Genzyme Corporation

Michael Coolbaugh

Tarl Vetter

Konstantin Konstantinov

Veena Warikoo

Kevin Brower

Chad Varner

Jason Walther

Xhorxhi Gjoka

Systems and devices for producing biological products and methods of using the same are provided. An example universal skid includes a rigid support and a plurality of flow-channel hardware sets. Each flow-channel hardware set couples with a respective flow channel of a plurality of flow channels for unit operations. The flow-channel hardware sets allow the flow channels to operate in parallel or in series for continuous processing over the unit operations. An example modular assembly includes one or more single-use kits for one or more unit operations and a universal skid coupled with the one or more single-use kits. An example manufacturing system includes multiple modular assemblies coupled with each other allowing continuous processing within each modular assembly, in between the modular assemblies, fully continuous processing across multiple unit operations.

Systems and devices for producing biological products and methods of using the same

The present disclosure relates to methods and systems for the continuous production of recombinant proteins. In particular embodiments, the disclosure relates to methods and systems using capture chromatography, post-capture chromatography, virus filtration, and ultrafiltration/diafiltration for the continuous production of recombinant proteins.

Continuous production of recombinant proteins

Provided herein are methods of processing a fluid that include the use of one or both of a circuit system including a tangential flow filtration (TFF) unit and a circuit system including a tangential flow virus filtration (TFVF) unit. Also provided are integrated and continuous processes for manufacturing a therapeutic protein drug substance that include a step of processing a fluid including the recombinant therapeutic protein using any of the methods provided herein.

Methods of processing a fluid including a recombinant therapeutic protein and use thereof

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Bridgewater, NJ, United States of America

Michael Coolbaugh