Evidence map›Paper›PMID 29271693›Full record

ArticlemAbs

Integrated flow-through purification for therapeutic monoclonal antibodies processing.

Takamitsu Ichihara, Takao Ito, Yasuhiko Kurisu, Kevin Galipeau, Christopher Gillespie

Open access · goldAbstract read
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 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.2field-weighted citation impact, top 11% 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

9 citing papers in PubMed, 63 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. 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

5 authors at 2 institutions in 1 country.

Takamitsu Ichiharaa Astellas Pharma Inc. 2-5-1, Nihonbashi-Honcho , Chuo-ku , Tokyo , Japan.
Takao Itob Process solutions, Merck Ltd., DiverCity Tokyo Office Tower 15F, 1-1-20 Aomi , Koto-ku , Tokyo , Japan.ORCID 0000-0001-6224-5204
Yasuhiko Kurisub Process solutions, Merck Ltd., DiverCity Tokyo Office Tower 15F, 1-1-20 Aomi , Koto-ku , Tokyo , Japan.ORCID 0000-0003-3268-5625
Kevin Galipeauc Process solutions, MilliporeSigma , Bedford MA , USA.
Christopher Gillespiec Process solutions, MilliporeSigma , Bedford MA , USA.ORCID 0000-0001-5995-5483
Merck (Japan) · JPAstellas Pharma (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

An integrated all flow-through technology platform for the purification of therapeutic monoclonal antibodies (mAb), consisting of activated carbon and flow-through cation and anion exchange chromatography steps, can replace a conventional chromatography platform. This new platform was observed to have excellent impurity clearance at high mAb loadings with overall mAb yield exceeding 80%. Robust removal of DNA and host cell protein was demonstrated by activated carbon and a new flow-through cation exchange resin exhibited excellent clearance of mAb aggregate with high monomer recoveries. A ten-fold improvement of mAb loading was achieved compared to a traditional cation exchange resin designed for bind and elute mode. High throughput 96-well plate screening was used for process optimization, focusing on mAb loading and solution conditions. Optimum operating windows for integrated flow-through purification are proposed based on performance characteristics. The combination of an all flow-through polishing process presents significant opportunities for improvements in facility utilization and process economics.

Indexed as

Antibodies, MonoclonalCation Exchange ResinsChromatography, Ion ExchangeHumansAntibodies, MonoclonalCation Exchange Resinsactivated carboncontinuous manufacturingflow-through chromatographyintegrated processmonoclonal antibodypurification

Identifiers

PMID29271693
PMCPMC5825194
OpenAlexW2778198117

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.