Patent US4723281A successfully refreshed from Google Patents.
US4124576A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Method of producing intravenously injectable gamma globulin
Assignee: Individual
•
Filing: 1976-12-03
•
Granted: 1978-11-07
•
Expires: 1996-12-03
Abstract
Abstract An improved process is provided for the preparation of a gamma globulin suitable for intravenous administration from the readily available Fraction II or II + III plasma protein paste or from the corresponding fractions originating from placental extracts. The Fraction II or II + III paste is extracted with water at a pH of 4.9 to 6.0 and impurities are fractionally precipitated by addition of polyethylene glycol to 4% of wt./vol. and then 6% vol. ethanol. The desired gamma globulin is then precipitated at a pH 8.0 by addition of polyethylene glycol to 12% wt./vol.
Inventors
- 👤 Myer L. Coval
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-25 05:17
CPC Classifications
A; A61; A61K; A61K39/00; A61K39/395; C; C07; C07K; C07K16/00; C07K16/06; A61K38/00; Y; Y10; Y10S; Y10S530/00; Y10S530/827; Y10S530/829; Y10S530/83; Y10S530/831; Y10S530/85; Y10S530/851
Claims Analysis
Total Claims: 9
Claim 1
Independent Claim
172 words
A process for preparing a gamma globulin substantially devoid of anticomplementary activity and suitable for intravenous administration, from a material selected from the Fraction II + III plasma protein paste having a protein content of about 25-30%, Fraction II paste and placental extracts containing these fractions which comprises the steps: a. suspending said paste in water to form a solution of low ionic strength having a conductance of about 300 × 10 -6 cm -1 ohm -1 at a pH of about 4.9 to 6.0 to produce a precipitate and a filtrate, b. precipitating impurities from said filtrate by adding polyethylene glycol to 4% weight/volume, c. further precipitating impurities by the addition of ethanol in a concentration of from 4 to 12% and d. precipitating the gamma globulin by adding polyethylene glycol to 10 to 12% weight/volume or by adding ethanol to 20 to 30% v/v, preferably 25% at a pH of from 7 to 8.2, preferably 8.0. said process being carried out at a temperature of about 0° to -6° C.
Claim 2
Dependent Claim
172 words
A process for preparing a gamma globulin substantially devoid of anticomplementary activity and suitable for intravenous administration, from a material selected from the Fraction II + III plasma protein paste having a protein content of about 25-30%, Fraction II paste and placental extracts containing these fractions which comprises the steps: a. suspending said paste in water to form a solution of low ionic strength having a conductance of about 300 × 10 -6 cm -1 ohm -1 at a pH of about 4.9 to 6.0 to produce a precipitate and a filtrate, b. precipitating impurities from said filtrate by adding polyethylene glycol to 4% weight/volume, c. further precipitating impurities by the addition of ethanol in a concentration of from 4 to 12% and d. precipitating the gamma globulin by adding polyethylene glycol to 10 to 12% weight/volume or by adding ethanol to 20 to 30% v/v, preferably 25% at a pH of from 7 to 8.2, preferably 8.0. said process being carried out at a temperature of about 0° to -6° C.
Claim 3
Dependent Claim
18 words
A process according to claim 1 wherein the pH at which the paste is extracted is about 5.1.
Claim 4
Dependent Claim
19 words
A process according to claim 1 wherein the polyethylene glycol has a molecular weight of about 4,000 to 6,000.
Claim 5
Dependent Claim
17 words
A process according to claim 4 wherein the polyethylene glycol has a molecular weight of about 4,000.
Claim 6
Dependent Claim
18 words
A process according to claim 4 wherein the process is carried out at a temperature of about -2.
Claim 7
Dependent Claim
72 words
A lyophilized gamma globulin prepared by the method of claim 1 suitable for intravenous administration which has from zero to about 0.02 units per mg. of anticomplementary activity, a sedimentation coefficient of 7S, contains no aggregates and degradation products F(ab) 1 , F(ab) 2 or Fc, readily dissolves in water to give clear and colorless solutions, and whose antibody spectrum levels and sublcass distribution are unaltered from that of the starting material.
Claim 8
Dependent Claim
28 words
The process of claim 1 wherein the starting material is a placental extract and the solutions of steps a, b and c are subjected to a skimming operation.
Claim 9
Dependent Claim
22 words
The process of claim 1 wherein the initial suspension is made in water containing about 2% polyethylene glycol and about 0.2% albumin.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1981-11-06 | 1982-05-08 | 1982-11-07 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1985-11-06 | 1986-05-08 | 1986-11-07 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1989-11-06 | 1990-05-08 | 1990-11-07 | $7700.00 | Window Closed / Lapsed |