ArticlePharmaceutical research2026
Differences in mAb Galactosylation Caused by the Leaching of Manganese Ions from Different Bioreactors.
Article in Pharmaceutical research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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10 authors.
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Abstract
backgroundProtein N-glycosylation is one of the critical quality attributes of monoclonal antibody (mAb). Evaluating its scalability and batch-to-batch consistency is essential for ensuring process robustness and product safety and efficacy.
resultsThis study revealed that Project A exhibited significant scale differences in galactosylation ratio during process development and scale-up, with galactosylation levels in 2 L bioreactors being significantly greater than those in shake flasks and 200 L single-use bioreactors. We investigated the cause of this phenomenon and determined that the elevated galactosylation in 2 L bioreactor was due to the leaching of 0.05 μM to 0.06 μM manganese ions from the stainless-steel components in the 2 L glass bioreactor. These scale differences can be eliminated by adding 0.2 μM MnCl
conclusionsThese findings demonstrate that metal ion leaching presents a substantial challenge to the process consistency of mAb. We have proposed a series of targeted and practical solutions to address the issue of "equipment and material leaching" during the production of mAb glycosylation amplification.
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