Unlock instant, AI-driven research and patent intelligence for your innovation.

Factor VIII formulation

一种凝血因子、分子的技术，应用在因子VIII制剂领域

Active Publication Date: 2017-05-17
JET
View PDF39 Cites 5 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The second major concern with FVIII formulations is their stability after lyophilization

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Factor VIII formulation
  • Factor VIII formulation
  • Factor VIII formulation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0341] Preparation of FVIII formulations and evaluation of solution properties following buffer exchange through a desalting column

[0342] According to the supplier's instruction, through NAP-25 desalting column (GE Healthcare Sephadex TM G 25; Cat. No. 17-0852-01) Buffer exchange Purified CSL627 with a FVIII:C activity (chromogenic substrate method) of 9500 IU / ml was formulated into the desired composition. This buffer exchange resulted in a dilution factor of 1.4.

[0343] The yield of the different compositions on FVIII:C activity and its appearance (turbidity) were then studied.

[0344] The yield of FVIII:C was calculated as the percentage of the amount of FVIII:C in the composition obtained after buffer exchange divided by the amount of FVIII:C in the solution before buffer exchange, by buffer exchange (dilution factor 1.4 ) to adjust the dilution appropriately.

[0345] Table 18

[0346]

[0347] *FVIII:C activity yield determined by chromogenic substrate activ...

Embodiment 2

[0349] Preparation of FVIII formulations and evaluation of solution properties following buffer exchange through a desalting column

[0350] Different compositions were obtained by buffer exchange as described in Example 1 (FVIII:C activity in the starting material was 9733 IU / mL). The composition was evaluated for its appearance after buffer exchange. In addition, the compositions were subsequently sterile filtered (0.22 μm) and their FVIII:C activity was determined directly after filtration (time 0) and stored at +2–+8°C for 1, 2, 3, 15, 30 and 60 days and after storage at +25°C and +40°C for 1, 2 and 3 days their FVIII:C activity was determined.

[0351] Recovery (stability) was calculated as percent of FVIII:C after storage (chromogenic substrate FVIII activity assay) divided by FVIII:C activity at time 0. The FVIII:C activity at time 0 (after 0.22 μm filtration) was defined as 100%.

[0352] Table 19

[0353]

[0354] *FVIII:C recovery is based on FVIII:C activity me...

Embodiment 3

[0362] Appearance of the solution after buffer exchange through the desalting column

[0363] The different compositions were obtained by buffer exchange as described in Example 1 (FVIII:C activity in the starting material determined by the activity of the chromogenic substrate FVIII was 8317 IU / mL). The composition was evaluated for its appearance after buffer exchange.

[0364] Table 22

[0365]

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention relates to factor VIII compositions and their use.

Description

[0001] Background of the invention [0002] Factor VIII (FVIII) is a protein found in plasma that acts as a cofactor in the cascade of reactions leading to blood clotting. Deficiency in the amount of FVIII activity in the blood results in a blood clotting disorder known as hemophilia A, a genetic disorder that primarily affects males. Hemophilia A is currently treated with therapeutic preparations of FVIII derived from human plasma or produced using recombinant DNA techniques. Such formulations are administered in response to bleeding episodes (on-demand therapy) or at frequent, regular intervals to prevent uncontrolled bleeding (prophylaxis). [0003] FVIII is known to be relatively unstable in therapeutic formulations. In plasma, FVIII is normally complexed with another plasma protein, vonWillebrand factor (vWF), which is present in plasma in a large molar excess of the VWF subunit to FVIII and is thought to protect FVIII from premature degradation. Another circulating plas...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/37A61K9/19A61K9/08A61K47/18A61K47/26A61K47/02A61P7/04
CPCA61K9/0019A61K9/08A61K9/19A61K38/37A61K47/02A61K47/183A61K47/26A61K47/20A61P7/04A61K47/18A61K47/22A61K9/0095C07K14/755
Inventor U·礼宾H·梅岑C·波登本德尔
Owner JET