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Viral clearance process

A technology of immunoglobulin and cut-off value, which is applied to the preparation method of peptides, chemical instruments and methods, disinfection, etc., and can solve problems that do not involve the removal of contaminating hepatitis virus particles

Inactive Publication Date: 2001-01-10
ORTHO-CLINICAL DIAGNOSTICS +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Both had some degree of success in removing contaminating proteins, however neither involved clearing contaminating hepatitis virus particles to provide a safe injectable formulation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0117] Virus-free RhoGAM(R) was produced by the following ultrafiltration method.

[0118] Rho(D) immunoglobulin 3.250 kg was purified to "Pellet II" by the modified Cohn purification method (see above), which was resuspended in 9.750 L of water for injection (WFI) U.S.P. and cooled to 5°C. The mixture was vortexed (no foaming) for 4 hours and stored at 4°C until use. The weight of the precipitate II resuspension was 3.250 kg.

[0119] After SIP, a Viresolve-180R module (Millipore Corporation) (10 stacks) suitable for approximately 13.0 L of Precipitate II resuspension was installed. The Pellicon CIP / SIP module was replaced with 2 Biomax-50 filter frames. The Viresolve-180R module is chlorine sterilized and washed. Rinse the Biomax-50 filter frame with WFI U.S.P. Benzalkonium chloride (Roccal) was assayed on the last permeated rinse sample; benzalkonium chloride concentration was 6 ppm. Diffusion tests were performed on Biomax-50 filter frames; the release rate was calcu...

Embodiment 1A

[0153] The 150 mM NaCl-glycine buffer used in Example 1 was prepared as follows:

[0154] Calculate the amount of buffer to prepare:

[0155] [Resuspension volume (L)×10L]×2+60=buffer preparation volume

[0156] [13L×10L]×2+60=prepare 320L buffer

[0157] Determine and measure the amount of raw material needed, and add to a depyrogenated container.

[0158] raw material

required concentration

× per batch

= required amount

NaCl

8.87g / L

302L

2，838.4g

Glycine

15.01g / L

320L

4，803.2g

Polysorbate 80

0.02g / L

320L

6.4g

[0159] raw material

required concentration

× per batch

= required amount

1.0N NaOH

0.125ml / L

320L

40ml

[0160] The mixture was diluted with Water for Injection, U.S.P., and the resulting mixture was mixed for 60 minutes. Measure the pH; the requirement is 6.3-6.5. The actual pH is 6.46. If not, add ...

Embodiment 2

[0164] In Example 2, virus-free RhoGAM® was produced by ultrafiltration as previously described with the following modifications:

[0165] Purify 6.802 kg of Rho(D) immunoglobulin to "precipitate II slurry" by the modified Cohn purification method, resuspend in 20.406L water for injection (WFI) U.S.P., and cool to 4°C. The mixture was vortexed (no foaming) for 4 hours and stored at 4°C until use.

[0166] After SIP, a Viresolve-180R module (Millipore Corporation) (20 stacks) for 27.208 L of Precipitation II resuspension was installed. The Pellicon CIP / SIP module was replaced with 2 Biomax-50 filter frames. The Viresolve-180R module is chlorine sterilized and washed. Rinse the Biomax-50 filter frame with WFI U.S.P. Benzalkonium chloride (Roccal) was assayed on the last permeated rinse sample; benzalkonium chloride concentration was 8 ppm. Diffusion testing was performed on a Biomax-50 filter frame; the release rate was calculated as previously described; the total release ...

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Abstract

Methods for producing immunoglobulins and in particular anti-D immunoglobulin substantially free of virus and product resulting therefrom. Specifically provided are methods for nanofiltration of the anti-D immunoglobulin in high ionic strength buffer and with excipient such as polysorbate 80. Additional steps include diafiltration to concentrate the anti-D protein and reduce the concentration of excipient present.

Description

field of invention [0001] The field of the present invention is the recovery of large protein substances through a small pore size exclusion filter (filter) during the process of purifying, reducing or eliminating viruses. An obstacle to the separation of viruses from large biomolecules such as gamma globulins by size exclusion is the difficulty in passing the large globulins through the required small pore size filters for pharmaceutical or diagnostic applications. Eliminating viruses from protein molecules by the method of the present invention results in substantially virus-free products. Background of the invention [0002] In the process of purifying, reducing or removing viruses, it is an important problem in the current pharmaceutical and diagnostic industries to recover large protein substances through small pore size exclusion filters (filter) (see Roberts, PVox Sang, 1995; 69:82 -83). An obstacle to the separation of viruses from large biomolecules such as monoc...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61L2/00A61P37/02C07K1/34C07K16/00C07K16/06C07K16/34
CPCY10S977/906Y10S977/92A61L2/0017Y10S977/84C07K2317/21C07K16/065Y10S977/88C07K16/34A61P37/02C07K16/00
Inventor R·W·范霍尔滕G·E·小乌伦森
Owner ORTHO-CLINICAL DIAGNOSTICS
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