Boehringer Ingelheim International Gmbh

Raquel Orozco

Jonathan Coffman

Robert L Fahrner

Scott Godfrey

Jeffrey Richard Salm

Marcus Andre Fiadeiro

Jill Ann Kublbeck

Jens Holger Vogel

Stephanie Parker

Jeff Goby

Natira Gnat Matthews

Matthew R Brown

Cameron Lee Bardliving

A viral inactivation device including at least one continuous viral inactivation reactor having an inlet, an outlet, and a tubular flow path. The tubular flow path includes a set of alternating turns that form a serpentine pattern between the inlet and the outlet.

Continuous flow reactor for low pH viral inactivation

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

A viral inactivation device including at least one experimental continuous viral inactivation reactor having at least an inlet, an outlet, and a tubular flow path and a computer system that, based on the experimental continuous viral inactivation reactor can design, select, make, and/or manufacture a scaled actual reactor. The tubular flow path includes a set of alternating turns that form a serpentine or an interwoven pattern between the inlet and the outlet.

System and method to determine critical process parameters for a continuous viral inactivation reactor to design and manufacture same

A continuous flow reactor having a plurality of interwoven flow paths in fluid communication to form a single continuous flow reactor tube having a single flow path.

Continuous flow reactor for viral inactivation

Methods for continuously inactivating virus during manufacture of a biological product are provided. The methods include steps of (1) combining (a) a composition including a biological product, and (b) a composition including a virus-inactivation reagent, to obtain (c) a treatment composition having a predetermined property for inactivation of a virus, (2) confirming that the treatment composition exhibits the predetermined property, (3) transferring the treatment composition to a treatment vessel that includes an inlet, an outlet, and a static mixer, the transferring occurring at the inlet, (4) incubating the treatment composition in the treatment vessel at a predetermined temperature while the treatment composition flows at a predetermined rate and contacts the static mixer, and (5) collecting the treatment composition from the treatment vessel at the outlet, wherein steps (1) to (5) are carried out continuously. Apparatuses and systems including such a treatment vessel are also provided.

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El Cerrito, CA, United States of America

Raquel Orozco