Antibody-drug conjugates (ADCs) are emerging as an important class of biopharmaceuticals, particularly for the treatment of cancer. These conjugated monoclonal antibodies (mAbs) have the potential to deliver cytotoxic payloads directly to the targeted tumor cells. The manufacturing of ADCs poses several challenges. ADC molecules may exhibit different biophysical properties than their unconjugated mAb counterparts, such as a difference in aggregation propensity, thermal stability, and enhanced sensitivities to chemical and physical stress during manufacturing. These factors are important to consider when developing the manufacturing process for ADCs.<br/><br/>Tangential flow filtration (TFF) is an integral part of the ADC manufacturing process. Generally, there are at least two ultrafiltration-diafiltration (UFDF) steps in the ADC conjugation process. Understanding the flux behavior of ADC molecules and how they might differ from mAb molecules is critical for developing a robust process step and achieving high product quality. In addition, the effect of shear and cavitation on ADC product quality must be understood. In this presentation, we will discuss the impact of TFF operating parameters on ADCs and their mAb intermediates and the potential effects of physical stresses, such as shear and cavitation on product quality.

Effect of tangential flow filtration process parameters on antibody-drug conjugates

2019 Spring National Meeting

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