Evidence map›Paper›PMID 35534190›Full record

ReviewMolecules and cells2022

Manufacturing Therapeutic Exosomes: from Bench to Industry.

So-Hee Ahn, Seung-Wook Ryu, Hojun Choi, Sangmin You, Jun Park, Chulhee Choi

Abstract readReview
In one paragraph

Review in Molecules and cells, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 111 papers.

0numbers the graph read from it
0cells of the map it votes in
111citing 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

111 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Natural Product-Derived Vesicles in Nanotherapeutics.Journal of extracellular vesicles · 2026
    Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Article
  20. Article

51 more citing papers are in PubMed but not listed here.

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.

So-Hee AhnILIAS Biologics Inc., Daejeon 34014, Korea.ORCID https://orcid.org/0000-0002-5079-545X
Seung-Wook RyuILIAS Biologics Inc., Daejeon 34014, Korea.ORCID https://orcid.org/0000-0003-1200-3594
Hojun ChoiILIAS Biologics Inc., Daejeon 34014, Korea.ORCID https://orcid.org/0000-0002-8657-9548
Sangmin YouILIAS Biologics Inc., Daejeon 34014, Korea.ORCID https://orcid.org/0000-0002-9114-0273
Jun ParkILIAS Biologics Inc., Daejeon 34014, Korea.ORCID https://orcid.org/0000-0003-4573-2558
Chulhee ChoiILIAS Biologics Inc., Daejeon 34014, Korea.ORCID https://orcid.org/0000-0001-5542-9136

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Process of manufacturing therapeutics exosome development for commercialization. The development of exosome treatment starts at the bench, and in order to be commercialized, it goes through the manufacturing, characterization, and formulation stages, production under Good Manufacturing Practice (GMP) conditions for clinical use, and close consultation with regulatory authorities. Exosome, a type of nanoparticles also known as small extracellular vesicles are gaining attention as novel therapeutics for various diseases because of their ability to deliver genetic or bioactive molecules to recipient cells. Although many pharmaceutical companies are gradually developing exosome therapeutics, numerous hurdles remain regarding manufacture of clinical-grade exosomes for therapeutic use. In this mini-review, we will discuss the manufacturing challenges of therapeutic exosomes, including cell line development, upstream cell culture, and downstream purification process. In addition, developing proper formulations for exosome storage and, establishing good manufacturing practice facility for producing therapeutic exosomes remains as challenges for developing clinicalgrade exosomes. However, owing to the lack of consensus regarding the guidelines for manufacturing therapeutic exosomes, close communication between regulators and companies is required for the successful development of exosome therapeutics. This review shares the challenges and perspectives regarding the manufacture and quality control of clinical grade exosomes.

Indexed as

ExosomesExtracellular VesiclesCell Culture TechniquesCell LineDrug Delivery Systemscharacterizationexosomemanufacturingpurityquality control

Identifiers

PMID35534190
PMCPMC9095511

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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.