Evidence map›Paper›PMID 37466834›Full record

ArticleDrugs in R&D2023

Biochemical Characterization of a New 10% IVIG Preparation [IgG Next Generation (BT595)/Yimmugo

Christian Duellberg, Achim Hannappel, Steffen Kistner, Oliver Maneg

Open access · goldAbstract read
In one paragraph

Article in Drugs in R&D, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 23% 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

6 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
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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

4 authors at 1 institution in 1 country.

Christian DuellbergBiotest AG, Landsteinerstr.5, Dreieich, Germany. christian.duellberg@biotest.com.ORCID http://orcid.org/0000-0001-6335-9748
Achim HannappelBiotest AG, Landsteinerstr.5, Dreieich, Germany.
Steffen KistnerBiotest AG, Landsteinerstr.5, Dreieich, Germany.
Oliver ManegBiotest AG, Landsteinerstr.5, Dreieich, Germany. oliver.maneg@biotest.com.
Biotest (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveHuman plasma is used for the generation of several life-saving drugs and contains valuable antibodies from the immunoglobulin classes IgG, IgM and IgA. Purified intravenous IgG solutions (IVIGs) form the majority of plasma-derived medicine to treat patients with various forms of immunodeficiencies. In conventional IVIG manufacturing processes, immunoglobulin classes IgM and IgA are often discarded as contaminants, but these antibody classes have been proven to be effective for the treatment of acute bacterial infections. Considering the increase in demand for human plasma-derived products and the ethical value of the raw material, a more resource-saving usage of human plasma is needed. Intensive research over the last decades showed that adverse reactions to IVIGs depend on the presence of thrombogenic factors, partially unfolded proteins, non-specific activation of the complement system, and blood group specific antibodies. Therefore, new IVIG preparations with reduced risks of adverse reactions are desirable.

methodA new manufacturing process that yields two biologics was established and quality attributes of the new IVIG solution (Yimmugo

resultsHere, we provide a biochemical characterization of Yimmugo

conclusionYimmugo

Indexed as

Immunoglobulin GImmunoglobulins, IntravenousDrug CombinationsHumansImmunoglobulin AImmunoglobulin MImmunologic FactorsPlasmaDrug CombinationsImmunoglobulin AImmunoglobulin GImmunoglobulin MImmunoglobulins, IntravenousImmunologic Factorstrimodulin

Identifiers

PMID37466834
PMCPMC10439088
OpenAlexW4384665176

What OpenQuestion holds

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LicenceCC BY-NC
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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.