Lowering the pH during harvest. As the culture ages, CO2 builds up, lowering pH to 6.7. Mab-X has a unique hydrophobic patch in the Fc region that is prone to unfolding at pH <6.8.
The downstream purification process demonstrated an cumulative step yield of
A Mab’s high concentration (20 g/L intermediate) posed a challenge. Standard 20 nm filters fouled rapidly. The solution: with pre-filtration using 0.1 µm and operation at constant pressure (2 bar). Flux dropped only 30% over 4 hours, acceptable for GMP. A Mab A Case Study In Bioprocess Development
Monoclonal antibodies (mAbs) represent the largest sector of the modern biopharmaceutical industry. However, translating a therapeutic candidate from the laboratory bench to commercial-scale manufacturing is a complex engineering feat.
: Common examples include aggregation, glycosylation profiles, and host cell proteins (HCP). 2. Characterize the Process Lowering the pH during harvest
An ultra-high-capacity Protein A resin was implemented for initial product capture. Loaded at
The N-glycan profiling via hydrophilic interaction liquid chromatography (HILIC) confirmed that the structural integrity of the fragment crystallizable (Fc) region was maintained. This ensured optimal antibody-dependent cellular cytotoxicity (ADCC) effector function. 5. Summary of Results and Key Takeaways Flux dropped only 30% over 4 hours, acceptable for GMP
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Development begins with the Target Product Profile (TPP) , which outlines the desired clinical performance. The study identified key attributes that must be controlled, including: