data points were available for analysis. The greatest β-glucan concentrations were found in the depth-filtration filtrate (37-2,745 pg/ml). Load volume correlated with β-glucan concentration in the filtrate, whereas flush volume was of secondary importance. Cation-exchange chromatography significantly cleared β-glucans. Furthermore, β-glucan leaching from the Planova 20N virus removal filter was reduced by increasing the flush volume (1 vs. 10 L/m

Indexed as

beta-GlucansAntibodies, MonoclonalExcipientsFiltrationUltrafiltrationAntibodies, Monoclonalbeta-GlucansExcipientsdepth filtrationdownstream processingmonoclonal antibodyprocess-related impuritiesβ-glucan

Identifiers

PMID33743183
PMCPMC9285507
OpenAlexW3136122954

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.