Evidence map›Paper›PMID 35182428›Full record

ReviewBiotechnology and bioengineering2022

Strategies to control therapeutic antibody glycosylation during bioprocessing: Synthesis and separation.

Elizabeth Edwards, Maria Livanos, Anja Krueger, Anne Dell, Stuart M Haslam, C Mark Smales, Daniel G Bracewell

Open access · hybridAbstract readReview
In one paragraph

Review in Biotechnology and bioengineering, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
7.2field-weighted citation impact, top 2% 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

27 citing papers in PubMed, 56 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

7 authors at 3 institutions in 2 countries.

Elizabeth EdwardsDepartment of Biochemical Engineering, University College London, London, UK.
Maria LivanosDepartment of Biochemical Engineering, University College London, London, UK.
Anja KruegerDepartment of Life Sciences, Imperial College London, London, UK.
Anne DellDepartment of Life Sciences, Imperial College London, London, UK.
Stuart M HaslamDepartment of Life Sciences, Imperial College London, London, UK.
C Mark SmalesSchool of Biosciences, Division of Natural Sciences, University of Kent, Canterbury, UK.ORCID 0000-0002-2762-4724
Daniel G BracewellDepartment of Biochemical Engineering, University College London, London, UK.ORCID 0000-0003-3866-3304
Imperial College London · GBUniversity College London · GBUniversity of Kent · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Glycosylation can be a critical quality attribute in biologic manufacturing. In particular, it has implications on the half-life, immunogenicity, and pharmacokinetics of therapeutic monoclonal antibodies (mAbs), and must be closely monitored throughout drug development and manufacturing. To address this, advances have been made primarily in upstream processing, including mammalian cell line engineering, to yield more predictably glycosylated mAbs and the addition of media supplements during fermentation to manipulate the metabolic pathways involved in glycosylation. A more robust approach would be a conjoined upstream-downstream processing strategy. This could include implementing novel downstream technologies, such as the use of Fc γ-based affinity ligands for the separation of mAb glycovariants. This review highlights the importance of controlling therapeutic antibody glycosylation patterns, the challenges faced in terms of glycosylation during mAb biosimilar development, current efforts both upstream and downstream to control glycosylation and their limitations, and the need for research in the downstream space to establish holistic and consistent manufacturing processes for the production of antibody therapies.

Indexed as

Antineoplastic Agents, ImmunologicalBiosimilar PharmaceuticalsAnimalsAntibodies, MonoclonalGlycosylationMammalsAntibodies, MonoclonalAntineoplastic Agents, ImmunologicalBiosimilar PharmaceuticalsantibodiesbiosimilarsCQAsdownstream glycosylation bioprocessingmAbsN-glycosylation

Identifiers

PMID35182428
PMCPMC9310845
OpenAlexW4213238033

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.