Pellicon® Capsules For Ultrafiltration/Diafiltration In The Antibody Drug Conjugate Manufacturing Process

Tangential flow filtration (TFF) is essential in the manufacturing of antibody drug conjugates (ADCs). Ultrafiltration (UF) is used to concentrate the protein product and diafiltration (DF) to exchange buffer and/or remove process-related impurities from the ADC solution, including residual linker, organic solvent, and/or free drug. Clearance of organic solvent is required when processing the ADC solution directly after conjugation, for which the TFF filter must be solvent-compatible. ADC manufacturing also requires a containment strategy during post-conjugation TFF steps to protect operators from health risks associated with exposure to the highly potent ADC molecule and free drug, all while preventing contamination of the product and the environment. As a result, single-use TFF devices are a natural choice for UF/DF operations in ADC manufacturing.

In this application note we review a single-use TFF device that increases operator safety, and also saves time for improved batch turnaround and flexibility in the ADC manufacturing plant.