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US 2021/0388323 A1Published application
System and method to determine critical process parameters for a continuous viral inactivation reactor to design and manufacture same
AssigneeBoehringer Ingelheim International GmbH
InventorsMatthew R. BROWN, Jonathan COFFMAN, Raquel OROZCO
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Abstract
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.
Claims48
A method for designing an actual reactor for viral inactivation comprising:
- introducing a process stream, including detectable particles/tracer, into an experimental reactor having a known radius of curvature and a known internal diameter, wherein the experimental reactor is in communication with at least one of a first detector and a second detector;
- detecting a flow rate of the process stream in the experimental reactor by at least one of the first detector and the second detector;
- detecting fluid-phase parameters of the process stream by at least one of the first detector and the second detector;
- detecting the detectable particles exiting the experimental reactor by the second detector;
- determining, based on the introduced process stream including the detectable particles, empirical values relating to at least one of experimental reactor parameters and fluid-phase parameters;
- determining non-empirical values relating to at least one of the experimental reactor parameters and the fluid-phase parameters;
- and
- designing the actual reactor based on the determined empirical values and the determined non-empirical values.
5 more elements
A system to determine an actual viral inactivation reactor size comprising.
- a processor (1001);
- and
- a non-transitory machine-readable storage medium (1002) storing machine-readable instructions that are executable by the processor (1001) to:
- receive parameters of an experimental reactor (100) that is in communication with at least one of a first detector (30) and a second detector (40);
- detect a flow rate of a process stream including detectable particles in the experimental reactor (100) by at least one of the first detector (30) and the second detector (40);
- detect fluid-phase parameters of the process stream in the experimental reactor (100) by at least one of the first detector (30) and the second detector (40);
- detect, by the second detector (40), the detectable particles by detecting a first detectable particle exiting the experimental reactor (100) and a last detectable particle exiting the experimental reactor (100);
- determine empirical values (200) of at least one of reactor parameters of the experimental reactor (100) and fluid parameters of the process stream;
- determine non-empirical values (300) of at least one of the reactor parameters of the experimental reactor (100) and the fluid parameters of the process stream;
- and
- design an actual reactor (400) for an actual process stream having a predetermined volume of fluid, wherein the fluid includes substantially similar parameters as the fluid parameters in the experimental reactor (100).
8 more elements
A system for designing an actual reactor for continuously inactivating virus during manufacturing of a biological product, the system comprising:
- an experimental reactor (100) having a known radius of curvature and a known diameter and designed to receive a process stream;
- at least one of a first detector (30) and a second detector (40) in communication with the experimental reactor (100), wherein the at least one of the first detector (30) and the second detector (40) detects fluid-phase parameters of the process stream and wherein the second detector (40) detects detectable particles exiting the experimental reactor (100);
- a processor (1001);
- and
- a non-transitory machine-readable storage medium storing machine-readable instructions (1002) that are executable by the processor (1001) to:
- determine empirical values (200) corresponding to parameters of at least one of the experimental reactor (100) and fluid of the process stream;
- determine non-empirical values (300) corresponding to parameters of at least one of the experimental reactor (100) and fluid of the process stream;
- and
- based on the determined empirical values and the determined non-empirical values, design the actual reactor for an actual process stream having a predetermined volume of fluid.
6 more elements
A system for designing an actual reactor for continuously inactivating virus during manufacturing of a biological product, the system comprising:
- an experimental reactor (100) having an inlet, an outlet, and a tubular flow path comprising a set of alternating turns that form a serpentine pattern between the inlet and the outlet, wherein the serpentine pattern includes a predetermined radius of curvature and a predetermined diameter and wherein the experimental reactor (100) is designed to receive a process stream;
- at least one of a first detector (30) and a second detector (40) in communication with the experimental reactor (100), wherein the at least one of the first detector (30) and the second detector (40) detects fluid-phase parameters of the process stream and wherein the second detector (40) detects detectable particles exiting the experimental reactor (100);
- a processor (1001);
- and
- a non-transitory machine-readable storage medium storing machine-readable instructions that are executable by the processor (1001) to:
- determine empirical values (200) of at least one of experimental reactor (100) parameters and the fluid parameters of the process stream;
- determine non-empirical values (300) of at least one of the reactor parameters of the experimental reactor (100) and the fluid parameters of the process stream;
- and
- design the actual reactor based on the determined empirical values and the determined non-empirical values, wherein the actual reactor includes a serpentine pattern substantially similar to the serpentine pattern of the experimental reactor (100), but designed and configured to accommodate an actual process stream having a predetermined volume of fluid.
6 more elements
A system for designing an actual reactor for continuously inactivating virus during manufacturing of a biological product, the system comprising:
- an experimental reactor (100) having an inlet, an outlet, and at least one interwoven tubular flow path (10Z) comprising a plurality of turns that are in different, non-parallel planes;
- at least one of a first detector (30) and a second detector (40) in communication with the experimental reactor (100), wherein the at least one of the first detector (30) and the second detector (40) detects fluid-phase parameters of a process stream and wherein the second detector detects detectable particles exiting the experimental reactor (100);
- a processor (1001);
- and
- a non-transitory machine-readable storage medium storing machine-readable instructions that are executable by the processor (1001) to:
- determine empirical values (200) of at least one of experimental reactor parameters and the fluid parameters of the process stream;
- determine non-empirical values (300) of at least one of the reactor parameters of the experimental reactor (100) and the fluid parameters of the process stream;
- and
- design the actual reactor based on the determined empirical values and the determined non-empirical values, wherein the actual reactor includes an interwoven tubular flow path (10Z) substantially similar to the interwoven tubular flow path of the experimental reactor (100), but designed and configured to accommodate an actual process stream having a predetermined volume of fluid.
6 more elements
Dependencies are inferred from the claim text.