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.
The Pellicon® Capsule with Ultracel® membrane is ideal for single-use processing of ADCs. It enhances operator safety and offers organic solvent compatibility, all while providing high UF/DF performance. The Pellicon® Capsule is self-contained, gamma sterilized, and preservative-free. With these user-friendly features, the capsule is quickly and safely installed, used and removed, increasing plant productivity and reducing operator exposure to cytotoxic chemicals and aggressive solvents commonly used in the ADC manufacturing process. The Application Note provides guidance on the use of the Pellicon® Capsule for UF/DF of ADCs to assist you with your process needs.