Evidence map›Paper›PMID 42653647›Full record

ArticlePharmaceuticals (Basel, Switzerland)2026

Qualification and Implementation of a Robust Multi-Attribute Method Platform Across Multiple Laboratories for High-Resolution Process Characterization of Biopharmaceutical Products.

François Griaud, Patrick Sascha Merkle, Joachim Ritter, Victor Le-Minh, Haiyan Zhang, Maja Semanjski Curkovic, Stefan Mittermayr, Eva Kranjc, Nina Pirher, Jens Pettelkau and 12 more

Abstract read
In one paragraph

Article in Pharmaceuticals (Basel, Switzerland), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

22 authors.

François GriaudTechnical Research & Development (TRD) Biologics Analytical Characterization, Novartis Pharma AG, 4002 Basel, Switzerland.ORCID 0000-0002-2803-8102
Patrick Sascha MerkleTechnical Research & Development (TRD) Biologics Analytical Characterization, Novartis Pharma AG, 4002 Basel, Switzerland.
Joachim RitterTRD Biologics Drug Substance Development, Novartis Pharma AG, 4002 Basel, Switzerland.
Victor Le-MinhTechnical Research & Development (TRD) Biologics Analytical Characterization, Novartis Pharma AG, 4002 Basel, Switzerland.
Haiyan ZhangTechnical Research & Development (TRD) Biologics Analytical Characterization, Novartis Pharma AG, 4002 Basel, Switzerland.
Maja Semanjski CurkovicTRD Biologics Process Analytical Sciences, Novartis Pharmaceutical Manufacturing LLC, 1234 Mengeš, Slovenia.
Stefan MittermayrTRD Biologics Analytical Characterization, Novartis Pharma, 6250 Kundl, Austria.ORCID 0000-0001-8950-0156
Eva KranjcTRD Biologics Process Analytical Sciences, Novartis Pharmaceutical Manufacturing LLC, 1234 Mengeš, Slovenia.ORCID 0000-0002-9141-3964
Nina PirherTRD Biologics Process Analytical Sciences, Novartis Pharmaceutical Manufacturing LLC, 1234 Mengeš, Slovenia.
Jens PettelkauTRD Biologics Analytical Characterization, Novartis Pharma, 6250 Kundl, Austria.
Markus Nienhaus-StepathGenedata GmbH, 80339 Munich, Germany.
Dominik MertensGenedata AG, 4051 Basel, Switzerland.
Guillaume ReyTRD Biologics Process Analytical Sciences, Novartis Pharma AG, 4002 Basel, Switzerland.
Jérôme DayerTechnical Research & Development (TRD) Biologics Analytical Characterization, Novartis Pharma AG, 4002 Basel, Switzerland.
Manuel LangTechnical Research & Development (TRD) Biologics Analytical Characterization, Novartis Pharma AG, 4002 Basel, Switzerland.
Joanna HajdukTechnical Research & Development (TRD) Biologics Analytical Characterization, Novartis Pharma AG, 4002 Basel, Switzerland.
Camille JennyTechnical Research & Development (TRD) Biologics Analytical Characterization, Novartis Pharma AG, 4002 Basel, Switzerland.
Michel StarckTRD Biologics Process Analytical Sciences, Novartis Pharma AG, 4002 Basel, Switzerland.
Thomas JamnikTRD Biologics Process Analytical Sciences, Novartis Pharma AG, 106336 Schaftenau, Austria.
Lukas DotzauerTRD Biologics Analytical Characterization, Novartis Pharma AG, 82041 Oberhaching, Germany.
Dariusz JaneckiTRD Biologics Analytical Characterization, Novartis Pharma AG, 82041 Oberhaching, Germany.ORCID 0009-0004-6305-5372
Thomas PohlTechnical Research & Development (TRD) Biologics Analytical Characterization, Novartis Pharma AG, 4002 Basel, Switzerland.ORCID 0009-0002-7454-8186

Funding

Novartis Pharma AG
6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Indexed as

critical process parametercritical quality attributedesign of experimentsMAMmass spectrometrymulti-attribute methodprocess characterizationquality target product profile

Identifiers

PMID42653647
PMCPMC13516420

What OpenQuestion holds

Textmetadata
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.