ReviewBioengineering & translational medicine2026
Current GMP standards for the large-scale production of monoclonal antibodies.
Review in Bioengineering & translational medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Monoclonal antibodies have revolutionized modern medicine due to their target-specific properties and effectiveness in treating a wide range of diseases, including cancer, autoimmune disorders, infectious diseases, and neurological conditions. Importantly, their large-scale production for human use requires strict adherence to good manufacturing practice (GMP) standards to ensure quality, safety, and efficacy. This article reviews key aspects of monoclonal antibody production under GMP standards, from cell-line selection to culture strategies, antibody purification, formulation, and quality control processes. Additionally, we discuss the significance of validation and traceability in production, as well as the implementation of emerging technologies to enhance manufacturing efficiency and safety. Despite progress in bioprocesses and regulatory frameworks, several challenges, such as batch-to-batch variability, high production costs, and the need to continuously adapt processes to new regulations, remain to be solved. The integration of innovative approaches with evolving regulations will enable the optimization of monoclonal antibody production and ensure their global accessibility.
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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 Socratic graph.