Application of Tangential Flow-Filtration (TFF) to Enable Solvent Exchange and Precipitation Process for the Production of Payload-linkers of ADCs
Tangential Flow Filtration (TFF) is widely used in bioprocessing, including the manufacturing of mAb, ADC, etc.
We demonstrate that TFF can also be applied for the enrichment of payload-linker products after prep-HPLC purification, leading to significant volume reduction of desired fractions, shortened production time and lower solvent usage.
The application allows solvents and impurities of small molecular weight to pass through the membrane, while retaining and concentrating the payload-linker product in the retentate. This enables subsequent precipitation of the payload-linker, eliminating the need for time-consuming lyophilization. The process has been validated under GMP conditions at a production scale of 1-2 kg.