Evidence map›Paper›PMID 33491769›Full record

ReviewBiotechnology and bioengineering2021

A common framework for integrated and continuous biomanufacturing.

Jonathan Coffman, Mark Brower, Lisa Connell-Crowley, Sevda Deldari, Suzanne S Farid, Brian Horowski, Ujwal Patil, David Pollard, Maen Qadan, Steven Rose and 2 more

Open access · hybridAbstract readReview
In one paragraph

Review in Biotechnology and bioengineering, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
4.8field-weighted citation impact, top 4% 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

10 citing papers in PubMed, 78 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

12 authors at 9 institutions in 4 countries.

Jonathan CoffmanBioProcess Technology and Engineering, BioProcess Development, R&D, Astrazeneca, Gaithersburg, Maryland, USA.ORCID 0000-0002-4716-258X
Mark BrowerMerck and Company, Kennilworth, New Jersey, USA.ORCID 0000-0003-3277-4513
Lisa Connell-CrowleyJust Biotherapeutics, Seattle, Washington, USA.
Sevda DeldariBioProcess Technology and Engineering, BioProcess Development, R&D, Astrazeneca, Gaithersburg, Maryland, USA.ORCID 0000-0002-7678-3377
Suzanne S FaridDepartment of Biochemical Engineering, University College London, London, UK.ORCID 0000-0001-8155-0538
Brian HorowskiWood PLC, Aberdeen, UK.
Ujwal PatilBioProcess Technology and Engineering, BioProcess Development, R&D, Astrazeneca, Gaithersburg, Maryland, USA.ORCID 0000-0001-6675-7899
David PollardSartorius Stedim, Cambridge, Massachusetts, USA.
Maen QadanEli Lilly, Indianapolis, Indiana, USA.
Steven RoseBioProcess Technology and Engineering, BioProcess Development, R&D, Astrazeneca, Gaithersburg, Maryland, USA.ORCID 0000-0003-4013-7880
Eugene SchaeferJanssen R&D, Malvern, Pennsylvania, USA.ORCID 0000-0002-2937-8870
Joseph ShultzNovartis, Basel, Switzerland.
Bioprocess Control (Sweden) · SEEli Lilly (United States) · USJust Biotherapeutics (United States) · USLifeSensors (United States) · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USNovartis (Switzerland) · CHSartorius (United States) · USUniversity College London · GBWoodend Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There is a growing application of integrated and continuous bioprocessing (ICB) for manufacturing recombinant protein therapeutics produced from mammalian cells. At first glance, the newly evolved ICB has created a vast diversity of platforms. A closer inspection reveals convergent evolution: nearly all of the major ICB methods have a common framework that could allow manufacturing across a global ecosystem of manufacturers using simple, yet effective, equipment designs. The framework is capable of supporting the manufacturing of most major biopharmaceutical ICB and legacy processes without major changes in the regulatory license. This article reviews the ICB that are being used, or are soon to be used, in a GMP manufacturing setting for recombinant protein production from mammalian cells. The adaptation of the various ICB modes to the common ICB framework will be discussed, along with the pros and cons of such adaptation. The equipment used in the common framework is generally described. This review is presented in sufficient detail to enable discussions of IBC implementation strategy in biopharmaceutical companies and contract manufacturers, and to provide a road map for vendors equipment design. An example plant built on the common framework will be discussed. The flexibility of the plant is demonstrated with batches as small as 0.5 kg or as large as 500 kg. The yearly output of the plant is as much as 8 tons.

Indexed as

Biological ProductsDrug IndustryTechnology, PharmaceuticalRecombinant ProteinsBiological ProductsRecombinant Proteinsbiopharmaceuticaldual-column chromatographyintegrated continuous bioprocessingmammalian cellsperfusionprotein therapeutics

Identifiers

PMID33491769
PMCPMC8248397
OpenAlexW3121930667

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.