Sterilization and filtration of peptide compositions

Patent metadata

Field	Value
Publication number	US-11090398-B2
Application number	US-201816171734-A
Country	US
Kind code	B2
Filing date	Oct 26, 2018
Priority date	Mar 10, 2014
Publication date	Aug 17, 2021
Grant date	Aug 17, 2021

Abstract

Methods and devices for sterilizing viscous peptide compositions which have shear thinning rheological properties at high concentrations.

First claim

What is claimed is:

1. A method for sterilizing a liquid peptide composition having an initial storage modulus within the range of about 300 to about 5,000 Pa at 1 rad/sec of frequency and 1 Pa of oscillation stress,
the method comprising steps of:
subjecting the liquid peptide composition to high shear stress so that a storage modulus of the liquid peptide composition is temporarily reduced to a reduced level within a range of about 0.01% to 80% of the initial storage modulus; and
subjecting the liquid peptide composition to filtration while the storage modulus is at the reduced level.

2. The method of claim 1 , wherein the step of subjecting the liquid peptide composition to high shear stress uses at least one shear-thinning unit.

3. The method of claim 2 , wherein the at least one shear-thinning unit is or comprises at least one needle.

4. The method of claim 3 , wherein the at least one needle is at least 1 mm long.

5. The method of claim 3 , wherein the at least one needle has a gauge within the range of about 25 to about 35.

6. The method of claim 2 , wherein the at least one shear-thinning unit is or comprises at least one screen with micro- or nano-sized holes.

7. The method of claim 6 , wherein the micro- or nano-sized holes have a largest dimension within a range of about 0.5 μm to about 200 μm.

8. The method of claim 6 , wherein a pinch between the micro- or nano-sized holes is about 5 μm to about 10 mm.

9. The method of claim 6 , wherein the at least one screen is made at least in part of a material selected from the group consisting of stainless-steel, tungsten, titanium, silicon, ceramic, plastic, and combination thereof.

10. The method of claim 6 , wherein thickness of the at least one screen is about 10 μm to about 10 mm.

11. The method of claim 2 , wherein the at least one shear-thinning unit is or comprises at least one membrane with micro- or nano-sized pores.

12. The method of claim 11 , wherein the micro- or nano-sized pores have a size within a range of about 0.45 μm to about 120 μm.

13. The method of claim 1 , wherein the high shear stress is within a range of about 30 to about 200 Pa.

14. The method of claim 1 , wherein the liquid peptide composition comprises RADA16 as set forth in SEQ ID NO:1, or KLD12 as set forth in SEQ ID NO: 2.

15. The method of claim 1 , wherein the liquid peptide composition is pressurized prior to filtration.

16. The method of claim 1 , further comprising storing the liquid peptide composition under vacuum.

Assignees

• 3 D Matrix Ltd

Inventors

• Gil Eun Seok
• Gilbert Karl Patrick

Classifications

• A61L2103/05

  Living organisms or biological materials · CPC title

• A61L2/022 Primary

  Filtration · CPC title

• A61L2/04 Primary

  Heat (radiation A61L2/08) · CPC title

• A61L2/07 Primary

  Steam · CPC title

• C07K7/08

  having 12 to 20 amino acids (gastrins C07K14/595; somatostatins C07K14/655; melanotropins C07K14/68) · CPC title