Evidence map›Paper›PMID 26818839›Full record

ArticlePharmaceutical research2016

Stabilization of Live Attenuated Influenza Vaccines by Freeze Drying, Spray Drying, and Foam Drying.

Phillip M Lovalenti, Jeff Anderl, Luisa Yee, Van Nguyen, Behnaz Ghavami, Satoshi Ohtake, Atul Saxena, Thomas Voss, Vu Truong-Le

Abstract read
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Article in Pharmaceutical research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
4.6field-weighted citation impact, top 5% 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

21 citing papers in PubMed, 60 citations in OpenAlex.

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  7. A guide to oral vaccination: Highlighting electrospraying as a promising manufacturing technique toward a successful oral vaccine development.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2022
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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

9 authors at 2 institutions in 1 country.

Phillip M LovalentiAridis Pharmaceuticals, 5941 Optical Court, San Jose, California, 95138, USA.
Jeff AnderlAridis Pharmaceuticals, 5941 Optical Court, San Jose, California, 95138, USA.
Luisa YeeAridis Pharmaceuticals, 5941 Optical Court, San Jose, California, 95138, USA.
Van NguyenAridis Pharmaceuticals, 5941 Optical Court, San Jose, California, 95138, USA.
Behnaz GhavamiAridis Pharmaceuticals, 5941 Optical Court, San Jose, California, 95138, USA.
Satoshi OhtakeAridis Pharmaceuticals, 5941 Optical Court, San Jose, California, 95138, USA.
Atul SaxenaAridis Pharmaceuticals, 5941 Optical Court, San Jose, California, 95138, USA.
Thomas VossSRI International, Harrisonburg, Virginia, USA.
Vu Truong-LeAridis Pharmaceuticals, 5941 Optical Court, San Jose, California, 95138, USA. truongv@aridispharma.com.
Aridis Pharmaceuticals (United States) · USSRI International · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe goal of this research is to develop stable formulations for live attenuated influenza vaccines (LAIV) by employing the drying methods freeze drying, spray drying, and foam drying.

methodsFormulated live attenuated Type-A H1N1 and B-strain influenza vaccines with a variety of excipient combinations were dried using one of the three drying methods. Process and storage stability at 4, 25 and 37°C of the LAIV in these formulations was monitored using a TCID50 potency assay. Their immunogenicity was also evaluated in a ferret model.

resultsThe thermal stability of H1N1 vaccine was significantly enhanced through application of unique formulation combinations and drying processes. Foam dried formulations were as much as an order of magnitude more stable than either spray dried or freeze dried formulations, while exhibiting low process loss and full retention of immunogenicity. Based on long-term stability data, foam dried formulations exhibited a shelf life at 4, 25 and 37°C of >2, 1.5 years and 4.5 months, respectively. Foam dried LAIV Type-B manufactured using the same formulation and process parameters as H1N1 were imparted with a similar level of stability.

conclusionFoam drying processing methods with appropriate selection of formulation components can produce an order of magnitude improvement in LAIV stability over other drying methods.

Indexed as

AnimalsBetainfluenzavirusCell LineDesiccationDogsDrug StabilityExcipientsFemaleFerretsFreeze DryingHumansInfluenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesOrthomyxoviridae InfectionsVaccines, AttenuatedExcipientsInfluenza VaccinesVaccines, AttenuatedAttenuatedDryingInfluenzaStabilityVaccine

Identifiers

PMID26818839
OpenAlexW2258670756

What OpenQuestion holds

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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.