Method for continuous, automated blending of solutions from acids and bases

• US 20040102380A1
• Filed: 11/18/2003
• Published: 05/27/2004
• Est. Priority Date: 11/18/2002
• Status: Abandoned Application

• Current Assignee: Taurus HSA LLC
• Original Assignee: Taurus HSA LLC
• Inventors: Fulton, Scott P., Brown, Peter G.
• Application Number:
  US10/715,701
• Publication Number:
  US 20040102380A1
• Time in Patent Office: Days
• US Class Current: 514/12
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 1/18 for pancreatic disorders, e.g. pancreatic enzymes
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 7/10 Antioedematous agents; Diuretics
• CPC Class Codes: C07K 14/4715 Pregnancy proteins, e.g. placenta proteins, alpha-feto-protein, pregnancy specific beta glycoprotein
• CPC Class Codes: C07K 14/765 Serum albumin, e.g. HSA

Abstract

The present invention relates to an improved method to process, purify and/or produce biopharmaceuticals or other products involving automated blending of pH buffered solutions from water and common stocks of concentrated acids and bases, and other components. This approach reduces the cost and complexity of the solution preparation systems required for producing these solutions under aseptic or sterile conditions, and reduces the material costs of the solutions themselves. This approach is particularly beneficial to use with continuously-produced feedstocks and with continuous separation operations.

Claims

1. A method for the production of aqueous pH buffered solutions or formulations comprising:

a) blending of water in a controlled manner; and

b) buffering acids and bases in solution at a controlled ratio to produce the desired final pH and buffer concentration from a source of constitutive acids and bases,

2. The method of claim 1 wherein any other other required ingredients of said buffered solution are added at a controlled ratio to produce the desired final concentration of each ingredient.

3. The method of claim 1 wherein said buffered solutions of the invention are used to process a biopharmaceutical.

4. The method of claim 1 wherein said biopharmaceutical is human serum albumin.

5. The method of claim 1 wherein the production of said buffered solutions is done continuously.

6. The method of claim 5 wherein a product feedstream is processed through simulated moving bed chromatography.

7. The method of claim 6 wherein a product feedstream is transgenic in origin.

8. The method of claim 7 wherein said transgenic product feedstream is milk.

9. The method of claim 6 wherein a product feedstream is derived from a cell culture broth.