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

Patent metadata

Field	Value
Publication number	US-12209257-B2
Application number	US-201917283286-A
Country	US
Kind code	B2
Filing date	Oct 2, 2019
Priority date	Oct 8, 2018
Publication date	Jan 28, 2025
Grant date	Jan 28, 2025

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.

First claim

The invention claimed is:

1. 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 value;

wherein:
designing the actual reactor comprises at least one of (i)-(v): (i) scaling dimensions of the experimental reactor to the actual reactor having a same aspect ratio as the experimental reactor, but a different internal diameter; (ii) scaling the dimensions of the experimental reactor to the actual reactor having a same aspect ratio and a same internal diameter as the experimental reactor; (iii) scaling the dimensions of the experimental reactor to the actual reactor having a different aspect ratio than the experimental reactor and a different diameter than the experimental reactor; (iv) scaling the dimensions of the experimental reactor to the actual reactor having a different aspect ratio as the experimental reactor, but a same diameter as the experimental reactor;
wherein when designing the actual reactor comprises scaling the dimensions of the experimental reactor to the actual reactor having the same aspect ratio as the experimental reactor, the method:
(i) requires derivation of height equivalent of a theoretical plate (“HETP”), reactor volume, and internal diameter based on average flow velocity, utilizing equations (1a)-(1g) below:

HETP
=

σ

t
⁢
i
⁢
m
⁢
e

2

*
L

T
Ave
2

(

1
⁢
a

)

(1b) HETP=f(v)=(av 3 +bv 2 +cv+d), wherein a, b, c, and d are based on empirical data fits for all Dean numbers

L
=

1
2

*

(

2
⁢
5
⁢

f
⁡
(
v
)

2

±

5
*

2
⁢
5
⁢

f
⁡
(
v
)

4

+

4
⁢

f
⁡
(
v
)

2

⁢
T
⁢
min
*
v

+

2
*
T
⁢
min
*
v

)

(

1
⁢
c

)

A
=

∏

r
2

=

∏

(

i
.
d
.

Assignees

• Boehringer Ingelheim Int

Inventors

• Brown Matthew R
• Coffman jonathan
• Orozco Raquel

Classifications

• C12N2795/14261

  Methods of inactivation or attenuation · CPC title

• B01L2400/0406

  capillary forces · CPC title

• B01L2300/0883

  Serpentine channels · CPC title

• B01L2300/0627

  Sensor or part of a sensor is integrated · CPC title

• B01L2200/0647

  Handling flowable solids, e.g. microscopic beads, cells, particles · CPC title