During the process development, a hydrophobic variant was identified during purification using RP-HPLC (Reversed Phase High-Performance Liquid Chromatography). Mass spectrometry (MS) analysis revealed this variant was a mAb with an incomplete leader sequence on the heavy chain. 4.3. Control Strategy Implementation
This case study demonstrates:
The target molecule exhibited a pI (isoelectric point) around 9.3, indicating a relatively basic molecule that influences purification strategy. A Mab A Case Study In Bioprocess Development