Evidence map›Paper›PMID 33522595›Full record

ArticleBiotechnology and bioengineering2021

The design basis for the integrated and continuous biomanufacturing framework.

Jon Coffman, Kenneth Bibbo, Mark Brower, Robert Forbes, Nicholas Guros, Brian Horowski, Rick Lu, Rajiv Mahajan, Ujwal Patil, Steven Rose and 1 more

Abstract read
In one paragraph

Article 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Article
  6. Review
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

11 authors.

Jon CoffmanBiopharmaceutical Development, R&D, AstraZeneca, Gaithersburg, Maryland, USA.ORCID 0000-0002-4716-258X
Kenneth BibboUS Lifescience, Wood PLC, Philadelphia, Pennsylvania, USA.
Mark BrowerMerck and Co., Inc., Kenilworth, New Jersey, USA.
Robert ForbesUS Lifescience, Wood PLC, Philadelphia, Pennsylvania, USA.
Nicholas GurosBiopharmaceutical Development, R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Brian HorowskiUS Lifescience, Wood PLC, Philadelphia, Pennsylvania, USA.
Rick LuOperations Management, Supply Biologics, AstraZeneca, Gaithersburg, Maryland, USA.
Rajiv MahajanOperations Management, Supply Biologics, AstraZeneca, Gaithersburg, Maryland, USA.
Ujwal PatilBiopharmaceutical Development, R&D, AstraZeneca, Gaithersburg, Maryland, USA.ORCID 0000-0001-6675-7899
Steven RoseBiopharmaceutical Development, R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Joseph ShultzNovartis, Basel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

An 8 ton per year manufacturing facility is described based on the framework for integrated and continuous bioprocessing (ICB) common to all known biopharmaceutical implementations. While the output of this plant rivals some of the largest fed-batch plants in the world, the equipment inside the plant is relatively small: the plant consists of four 2000 L single-use bioreactors and has a maximum flow rate of 13 L/min. The equipment and facility for the ICB framework is described in sufficient detail to allow biopharmaceutical companies, vendors, contract manufacturers to build or buy their own systems. The design will allow the creation of a global ICB ecosystem that will transform biopharmaceutical manufacturing. The design is fully backward compatible with legacy fed-batch processes. A clinical production scale is described that can produce smaller batch sizes with the same equipment as that used at the commercial scale. The design described allows the production of as little as 10 g to nearly 35 kg of drug substance per day.

Indexed as

Antibodies, MonoclonalBatch Cell Culture TechniquesBioreactorsModels, TheoreticalTechnology, PharmaceuticalAntibodies, Monoclonalbiopharmaceuticaldual-column chromatographyintegrated continuous bioprocessingmammalian cellsperfusionprotein therapeutics

Identifiers

PMID33522595
PMCPMC8453788

What OpenQuestion holds

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LicenceCC BY-NC
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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.