AI Article Synopsis
- Process control is crucial in protein therapeutic manufacturing to ensure safety and efficacy for patients.
- This study focuses on the pink color variation in monoclonal antibodies and Fc-fusion proteins, identifying its cause as the association with hydroxocobalamin (OH-Cbl), a form of vitamin B12.
- A new assay was developed to measure B12 levels in proteins, helping to understand and manage color variability in manufacturing by distinguishing between hydroxocobalamin and cyanocobalamin.
Article Abstract
Process control of protein therapeutic manufacturing is central to ensuring the product is both safe and efficacious for patients. In this work, we investigate the cause of pink color variability in development lots of monoclonal antibody (mAb) and Fc-fusion proteins. Results show pink-colored product generated during manufacturing is due to association of hydroxocobalamin (OH-Cbl), a form of vitamin B12. OH-Cbl is not part of the product manufacturing process; however we found cyanocobalamin (CN-Cbl) in cell culture media converts to OH-Cbl in the presence of light. OH-Cbl can be released from mAb and Fc-fusion proteins by conversion with potassium cyanide to CN-Cbl, which does not bind. By exploiting the differential binding of CN-Cbl and OH-Cbl, we developed a rapid and specific assay to accurately measure B12 levels in purified protein. Analysis of multiple products and lots using this technique gives insight into color variability during manufacturing.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3896611 | PMC |
| http://dx.doi.org/10.4161/mabs.25921 | DOI Listing |
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