Genentech, Inc.

Boehringer Ingelheim International Gmbh

Robert L Fahrner

Jonathan Coffman

Raquel Orozco

Jeffrey Richard Salm

Marcus Andre Fiadeiro

Paul J McDonald

Jill Ann Kublbeck

Rhona O'Leary

Amy Laverdiere

Paul J Mcdonald

Robert D Van Reis

Philip M Lester

David Reifsnyder

Scott Godfrey

Jayme Franklin

Robert Van Reis

Jeffrey R Gorrell

Benedicte Andree Lebreton

Corazon Victa

Robert E Kottmeier

Joseph K McLaughlin

Deborah Follman

David Peng

Kathlyn Pham Lazzareschi

Timothy N Breece

Vikram Sisodiya

Thanmaya Peram

Rhona M O'Leary

Benedicte Lebreton

Rhona M O'leary

Integrated systems and methods for the manufacturing of recombinant proteins in mammalian cells are provided. The systems and methods include a single-use bioreactor (SUB), a tangential flow filtration system, a column chromatography skid, a tankless hold, a virus inactivation plug flow reactor, and pumps.

Integrated and continuous recombinant protein manufacturing

Methods for continuously inactivating a virus during manufacture of a protein are provided. Steps include (1) combining, at a single predetermined volumetric ratio, a composition including the protein, and a composition including a virus-inactivation reagent, to obtain a treatment composition having a predetermined property for inactivation of a virus; (2) transferring the treatment composition to a treatment vessel; (3) incubating the treatment composition in the treatment vessel at predetermined conditions; and (4) subjecting the treatment composition to a post-treatment processing operation. The single predetermined volumetric ratio has been selected to ensure that the predetermined property of the treatment composition is maintained across a range of concentrations predicted for the protein in the composition including the protein. Steps (1) to (3) are carried out (a) continuously and (b) without feedback control being exerted by either adjustment of the volumetric ratio or diversion of the treatment composition.

Methods for continuously inactivating a virus during manufacture of a protein

Methods are presented for isolating and purifying proteins by adding a polyelectrolyte to a cell culture fluid, such as a harvested cell culture fluid, and precipitating a protein-polyelectrolyte complex or a complex of impurities and the polyelectrolyte.

Polyelectrolyte precipitation and purification of proteins

A method for reducing leaching of protein A during protein A affinity chromatography is described which involves reducing temperature or pH of, or by adding one or more protease inhibitors to, a composition that is subjected to protein A affinity chromatography.

Reducing protein A leaching during protein A affinity chromatography

The present invention relates to a method for protein purification that involves the combination of non-affinity chromatography with HPTFF.

Non-affinity purification of proteins

A method for purifying proteins by Protein A chromatography is described which comprises removing contaminants by washing the solid phase with various intermediate wash buffers.

Protein purification

A process for purifying molecules from contaminants is provided. In this process a mixture containing the molecule (peptide, polypeptide, or biologically active non-peptidyl compound) and its contaminants is loaded onto a reversed-phase liquid chromatography column and the molecule is eluted from the column with a buffer containing hexylene glycol.

Purification of molecules

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San Mateo, CA, United States of America

Robert L Fahrner