Methodology for assessing Repligen ProStream® and HyStream® Tangential Flow Filtration Cassettes in an Antibody-Drug-Conjugate Process

Antibody-drug conjugates (ADCs) is a growing field requiring specific handling due to the highly potent drug or highly active pharmaceutical ingredient (HAPI). The generic ADC process is composed of chemical conjugation steps followed by purification (removal of small molecules) and buffer exchange steps through Tangential Flow Filtration (TFF). In this article, we investigate the use of the ProStream® and HyStream® TFF cassettes from Repligen in comparison to reference cassettes in 1) a side-by-side comparison of a standard process and 2) in a challenging process (high load and high concentration factor). We obtained comparable process performance results (processing time and yield) and product quality attributes (including but not limited to Drug-to-Antibody Ratio (DAR), High Molecular Weight (HMW) and Low Molecular Weight (LMW) levels, residual organic solvent and free drug content) as in the reference processes. Thus, this evaluation provides encouraging results to support ProStream and HyStream cassette use in ADC processes.