ArticleBMC biotechnology2025
Utilizing non-clonal CHO cell derived materials for preclinical studies of complex molecules.
Article in BMC biotechnology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.
What it found
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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, 1 synthesis or guideline pooled it.
- Pooled it
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe use of non-clonal CHO cell derived materials for preclinical studies has been found to be a valuable approach to accelerate the development of monoclonal antibodies (mAbs) for first-in-human (FIH) studies. In a comprehensive study, we assessed the culture performance, productivity, and product quality of non-clonal cell lines compared with clonal cell lines expressing various biologic modalities to determine if this approach can be applied to complex molecules.
resultsWe evaluated a multi-specific antibody, a cytokine-Fc fusion protein, and a mAb produced using the stable pool, the pool of top clones, and the lead clone utilizing transposase-mediated integration. The results indicated that the attributes were comparable regardless of the source of cells. Building upon these findings, the study progressed to the preclinical manufacturing of two multi-specific antibodies using both the pool of top clones and the lead clone. Subsequently, clinical manufacturing of these multi-specific antibodies was performed using the lead clone. The batches produced with the pool of clones and the lead clone demonstrated a high level of comparability in culture performance, productivity, and product quality.
conclusionsIn conclusion, non-clonal CHO cell derived materials can be effectively utilized for preclinical studies of complex molecules without compromising their quality, allowing for accelerated development for FIH studies.
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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.