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

A virus inactivation and reactor technology, applied in sterilization methods, chemical instruments and methods, biochemical equipment and methods, etc., can solve problems such as low efficiency and time-consuming

Pending Publication Date: 2021-07-23
BOEHRINGER INGELHEIM INT GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This trial and error approach is inefficient and time consuming

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0206] The dwell time distribution is generated.

[0207] The JIB was designed based on a previous development project by Boehringer Ingelheim and 3D printed by 3D Systems (Rock Hill, SC) using SLA technology. Riboflavin and glucose used to create mobile phases and pulse tracers were purchased through Thermo Fisher Scientific (Suwanee, GA). The viscosity of the solution was determined by a microVISC S viscometer using an A05 chip (SanRamon, CA). The density of the solution was determined with a Mettler-Toledo Densito density meter (Columbus, OH).

[0208] A mid-sized 3D printed JIB was tested using an Akta Avant 150, while a large JIB was tested using an Akta Pilot 600 from GE Healthcare (Uppsala, Sweden). The JIB was first flushed with 1 reactor volume of mobile phase. Next, a fixed volume of riboflavin dissolved in the mobile phase is pulsed and expelled with the mobile phase. This yielded a residence time distribution (RTD) profile upon exiting the reactor, detected and...

Embodiment 2

[0270] Mobile Phase and Flow Chamber.

[0271] The JIB was designed based on a previous development project, which is described in pending U.S. Patent Serial No. 62 / 742534 (herein incorporated by reference in its entirety), and was developed using SLA technology from 3D Systems (Rock Hills, SC) 3D printing. Riboflavin, Tris buffer (TSB) and glucose used to make mobile phases were purchased through ThermoFisher Scientific (Suwanee, GA). The viscosity of the solution was measured by a microVISC S viscometer (San Ramon, CA) using an A05 chip. The density of the solution is determined with a calibrated pipette and balance.

[0272] Phage selection:

[0273] ΦX174 and the corresponding host bacteria E. coli C were purchased from ATCC (ATCC catalog numbers: 13706-B1 and 13706, respectively). The concentration of ΦX174 was quantified by using a standard plaque formation assay, which required co-inoculation of the liquid and the host bacterium E. coli C on tryptic soy agar wit...

Embodiment 3

[0284] Determine parameters to scale up the reactor by a factor of 5

[0285] In one example, users use Figure 1C In the reactor, the number of equipment in series can be calculated (for example, if Figure 1D shown) to provide the process with a target residence time distribution. In addition, the user can leverage the work done to calculate the dimensions of a larger scale reactor. In this experiment, it was determined Figure 2A In the system shown Figure 1C Flow path inner diameter (i.d.) and radius of curvature of the reactor shown. exist Figure 2A In the system shown, determine Figure 1C The inner diameter of the flow path in the middle reactor is 0.635 cm, and the radius of curvature is 0.6825 cm. To obtain these parameters, tracer pulses were injected into Figure 1C shown in the reactor and flushed out at different flow rates. The results of these experiments are shown in Figure 2B -C. After the pulse injection experiment was completed, the resulting...

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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.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of U.S. Provisional Application No. 62 / 742,506, filed October 8, 2018, the contents of which are expressly incorporated herein by reference. technical field [0003] The present disclosure generally relates to a system and method for determining key process parameters and designing and manufacturing a continuous virus inactivation reactor. Background technique [0004] Defining the residence time of virus particles in a plug flow reactor (PFR) is currently difficult to quantify due to the hydrodynamic phenomena that occur during the flow of process streams in recirculation pipes, where the flow rate of the process stream in the center of the pipe can be Twice the average flow rate of the flow, and nearly stagnant near the pipe wall. Therefore, currently the only way to determine the correct PFR parameters for virus inactivation is through experiments. This trial-and-error approach ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12M1/12A61L2/00C07K16/00C12M1/36C12M1/00
CPCC12M23/06C12M41/48C12N7/00C12N2795/14261C12M47/16G16B40/00B01L3/502715B01L2200/0647B01L2300/0627B01L2300/0883B01L2400/0406C12M23/16C12N7/08G01N11/02
Inventor M·R·布朗J·科夫曼R·奥罗斯科
Owner BOEHRINGER INGELHEIM INT GMBH