Purification Processes & UF/DF
Prepare your biologic for advancement with downstream ultra filtration (UF) and diafiltration (DF) purification processes. Whether your project requires a one-off buffer exchange to support early-stage formulation development or a full-scale process development endeavor intended for transfer to GMP facilities, our team prepares your manufacturing and fill finish processes to optimize your drug product formulation.
Purification Process Development
Our scientists develop formulations and UF/DF processes in a parallel and iterative manner. Once both are established, we characterize the processes for both bulk formulation and final dosage form manufacturing to support scale up and robustness. Additionally, your manufactured materials are tested for release and long-term stability within our central GMP laboratory to support clinical trials and commercialization. Our analytical methods, which are optimized and validated at the stage-appropriate time, further facilitate biopharmaceutical formulation development and GMP testing activities.
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts add power to your project.