Evidence map›Paper›PMID 27570613›Full record

ReviewComputational and structural biotechnology journal2016

A Single-use Strategy to Enable Manufacturing of Affordable Biologics.

Renaud Jacquemart, Melissa Vandersluis, Mochao Zhao, Karan Sukhija, Navneet Sidhu, Jim Stout

Abstract readReview
In one paragraph

Review in Computational and structural biotechnology journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing 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

24 citing papers in PubMed.

  1. Review
  2. Vaccines · 2025
    Review
  3. Review
  4. Review
  5. Article
  6. Gene Delivery From Granular Scaffolds for Tunable Biologics Manufacturing.Small (Weinheim an der Bergstrasse, Germany) · 2024
    Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. CDMOs Play a Critical Role in the Biopharmaceutical Ecosystem.Frontiers in bioengineering and biotechnology · 2022
    Review
  16. Article
  17. Article
  18. Article
  19. Review
  20. 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

6 authors.

Renaud JacquemartNatrix Separations Inc., 5295 John Lucas Drive, Burlington, Ontario L7L 6A8, Canada.
Melissa VandersluisNatrix Separations Inc., 5295 John Lucas Drive, Burlington, Ontario L7L 6A8, Canada.
Mochao ZhaoNatrix Separations Inc., 5295 John Lucas Drive, Burlington, Ontario L7L 6A8, Canada.
Karan SukhijaNatrix Separations Inc., 5295 John Lucas Drive, Burlington, Ontario L7L 6A8, Canada.
Navneet SidhuNatrix Separations Inc., 5295 John Lucas Drive, Burlington, Ontario L7L 6A8, Canada.
Jim StoutNatrix Separations Inc., 5295 John Lucas Drive, Burlington, Ontario L7L 6A8, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The current processing paradigm of large manufacturing facilities dedicated to single product production is no longer an effective approach for best manufacturing practices. Increasing competition for new indications and the launch of biosimilars for the monoclonal antibody market have put pressure on manufacturers to produce at lower cost. Single-use technologies and continuous upstream processes have proven to be cost-efficient options to increase biomass production but as of today the adoption has been only minimal for the purification operations, partly due to concerns related to cost and scale-up. This review summarizes how a single-use holistic process and facility strategy can overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for affordable biologics. Technologies enabling high productivity, right-sized, small footprint, continuous, and automated upstream and downstream operations are evaluated in order to propose a concept for the flexible facility of the future.

Indexed as

Affinity membrane chromatographyAntibody manufacturing paradigmsB&E, bind and eluteCapEx, capital expensecGMP, current good manufacturing practiceCoG, cost of goodsContinuous bioprocessingDSP, downstream processEBA, expanded bed adsorptionEMA, European Medicines AgencyFDA, Food and Drug AdministrationFlexible, single-use facilitiesFT, flow throughHCP, host cell proteinMV, membrane volumeOpEx, operating expensePAT, process analytical technologyProcess economicsSMB, simulated moving bedUSP, upstream process

Identifiers

PMID27570613
PMCPMC4990569

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.