Evidence map›Paper›PMID 30272677›Full record

ArticleNature biotechnology2018

On-demand manufacturing of clinical-quality biopharmaceuticals.

Laura E Crowell, Amos E Lu, Kerry R Love, Alan Stockdale, Steven M Timmick, Di Wu, Yu Annie Wang, William Doherty, Alexandra Bonnyman, Nicholas Vecchiarello and 18 more

Abstract read
In one paragraph

Article in Nature biotechnology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing 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

40 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Brain physiome: A concept bridgingBioactive materials · 2022
    Review
  14. Article
  15. Article
  16. Article
  17. Engineered SARS-CoV-2 receptor binding domain improves manufacturability in yeast and immunogenicity in mice.Proceedings of the National Academy of Sciences of the United States of America · 2021
    Article
  18. Article
  19. Article
  20. Bioengineering (Basel, Switzerland) · 2021
    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

28 authors.

Laura E CrowellKoch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.ORCID http://orcid.org/0000-0002-3371-7193
Amos E LuDepartment of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
Kerry R LoveKoch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
Alan StockdaleKoch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
Steven M TimmickDepartment of Chemical and Biological Engineering, Rensselaer Polytechnic Institute, Troy, New York, USA.
Di WuBarnett Institute and Department of Chemistry and Chemical Biology, Northeastern University, Boston, Massachusetts, USA.
Yu Annie WangBarnett Institute and Department of Chemistry and Chemical Biology, Northeastern University, Boston, Massachusetts, USA.ORCID http://orcid.org/0000-0001-6872-6375
William DohertyKoch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
Alexandra BonnymanKoch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
Nicholas VecchiarelloDepartment of Chemical and Biological Engineering, Rensselaer Polytechnic Institute, Troy, New York, USA.
Chaz GoodwineDepartment of Chemical and Biological Engineering, Rensselaer Polytechnic Institute, Troy, New York, USA.
Lisa BradburyPall Life Sciences, Westborough, Massachusetts, USA.
Joseph R BradyKoch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
John J ClarkKoch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
Noelle A ColantKoch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
Aleksandar CvetkovicPall Life Sciences, Westborough, Massachusetts, USA.
Neil C DalvieKoch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
Diana LiuKoch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
Yanjun LiuBarnett Institute and Department of Chemistry and Chemical Biology, Northeastern University, Boston, Massachusetts, USA.
Craig A MascarenhasKoch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
Catherine B MatthewsKoch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
Nicholas J MozdzierzKoch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
Kartik A ShahKoch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
Shiaw-Lin WuBioAnalytix Inc., Cambridge, Massachusetts, USA.
William S HancockBarnett Institute and Department of Chemistry and Chemical Biology, Northeastern University, Boston, Massachusetts, USA.
Richard D BraatzDepartment of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.ORCID http://orcid.org/0000-0003-4304-3484
Steven M CramerDepartment of Chemical and Biological Engineering, Rensselaer Polytechnic Institute, Troy, New York, USA.
J Christopher LoveKoch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.ORCID http://orcid.org/0000-0003-0921-3144

Funding

VIRUS PRODUCTION COREP30CA014051 · NCI · MASSACHUSETTS INSTITUTE OF TECHNOLOGY · PI MATTHEW G. VANDER HEIDEN · 1985 to 2026
$93.9M
Interdepartmental Biotechnology Training ProgramT32GM008334 · NIGMS · MASSACHUSETTS INSTITUTE OF TECHNOLOGY · PI WITTRUP, KARL DANE · 1989 to 2018
$15.2M
NCI NIH HHS P30 CA014051NIGMS NIH HHS T32 GM008334
6 · The paper itself

Abstract

Conventional manufacturing of protein biopharmaceuticals in centralized, large-scale, single-product facilities is not well-suited to the agile production of drugs for small patient populations or individuals. Previous solutions for small-scale manufacturing are limited in both process reproducibility and product quality, owing to their complicated means of protein expression and purification. We describe an automated, benchtop, multiproduct manufacturing system, called Integrated Scalable Cyto-Technology (InSCyT), for the end-to-end production of hundreds to thousands of doses of clinical-quality protein biologics in about 3 d. Unlike previous systems, InSCyT includes fully integrated modules for sustained production, efficient purification without the use of affinity tags, and formulation to a final dosage form of recombinant biopharmaceuticals. We demonstrate that InSCyT can accelerate process development from sequence to purified drug in 12 weeks. We used integrated design to produce human growth hormone, interferon α-2b and granulocyte colony-stimulating factor with highly similar processes on this system and show that their purity and potency are comparable to those of marketed reference products.

Identifiers

PMID30272677
PMCPMC6443493

What OpenQuestion holds

Textmetadata
LicenceTDM
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.