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A client’s Mab manufacturing process was transferred in and need to be scaled up for the 1st time.
During the Engineering run, a high level of disulfide bone reduction was found in the Drug Substance (DS) and DSP intermediates.
The bench-scale study was performed to investigate harvest pool storage conditions impact on the disulfide bond reduction.
By implementing the optimized harvest operation, pool storage condition and subsequent DSP operations, the disulfide bond reduction issue was resolved with DS Low Molecular Weight controlled well within specification.
SEC and NR-CE results of DS from the improved process