Genzyme Corporation

Sanofi

Kevin Brower

Marcella Yu

Rao Koduri

Huawei Qiu

Patrick Finn

Christopher Winter

Tarl Vetter

Joachim Theilhaber

Richard C Gregory

Gary Shapiro

Natalia Malkova

Parminder Mankoo

Jack R Pollard

Veena Warikoo

Feng Song Liu

Michael Coolbaugh

Chad Varner

Konstantin Konstantinov

Jason Walther

Jin Yin

Xhorxhi Gjoka

Chris Hwang

Feng Liu

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 invention provides an improved pan-TGF-β antibody for treatment of conditions that are mediated by TGF-β, including autoimmune diseases, fibrotic conditions, and cancers. Also provided are methods and uses of the antibody in conjunction with other immunomodulatory agents such as an anti-PD-1 antibody.

Anti-TGF-beta antibodies and their use

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

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.

Tangential viral filtration

The invention provides an improved pan-TGF-&#x3b2; antibody for treatment of conditions that are mediated by TGF-&#x3b2;, including autoimmune diseases, fibrotic conditions, and cancers. Also provided are methods and uses of the antibody in conjunction with other immunomodulatory agents such as an anti-PD-1 antibody.

The invention as disclosed herein provides a method for purifying a non-antibody protein from solution, comprising a chromatography step wherein the solution is passed over an affinity construct containing an affinity ligand-coupled solid support, wherein the affinity construct is associated with a bioprocess unit operation, and isolating the non-antibody protein from solution.

Affinity-based analytical purification of biotherapeutics for bioprocess monitoring

Anti-TGF-&#x3b2; antibodies and their use

Disclosed herein are methods that have been developed to control the formation of disulfide bonds between polypeptides of a multimeric protein produced by a bioprocess. Also disclosed are protein solution parameters that allow for controlling the formation of disulfide bonds. In one example, the methods disclosed herein can be used to control the proportion of half antibody molecules in an antibody solution.

Methods of controlling the formation of disulfide bonds in protein solutions

Growing community of inventors

Holliston, MA, United States of America

Kevin Brower