Evidence map›Paper›PMID 40406926›Full record

ArticleBiotechnology progress

Use of LC-MS to characterize host cell protein removal during depth filtration.

Liang-Kai Chu, Ehsan Espah Borujeni, Xuankuo Xu, Andrew L Zydney

Abstract read
In one paragraph

Article in Biotechnology progress. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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.

Liang-Kai ChuDepartment of Chemical Engineering, The Pennsylvania State University, University Park, Pennsylvania, USA.
Ehsan Espah BorujeniBristol Myers Squibb, Biologics Development, Global Product Development and Supply, Devens, Massachusetts, USA.
Xuankuo XuBristol Myers Squibb, Biologics Development, Global Product Development and Supply, Devens, Massachusetts, USA.
Andrew L ZydneyDepartment of Chemical Engineering, The Pennsylvania State University, University Park, Pennsylvania, USA.ORCID 0000-0003-1865-9156

Funding

Bristol-Myers SquibbCancer Prevention Research Institute of Texas RP190682
6 · The paper itself

Abstract

The removal of host cell proteins (HCPs) is crucial in biopharmaceutical production, as residual impurities can impact product safety and efficacy. While a number of studies have demonstrated that depth filtration can provide significant HCP removal, there is little information on its effectiveness in removing specific HCPs. This study examines the application of liquid chromatography-mass spectrometry (LC-MS) to track HCP removal during depth filtration, providing a detailed analysis of HCP behavior with two commercial depth filters. Our findings reveal significant variability in HCP breakthrough behavior, with transmission patterns showing minimal correlation with either the protein isoelectric point or hydrophobicity, highlighting the unique behavior of individual HCPs. Both the X0SP and X0HC depth filters achieved almost complete removal of Lipoprotein Lipase, and the X0SP filter also effectively removed Lysosomal Acid Lipase (LAL), both known to degrade polysorbate in monoclonal antibody formulations. However, neither filter provided significant removal of Alpha-enolase, Carboxypeptidase D, Glutathione S-transferase, or Phospholipase B-like 2. The X0SP filter showed equal or better removal for 18 out of 20 problematic HCPs, with greater HCP removal seen at lower conductivity. This work provides a detailed framework for understanding and optimizing depth filtration processes, offering insights into the effectiveness of depth filters for removal of problematic HCPs.

Indexed as

FiltrationMass SpectrometryProteinsAnimalsCHO CellsChromatography, LiquidCricetulusLiquid Chromatography-Mass SpectrometryProteinsdepth filtrationdownstream processinghost cell proteinsLC‐MS

Identifiers

PMID40406926
PMCPMC12531921

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.