You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Claims for Patent: 4,169,829


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 4,169,829
Title: Process for the preparation of purified albumin and albumin obtained by said process
Abstract:Purified albumin is prepared from frozen placenta, placental blood or other hemolyzed blood by the steps of eliminating hemoglobin, eliminating enzymes and eliminating group substances.
Inventor(s): Plan; Robert (Lyons, FR), Liautaud; Jacques (Limonest, FR), Makula; Marie-France (Lyons, FR), Gattel; Paule (Caluire, FR), Pla; Jean (Sainte-Foy-les-Lyon, FR), Debrus; Andre (Lyons, FR)
Assignee: Institut Merieux (Paris, FR)
Application Number:05/838,054
Patent Claims:1. A process for preparing purified human albumin essentially free of group substances and alkaline phosphatases from a starting impure albumin solution obtained from placental blood or hemolyzed venous blood from which solution hemoglobins and globulins have been eliminated, which comprises adding ethanol to said impure albumin solution in an amount sufficient so that the ethanol concentration is greater than 55%, adding trichloroacetic acid to said ethanol-containing solution in an amount sufficient so that the concentration therein is from 5.times.10.sup.-2 to 8.times.10.sup.-2 M/liter and adjusting the temperature to lower than 0.degree. C. whereby a precipitate containing said group substances and alkaline phosphatases is formed and removing the thus formed precipitate.

2. The process of claim 1 wherein the ethanol-containing solution to which said trichloroacetic acid is added contains proteins in an amount lower than or equal to 10 g/l and the ethanol concentration is about 75%.

3. The process of claim 1 wherein trichloroacetic acid is added at a temperature of -5.degree. to -10.degree. C.

4. The process of claim 1 wherein the starting impure albumin solution is a solution of placental blood from which globulins have been eliminated by precipitation with the addition of ethanol at a concentration of 25% and by removal therefrom of the resulting precipitated globulins.

5. The process of claim 4 wherein said starting impure albumin solution is said solution of placental blood from which a significant amount of the hemoglobin content thereof has also been eliminated subsequent to the elimination of said globulins and prior to the removal of said group substances and alkaline phosphatases by adding to said essentially globulin-free solution sufficient chloroform to precipitate a major portion of said hemoglobin, adjusting the pH thereof to between 6.0 and 6.1, removing the precipitated hemoglobin and thereafter concentrating the remainder so that the protein content therein is lower than or equal to 10 g/l.

6. The process of claim 5 wherein the step of concentrating the said remainder subsequent to the removal of the said precipitated hemoglobin consists of cooling the remainder to a temperature between -5.degree. and -10.degree. C., adding sufficient trichloroacetic acid or polyphosphoric acid thereto to form an albumin-containing precipitate, recovering said albumin-containing precipitate, and dissolving said recovered albumin-containing precipitate in an alkaline solution at neutral pH, the amount of alkaline solution used being such that the concentration of proteins therein does not exceed 10 g/l.

7. The process of claim 6 which includes subsequent to dissolving said recovered albumin-containing precipitate in said alkaline solution, adding thereto silica powder in an amount sufficient to form a precipitate and thereafter removing said precipitate.

8. The process of claim 1 which includes subsequent to the removal of said group substances and alkaline phosphatases, thermocoagulating the remainder in the presence of caprylate in an amount sufficient to remove the last traces of hemoglobin.

9. The process of claim 8 wherein the caprylate is sodium caprylate.

10. Process according to claim 8 wherein thermocoagulation is carried out after having adjusted the protein concentration to a value not greater than 50 g/liter, and at a pH between 4.5 and 5.5 and at a temperature between 52.degree. C. and 64.degree. C.

11. The process of claim 10 wherein the thermocoagulation temperature is between 56.degree.-60.degree. C.

12. Process according to claim 9 wherein the sodium caprylate concentration is between 2 and 12 g/liter.

13. Process according to claim 8 wherein thermocoagulation is carried out for a period greater than 1/2 hour.

14. A process for preparing purified human albumin essentially free of group substances and alkaline phosphatases from a starting impure albumin solution obtained from placental blood or hemolyzed venous blood comprising the steps of

(a) adding ethanol to said placental blood or hemolyzed venous blood in an amount sufficient so that the ethanol concentration therein is about 25% whereby a precipitate containing globulins is formed and a supernatant containing ethanol in a concentration of about 25% hemoglobins, albumin, group substances and alkaline phosphates, is formed,

(b) adding chloroform to said supernatant from (a), adjusting the pH thereof to a value between 6.0 and 6.1 and maintaining said supernatant at a temperature of about 24.degree. C. whereby a precipitate containing said hemoglobins is formed and discarded and a supernatant containing about 25% ethanol, albumin, group substances and alkaline phosphatases is formed,

(c) adding trichloroacetic acid to the supernatant from (b) containing ethanol at a concentration of about 25% in an amount sufficient so that the concentration of said trichloroacetic acid therein is about 3.times.10.sup.-2 to 10.times.10.sup.-2 M/liter and adjusting the temperature to about -5.degree. to -10.degree. C. whereby a supernatant containing said alkaline phosphatases is formed and discarded and a precipitate containing said albumin and group substances is formed,

(d) dissolving said precipitate from (c) in dilute NaOH to a neutral pH,

(e) adding to the solution resulting from (d) silica to clarify the same whereby a precipitate is formed and discarded and a clarified supernatant containing said albumin and said group substances is formed,

(f) adding to the clarified supernatant from (e) a mixture of ethanol and trichloroacetic acid the concentration of ethanol being about 75% and the concentration of trichloroacetic acid being about 5.times.10.sup.-2 to 8.times.10.sup.-2 M/liter at a temperature between -5.degree. to -10.degree. C. whereby a precipitate containing said group substances is formed and discarded together with any residual alkaline phosphatases, and a supernatant containing said albumin is formed,

(g) adjusting the pH of the supernatant from (f) to a value between 6.5 and 7, at a temperature between -5.degree. and -10.degree. C. whereby a supernatant is formed and discarded and a precipitate containing said albumin is formed.

15. A process for preparing purified human albumin essentially free of group substances and alkaline phosphatases from a starting impure albumin solution obtained from placental blood or hemolyzed venous blood comprising the steps of

(a) adding sufficient ethanol to said placental blood or hemolyzed venous blood so that the ethanol concentration therein is about 25% whereby a precipitate containing globulins is formed and discarded and a supernatant containing about 25% ethanol, hemoglobins, albumin, alkaline phosphatases and group substances if formed,

(b) adding to the supernatant from (a) chloroform and adjusting the pH to a value between 6.0 and 6.1 while maintaining the temperature of about 24.degree. C. whereby a precipitate containing said hemoglobins is formed and discarded and a supernatant containing about 25% ethanol, albumin, group substances and alkaline phosphatases is formed,

(c) adding to the supernatant from (b) trichloroacetic acid to provide a concentration therein of about 3.times.10.sup.-2 to 10.times.10.sup.-2 M/liter and adjusting the temperature to about -5.degree. to -10.degree. C. whereby a supernatant containing said alkaline phosphatases is formed and discarded and a precipitate containing said albumin and group substances is formed, and

(d) adding to the precipitate from (c) a mixture of ethanol and trichloroacetic acid, the concentration of ethanol being about 75% and the concentration of trichloroacetic acid being about 5.times.10.sup.-2 to 8.times.10.sup.-2 M/liter and maintaining the temperature between -5.degree. and -10.degree. C. whereby a precipitate containing said group substances is formed and discarded together with any residual alkaline phosphatases and a supernatant containing said albumin is formed.

16. Purified albumin and human placental origin free of group substances and alkaline phosphatases.

Details for Patent 4,169,829

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5 albumin (human) For Injection 101138 10/21/1942 ⤷  Try a Trial 1996-10-02
Baxalta Us Inc. BUMINATE, FLEXBUMIN albumin (human) Injection 101452 03/03/1954 ⤷  Try a Trial 1996-10-02
Csl Behring Ag ALBURX albumin (human) Injection 102366 07/23/1976 ⤷  Try a Trial 1996-10-02
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.