Genzyme Corporation

Tarl Vetter

Kevin Brower

Michael Coolbaugh

Konstantin Konstantinov

Veena Warikoo

Chad Varner

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

Viral filters include a filter member featuring a first surface and a second surface and having a thickness extending between the first and second surfaces in a first direction, and a plurality of channels formed in the filter member, each of the channels having a channel axis, where during use, a solution carrying a viral load flows in a direction parallel to the first surface, and at least a portion of the viral load enters the membrane through the first surface and propagates in the first direction, and where for at least 50% of the channels in the filter member, the channel axis is oriented at an angle of between 5 degrees and 85 degrees relative to the first direction.

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Framingham, MA, United States of America

Tarl Vetter