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Biologics Purification & UF/DF

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.

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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.

Uf/df Process Development

Tangential Flow Filtration (TFF) Processing
Protein Purification
Tangential Flow Filtration (TFF) Processing

TFF process development is critical to determine compatible membranes and process conditions as well as ensure your platform is scalable to produce biotherapeutics in suitable yield and quality. Our development endeavors focus on a scalable process to define optimal conditions for TFF, including the optimization of transmembrane pressure (TMP), feed flowrate, permeate flux, buffer compositions, therapeutic concentration, exchanged diavolumes and surfactant addition.

Protein Purification

Our team optimizes downstream material purification processing for development and characterization endeavors. We have the capabilities to purify proteins across a broad range of separation modes, including Protein A, SEC, IEX, and HIC.

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.