Evidence map›Paper›PMID 34577595›Full record

ReviewPharmaceuticals (Basel, Switzerland)2021

Manufacturing Bacteriophages (Part 2 of 2): Formulation, Analytics and Quality Control Considerations.

Carolina Moraes de Souza, Tayfun Tanir, Marvin Orellana, Aster Escalante, Michael Sandor Koeris

Abstract readReview
In one paragraph

Review in Pharmaceuticals (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Review
  2. Review
  3. Isolation and characterisation of a novel Stenotrophomonas maltophilia phage vB_SmaS_BCU-1 with evaluation of mammalian cell safety.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026
    Article
  4. Review
  5. Review
  6. Beyond Antibiotics: What the Future Holds.Antibiotics (Basel, Switzerland) · 2024
    Review
  7. Review
  8. NovelPharmaceutics · 2022
    Article
  9. Review
  10. Article
  11. 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

5 authors.

Carolina Moraes de SouzaAmgen Bioprocessing Center, Department of Biological Engineering and Management, Henry E. Riggs School of Applied Life Sciences, Keck Graduate Institute, Claremont, CA 91711, USA.
Tayfun TanirAmgen Bioprocessing Center, Department of Biological Engineering and Management, Henry E. Riggs School of Applied Life Sciences, Keck Graduate Institute, Claremont, CA 91711, USA.
Marvin OrellanaAmgen Bioprocessing Center, Department of Biological Engineering and Management, Henry E. Riggs School of Applied Life Sciences, Keck Graduate Institute, Claremont, CA 91711, USA.
Aster EscalanteAmgen Bioprocessing Center, Department of Biological Engineering and Management, Henry E. Riggs School of Applied Life Sciences, Keck Graduate Institute, Claremont, CA 91711, USA.
Michael Sandor KoerisAmgen Bioprocessing Center, Department of Biological Engineering and Management, Henry E. Riggs School of Applied Life Sciences, Keck Graduate Institute, Claremont, CA 91711, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Within this second piece of the two-part series of phage manufacturing considerations, we are examining the creation of a drug product from a drug substance in the form of formulation, through to fill-finish. Formulation of a drug product, in the case of bacteriophage products, is often considered only after many choices have been made in the development and manufacture of a drug substance, increasing the final product development timeline and difficulty of achieving necessary performance parameters. As with the preceding review in this sequence, we aim to provide the reader with a framework to be able to consider pharmaceutical development choices for the formulation of a bacteriophage-based drug product. The intent is to sensitize and highlight the tradeoffs that are necessary in the development of a finished drug product, and to be able to take the entire spectrum of tradeoffs into account, starting with early-stage R&D efforts. Furthermore, we are arming the reader with an overview of historical and current analytical methods with a special emphasis on most relevant and most widely available methods. Bacteriophages pose some challenges that are related to but also separate from eukaryotic viruses. Last, but not least, we close this two-part series by briefly discussing quality control (QC) aspects of a bacteriophage-based product, taking into consideration the opportunities and challenges that engineered bacteriophages uniquely present and offer.

Indexed as

analyticalbacteriophagedrug productdrug substancefill-finishformulationmanufacturingphage therapy

Identifiers

PMID34577595
PMCPMC8467454

What OpenQuestion holds

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LicenceCC BY
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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.