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Optimal placement of a robust solvent/detergent process post viral ultrafiltration of an immune gamma globulin

A technology of immunoglobulin and non-ionic detergent, which is applied in the direction of immunoglobulin, virus/bacteriophage, virus, etc., and can solve problems such as destruction and protein denaturation

Inactive Publication Date: 2006-07-05
ORTHO-CLINICAL DIAGNOSTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The S / D method remains the better virus inactivation method for blood product purification; other more invasive and destructive techniques include the use of aldehydes and ultraviolet light, which have been shown to excessively denature or destroy proteins

Method used

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  • Optimal placement of a robust solvent/detergent process post viral ultrafiltration of an immune gamma globulin
  • Optimal placement of a robust solvent/detergent process post viral ultrafiltration of an immune gamma globulin
  • Optimal placement of a robust solvent/detergent process post viral ultrafiltration of an immune gamma globulin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0174] Virus-depleted RhoGAM was prepared by ultrafiltration as described in U.S. Patent No. 6,096,872  , with the following improvements:

[0175] 6.802 Kg of Rho(D) immunoglobulin purified to step "Pellet II Slurry" by the modified Cohn purification method was resuspended in 20.406 L of Water for Injection (WFI), U.S.P., and cooled to 4°C. The mixture was vortexed (no foaming) for 4 hours and stored at 4°C until use.

[0176] After the SIP procedure, a Viresolve-180R module (Millipore Corporation) (20 stacks) for a volume of pellet II resuspended in a volume of approximately 27.208 L was installed. The Pellicon CIP / SIP module was replaced with 2 Biomax-50 cassettes installed. Viresolve-180 modules were chlorinated and cleaned as described above. The Biomax-50 membrane was rinsed with WFI, U.S.P. Benzalkonium chloride (Roccal) was measured on the last permeated rinse sample; the benzalkonium chloride content was 8 ppm. Diffusion tests were performed on Biomax-50 cartrid...

Embodiment 1A

[0216] The 150 mM NaCl-glycine buffer used in Example 1 was prepared as follows:

[0217] Calculate the appropriate buffer volume to prepare as follows:

[0218] [Resuspended slurry volume (L)×10L]×2+60=approximate buffer volume to be prepared

[0219] [27.208L×10L]×2+60=604.16L buffer to be prepared

[0220] Determine and measure the amount of material needed to add to a calibrated depyrogenated container:

[0221] Material

required concentration

×Batch size

= required amount

NaCl

Glycine

Polysorbate 80

8.87g / L

15.01g / L

0.02g / L

604.16L

604.16L

604.16L

5,358.90g

9,068.44g

12.08g

[0222] Rinse the weighed Polysorbate container several times with a total of approximately 2 L of Water for Injection, U.S.P., adding an aliquot of each wash to the volume of each batch to make up to 604 L. Determine the quantities of the following materials:

[0223] Material

required concentrat...

Embodiment 2

[0228] Using S / D and sorbent in RhoGAM  virus inactivation in

[0229] UF Feasibility Study

[0230] Materials and methods

[0231] squeeze-D immunoglobulin

[0232] Human immunoglobulins are obtained by a fully modified Cohn-Oncley fractionation method, (see U.S. Patent No. 6,096,872, and Examples 1 and 1A herein), followed by nanofiltration using a Viresolve 180 size exclusion filter to prepare RhoGAM  Ultra-Filtered Rh(D) Immunoglobulin (Human), (Ortho-Clinical Diagnostics, Raritan, NJ). The material is stored under sterile conditions at 2°C-8°C until use.

[0233] Preparation of virus

[0234] Viruses were prepared as titered stock cultures prior to spiking into immunoglobulins. Stocks of bovine viral diarrhea virus (BVDV), pseudorabies virus (PRV), and West Nile virus (WNV) (strain NIAID V-554-110-522, ATCC, Manassas, VA) were prepared according to industry standard procedures. with cultures.

[0235] TCID on samples collected by the Orho Clinical-Diagnosti...

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PUM

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Abstract

The solvent-detergent (S / D) process is used to inactivate enveloped viruses in plasma products. While concentrations of 1.0% detergent and 0.3% tri-n-butyl phosphate solvent have been considered necessary for robust removal of viral activity, we show the effectiveness of solvent-detergent treatment after fractionation and nanofiltration of an immune gamma globulin preparation, which required significantly reduced concentrations of solvent and detergent. Reduced levels of solvent and detergent lead to greater efficiencies in their removal post-inactivation with the potential for greater yields and decreased processing costs.

Description

Background of the invention [0001] The present invention relates to the field of virus inactivation using solvent / detergent methods in blood products and blood product compositions comprising blood, blood components, plasma or any fraction thereof containing blood proteins , concentrates or derivatives, plasma-containing products and plasma-fraction-containing products containing labile proteins, such as immunoglobulins. Solvents used include, in particular, dialkyl and trialkyl phosphates, and detergents include partial esters of sorbitan hydrides, including oxyethylenated alkylphenols and in particular Tritons  . Thus, the blood product and blood product compositions are purified by rendering the blood product substantially free of enveloped viruses such as hepatitis viruses and other viral infectivity. [0002] The solvent-detergent (S / D) method has been used for nearly 20 years to inactivate enveloped viruses in plasma products; it remains the method of virus inactivati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12N7/06
CPCC12N2770/24163C12N2710/16763A61L2/0088C07K16/065A61L2/0017C12N7/00A61L2/0011C12N2770/24363A61P43/00C12N7/04
Inventor R·W·范霍尔滕S·M·奥滕里思
Owner ORTHO-CLINICAL DIAGNOSTICS
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