Evidence map›Paper›PMID 35447733›Full record

ArticleBioengineering (Basel, Switzerland)2022

Improved Titer in Late-Stage Mammalian Cell Culture Manufacturing by Re-Cloning.

Qin He, Matthew S Rehmann, Jun Tian, Jianlin Xu, Luzmary Sabino, Erik Vandermark, Ziev Basson, Iris Po, Kathleen Bierilo, Gabi Tremml and 6 more

Open access · goldAbstract read
In one paragraph

Article in Bioengineering (Basel, Switzerland), 2022. 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
0.4field-weighted citation impact, top 42% 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, 7 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

16 authors at 1 institution in 1 country.

Qin HeGlobal Product Development and Supply, Bristol Myers Squibb Company, Devens, MA 01434, USA.
Matthew S RehmannGlobal Product Development and Supply, Bristol Myers Squibb Company, Devens, MA 01434, USA.
Jun TianGlobal Product Development and Supply, Bristol Myers Squibb Company, Devens, MA 01434, USA.
Jianlin XuGlobal Product Development and Supply, Bristol Myers Squibb Company, Devens, MA 01434, USA.ORCID 0000-0002-6441-0696
Luzmary SabinoGlobal Product Development and Supply, Bristol Myers Squibb Company, Devens, MA 01434, USA.
Erik VandermarkGlobal Product Development and Supply, Bristol Myers Squibb Company, Devens, MA 01434, USA.
Ziev BassonGlobal Product Development and Supply, Bristol Myers Squibb Company, Devens, MA 01434, USA.
Iris PoGlobal Product Development and Supply, Bristol Myers Squibb Company, New Brunswick, NJ 08903, USA.
Kathleen BieriloGlobal Product Development and Supply, Bristol Myers Squibb Company, New Brunswick, NJ 08903, USA.
Gabi TremmlGlobal Product Development and Supply, Bristol Myers Squibb Company, New Brunswick, NJ 08903, USA.
Giovanni RizziGlobal Product Development and Supply, Bristol Myers Squibb Company, New Brunswick, NJ 08903, USA.
Erik F LangsdorfGlobal Product Development and Supply, Bristol Myers Squibb Company, New Brunswick, NJ 08903, USA.
Nan-Xin QianGlobal Product Development and Supply, Bristol Myers Squibb Company, Devens, MA 01434, USA.
Michael C BorysGlobal Product Development and Supply, Bristol Myers Squibb Company, Devens, MA 01434, USA.
Anurag KhetanGlobal Product Development and Supply, Bristol Myers Squibb Company, New Brunswick, NJ 08903, USA.
Zheng-Jian LiGlobal Product Development and Supply, Bristol Myers Squibb Company, Devens, MA 01434, USA.ORCID 0000-0002-1941-4145
Bristol-Myers Squibb (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Improving productivity to reduce the cost of biologics manufacturing and ensure that therapeutics can reach more patients remains a major challenge faced by the biopharmaceutical industry. Chinese hamster ovary (CHO) cell lines are commonly prepared for biomanufacturing by single cell cloning post-transfection and recovery, followed by lead clone screening, generation of a research cell bank (RCB), cell culture process development, and manufacturing of a master cell bank (MCB) to be used in early phase clinical manufacturing. In this study, it was found that an additional round of cloning and clone selection from an established monoclonal RCB or MCB (i.e., re-cloning) significantly improved titer for multiple late phase monoclonal antibody upstream processes. Quality attributes remained comparable between the processes using the parental clones and the re-clones. For two CHO cells expressing different antibodies, the re-clone performance was successfully scaled up at 500-L or at 2000-L bioreactor scales, demonstrating for the first time that the re-clone is suitable for late phase and commercial manufacturing processes for improvement of titer while maintaining comparable product quality to the early phase process.

Indexed as

biologics manufacturingcell culture platformChinese hamster ovary cellsre-cloningtiter

Identifiers

PMID35447733
PMCPMC9030702
OpenAlexW4223992806

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.