ArticleElectrophoresis2025
Towards an Analytical Procedure Control Strategy for the Capillary Zone Electrophoresis Method for Monoclonal Antibodies: Alternatives for ε-Aminocaproic Acid and Triethylenetetramine.
Article in Electrophoresis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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.
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.
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The ICH guideline Q14 on analytical procedure development underlines the importance of science and risk-based methods for the evaluation of the quality of medicines. Ultimately, a pharmaceutical company, the sponsor, is responsible that the analytical method is fit-for-purpose during routine use throughout its lifecycle. Part of the analytical procedure control strategy is the responsibility to assure availability of critical materials of the analytical method. For capillary zone electrophoresis (CZE) methods, the background electrolyte (BGE) composition is a key and critical material. In this study, we investigated whether key ingredients of the ε-aminocaproic acid (eACA) CZE (eACA-CZE) method for monoclonal antibodies can be replaced by structurally related chemicals. The complex heterogeneity patterns are compared, as well as the reportable results as the percentage main, acidic and basic peaks. Overall, the results underline the ruggedness of the eACA-CZE method and provide alternative options to eACA and triethyltetramine (TETA), in case there are quality or supply issues, thus de-risking and safeguarding release and stability studies for therapeutic mAbs.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.