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Methods for manufacturing adjuvant

A technology of body adjuvant and solvent, applied in the field of manufacturing adjuvant containing saponin, can solve the problem that molecular pathway is not clearly defined, etc.

Pending Publication Date: 2020-04-17
GLAXOSMITHKLINE BIOLOGICALS SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although QS-21 has been shown to activate the ASC-NLRP3 inflammasome and subsequent IL-1β / IL-18 release (Marty-Roix, R. et al., 2016), the exact molecular pathways involved in the adjuvant effects of saponins have not been clarified ground definition

Method used

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  • Methods for manufacturing adjuvant
  • Methods for manufacturing adjuvant
  • Methods for manufacturing adjuvant

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0451] Embodiment 1: the research of the first solution preparation method and composition

Embodiment 1A

[0452] Example 1A - Solvent Composition

[0453] method

[0454] To study the effect of solvent composition on liposome production, solutions of DOPC, cholesterol and 3D-MPL were prepared at various ethanol / isopropanol ratios.

[0455] Each of DOPC, cholesterol and 3D-MPL was separately dissolved at 55° C. (60% by volume for DOPC, 20% for cholesterol, and 20% for 3D-MPL) for 15 minutes. The 3D-MPL solution was then added to the DOPC solution and this mixture was added to the cholesterol solution and mixed for a further 15 minutes to provide a final composition with 150 mg / ml DOPC (20:5:1 weight ratio DOPC :cholesterol:3D-MPL).

[0456] The single-chamber microfluidic device was operated at a total flow rate of 14 ml / min, a flow rate ratio of 20 (19:1) (1:19 organic phase:aqueous phase), using water for injection as the aqueous phase stock solution, and an environment at room temperature .

[0457] result

[0458] Table 1 – Effect of solvent composition on liposome...

Embodiment 1B

[0463] Example 1B - Solution Preparation

[0464] method

[0465] Evaluates the order in which components are added, which compares the two following methods:

[0466] 1. Separately dissolve DOPC, cholesterol and 3D-MPL (60%, 20%, 20% by volume) in 80:20 ethanol:IPA for 15 minutes at 55°C. The 3D-MPL solution was then added to the DOPC solution and further mixed for another 15 minutes. The 3D-MPL / DOPC mixture was then added to the cholesterol solution and mixed for a further 1 hour to provide a final composition with 120 mg / ml DOPC (20:5:1 weight ratio DOPC:cholesterol:3D-MPL).

[0467] 2. Suspend 3D-MPL with 50% solvent (80:20 ethanol:IPA), and then add to DOPC and cholesterol powder. The volume was then adjusted with the remainder of the solvent, and the mixture was heated to 40°C for 15 minutes to provide a final composition with 120 mg / ml DOPC (20:5:1 weight ratio DOPC:cholesterol:3D-MPL).

[0468] Method 1 requires keeping the mixture at 55°C for 1 hour for comp...

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Abstract

The present invention relates to compositions and methods for manufacturing an adjuvant comprising a saponin using a microfluidic device and to aspects thereof.

Description

technical field [0001] The present invention relates to methods and related aspects for the manufacture of saponin-containing adjuvants using microfluidic devices. [0002] Background of the invention [0003] Adjuvants are included in vaccines to improve humoral and cellular immune responses, especially in the case of low immunogenic subunit vaccines. Similar to natural infection by pathogens, adjuvants rely on activation of the innate immune system to promote long-lasting adaptive immunity. As simultaneous activation of multiple innate immune pathways is a hallmark of natural infection, adjuvants can combine multiple immune stimulants to promote adaptive immune responses to vaccination. [0004] Adjuvant System 01 (AS01) is a liposome-based adjuvant that contains two immunostimulants, 3- O - Deacylated-4'-monophosphoryl lipid A (3D-MPL) and QS-21 (Garcon and Van Mechelen, 2011; Didierlaurent et al., 2017). The TLR4 agonist 3D-MPL was obtained from Salmonella minnesota ( ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/39A61K9/127A61K8/55A61K8/14
CPCA61K39/39A61K2039/55555A61K2039/55572A61K2039/55577B01F33/3017Y02A50/30B01F23/41B01F25/4334B01J19/0093B01L3/502769B01F2215/0431B01F2215/044B01F2215/045B01F23/4105B01F23/4143B01F2101/22
Inventor P.阿尔旺P.耶乌莱L.勒古里雷D.西法卡基斯L.斯特罗迪奥
Owner GLAXOSMITHKLINE BIOLOGICALS SA
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