Evidence map›Paper›PMID 39085576›Full record

ArticleDrug delivery and translational research2025

Dry powder formulations of hyperimmune serum.

Annalisa Bianchera, Gaetano Donofrio, Fabio Sonvico, Ruggero Bettini

Abstract read
In one paragraph

Article in Drug delivery and translational research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

4 authors.

Annalisa BiancheraDepartment of Food and Drug Sciences, University of Parma, Parco Area Delle Scienze 27/a, 43124, Parma, Italy.ORCID 0000-0002-3160-9586
Gaetano DonofrioInterdepartmental Research Centre for the Innovation of Health Products, University of Parma, Parco Area Delle Scienze, Biopharmanet-TecPadiglione 33, 43124, Parma, Italy.ORCID 0000-0002-8984-0377
Fabio SonvicoDepartment of Food and Drug Sciences, University of Parma, Parco Area Delle Scienze 27/a, 43124, Parma, Italy.ORCID 0000-0001-7372-1456
Ruggero BettiniDepartment of Food and Drug Sciences, University of Parma, Parco Area Delle Scienze 27/a, 43124, Parma, Italy. ruggero.bettini@unipr.it.ORCID 0000-0002-3857-7476

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Effective strategies against the spread of respiratory viruses are needed, as tragically demonstrated during the COVID-19 pandemic. Apart from vaccines, other preventive or protective measures are necessary: one promising strategy involves the nasal delivery of preventive or protective agents, targeting the site of initial infection. Harnessing the immune system's ability to produce specific antibodies, a hyperimmune serum, collected from an individual vaccinated against SARS-CoV-2, was formulated as a dry powder for nasal administration. The selection of adequate excipients and process are key to maintaining protein stability and modulating the aerodynamic properties of the powders for reaching the desired respiratory regions. To this end, a hyperimmune serum was formulated with trehalose and mannitol as bulking agents during spray drying, then the ability of the redissolved immunoglobulins to bind Spike protein was verified by ELISA; foetal bovine serum was formulated in the same conditions as a reference. Moreover, a seroneutralization assay against SARS-CoV-2 pseudoviruses generated from different variants of concern was performed. The neutralizing ability of the serum was slightly reduced with respect to the starting serum when trehalose was used as a bulking agent. The powders were loaded in hypromellose capsules and aerosolized employing a nasal insufflator in an in vitro model of the nasal cavity connected to a Next Generation Impactor. The analysis of the powder distribution confirmed that all powders were inhalable and could target, at the same time, the upper and the lower airways. This is a preliminary proof-of-concept that this approach can constitute an effective strategy to provide broad coverage and protection against SARS-CoV-2, and in general against viruses affecting the airway. According to blood availability from donors, pools of hyperimmune sera could be rapidly formulated and administered, providing a simultaneous and timely neutralization of emerging viral variants.

Indexed as

Antibodies, ViralCOVID-19SARS-CoV-2Administration, IntranasalAnimalsAntibodies, NeutralizingCOVID-19 SerotherapyDrug CompoundingExcipientsHumansMannitolPowdersSpike Glycoprotein, CoronavirusTrehaloseAntibodies, NeutralizingAntibodies, ViralExcipientsMannitolPowdersSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2TrehaloseHyperimmune serumImmunoglobulins formulationInhalable powdersProphylaxisViral neutralization

Identifiers

PMID39085576
PMCPMC11870897

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Registered trials

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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.