Evidence map›Paper›PMID 26506568›Full record

ArticleProtein expression and purification2016

A scalable low-cost cGMP process for clinical grade production of the HIV inhibitor 5P12-RANTES in Pichia pastoris.

Fabrice Cerini, Hubert Gaertner, Knut Madden, Ilya Tolstorukov, Scott Brown, Bram Laukens, Nico Callewaert, Jay C Harner, Anna M Oommen, John T Harms and 8 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Protein expression and purification, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.7field-weighted citation impact, top 16% of its field
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

13 citing papers in PubMed, 20 citations in OpenAlex.

  1. Article
  2. Endogenous Peptide Inhibitors of HIV Entry.Advances in experimental medicine and biology · 2022
    Article
  3. Article
  4. Sustained release silk fibroin discs: Antibody and protein delivery for HIV prevention.Journal of controlled release : official journal of the Controlled Release Society · 2019
    Article
  5. Vaginal rings with exposed cores for sustained delivery of the HIV CCR5 inhibitor 5P12-RANTES.Journal of controlled release : official journal of the Controlled Release Society · 2019
    Article
  6. Rapid and low-cost multiplex synthesis of chemokine analogs.The Journal of biological chemistry · 2018
    Article
  7. Article
  8. On-demand microbicide products: design matters.Drug delivery and translational research · 2017
    Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. 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

18 authors at 7 institutions in 3 countries.

Fabrice CeriniDepartment of Pathology and Immunology, Faculty of Medicine, University of Geneva, Geneva, Switzerland.
Hubert GaertnerDepartment of Pathology and Immunology, Faculty of Medicine, University of Geneva, Geneva, Switzerland.
Knut MaddenBioGrammatics Inc., Carlsbad, CA 92011, USA.
Ilya TolstorukovBioGrammatics Inc., Carlsbad, CA 92011, USA; Keck Graduate Institute, Claremont, CA, USA.
Scott BrownBiologics Process Development, Inc., Poway, CA 92064, USA.
Bram LaukensDepartment of Medical Protein Research, VIB-UGent, Ghent, Belgium; Department of Biochemistry and Microbiology, Laboratory for Protein Biochemistry and Biomolecular Engineering, Ghent University, Ghent, Belgium.
Nico CallewaertDepartment of Medical Protein Research, VIB-UGent, Ghent, Belgium; Department of Biochemistry and Microbiology, Laboratory for Protein Biochemistry and Biomolecular Engineering, Ghent University, Ghent, Belgium.
Jay C HarnerUniversity of Nebraska-Lincoln Biological Process Development Facility, College of Engineering, University of Nebraska-Lincoln, Lincoln, NE, USA.
Anna M OommenUniversity of Nebraska-Lincoln Biological Process Development Facility, College of Engineering, University of Nebraska-Lincoln, Lincoln, NE, USA.
John T HarmsUniversity of Nebraska-Lincoln Biological Process Development Facility, College of Engineering, University of Nebraska-Lincoln, Lincoln, NE, USA.
Anthony R SumpUniversity of Nebraska-Lincoln Biological Process Development Facility, College of Engineering, University of Nebraska-Lincoln, Lincoln, NE, USA.
Robert C SealockUniversity of Nebraska-Lincoln Biological Process Development Facility, College of Engineering, University of Nebraska-Lincoln, Lincoln, NE, USA.
Dustin J PetersonUniversity of Nebraska-Lincoln Biological Process Development Facility, College of Engineering, University of Nebraska-Lincoln, Lincoln, NE, USA.
Scott K JohnsonUniversity of Nebraska-Lincoln Biological Process Development Facility, College of Engineering, University of Nebraska-Lincoln, Lincoln, NE, USA.
Stephan B AbramsonLifeSci Partners, LLC, Vancouver, WA 98686-2811, USA.
Michael MeagherUniversity of Nebraska-Lincoln Biological Process Development Facility, College of Engineering, University of Nebraska-Lincoln, Lincoln, NE, USA.
Robin OffordThe Mintaka Foundation for Medical Research, Geneva, Switzerland.
Oliver HartleyDepartment of Pathology and Immunology, Faculty of Medicine, University of Geneva, Geneva, Switzerland; The Mintaka Foundation for Medical Research, Geneva, Switzerland. Electronic address: oliver.hartley@unige.ch.
University of Nebraska–Lincoln · USMintaka Foundation for Medical Research · CHUniversity of Geneva · CHGhent University · BEHealthPartners · USKeck Graduate Institute · USVIB-UGent Center for Medical Biotechnology · BE

Funding

Wellcome Trust 090561Wellcome Trust 104252
6 · The paper itself

Abstract

In the continued absence of an effective anti-HIV vaccine, approximately 2 million new HIV infections occur every year, with over 95% of these in developing countries. Calls have been made for the development of anti-HIV drugs that can be formulated for topical use to prevent HIV transmission during sexual intercourse. Because these drugs are principally destined for use in low-resource regions, achieving production costs that are as low as possible is an absolute requirement. 5P12-RANTES, an analog of the human chemokine protein RANTES/CCL5, is a highly potent HIV entry inhibitor which acts by achieving potent blockade of the principal HIV coreceptor, CCR5. Here we describe the development and optimization of a scalable low-cost production process for 5P12-RANTES based on expression in Pichia pastoris. At pilot (150 L) scale, this cGMP compliant process yielded 30 g of clinical grade 5P12-RANTES. As well as providing sufficient material for the first stage of clinical development, this process represents an important step towards achieving production of 5P12-RANTES at a cost and scale appropriate to meet needs for topical HIV prevention worldwide.

Indexed as

PichiaAnti-HIV AgentsBioreactorsChemokines, CCChromatography, High Pressure LiquidChromatography, Ion ExchangeFermentationHIVHIV InfectionsHumansInhibitory Concentration 50Pilot ProjectsVirus Internalization5P12-RANTESAnti-HIV AgentsChemokines, CC5P12-RANTESBiopharmaceuticalCCR5cGMPChemokineHIVMicrobicidePichiaProcess developmentYeast

Identifiers

PMID26506568
PMCPMC4725576
OpenAlexW1804806370

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.