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US4480029A
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Biological indicators and their use
Assignee: Baxter International Inc
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Filing: 1981-04-27
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Granted: 1984-10-30
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Expires: 2001-04-27
Abstract
Abstract Biological indicators are used to evaluate the effectiveness of virus inactivation conducted on virus-contaminated, protein-containing compositions. The indicators comprise dry protein and a predetermined titer of infectious virus.
Inventors
- 👤 Gary H. Dolana
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-26 12:08
CPC Classifications
C; C12; C12Q; C12Q1/00; C12Q1/70; C12Q1/56; Y; Y10; Y10S; Y10S435/00; Y10S435/814; Y10T; Y10T436/00; Y10T436/10; Y10T436/106664; Y10T436/108331
Claims Analysis
Total Claims: 2
Claim 1
Independent Claim
131 words
A method for testing the efficacy of a viral inactivation method, which viral inactivation method consists essentially of heating a dry sample of AHF and/or at least one blood clotting enzyme suspected to contain such virus until the sample is substantially free of infectious virus and denatured blood clotting enzyme, comprising (a) preparing a lyophilized biological indicator comprising a predetermined titer of infectious virus and AHF and/or at least one blood clotting enzyme, said AHF being present in a concentration of greater than about 35 International Units of AHF per gram of protein and said enzyme being purified about from 3 to 50 fold over its concentration in normal human plasma; (b) exposing the indicator to said viral inactivation method; and (c) assaying for any infectious virus remaining in the indicator.
Claim 2
Independent Claim
131 words
A method for testing the efficacy of a viral inactivation method, which viral inactivation method consists essentially of heating a dry sample of AHF and/or at least one blood clotting enzyme suspected to contain such virus until the sample is substantially free of infectious virus and denatured blood clotting enzyme, comprising (a) preparing a lyophilized biological indicator comprising a predetermined titer of infectious virus and AHF and/or at least one blood clotting enzyme, said AHF being present in a concentration of greater than about 35 International Units of AHF per gram of protein and said enzyme being purified about from 3 to 50 fold over its concentration in normal human plasma; (b) exposing the indicator to said viral inactivation method; and (c) assaying for any infectious virus remaining in the indicator.
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) | 1987-10-30 | 1988-04-30 | 1988-10-30 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1991-10-30 | 1992-04-30 | 1992-10-30 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1995-10-30 | 1996-04-30 | 1996-10-30 | $7700.00 | Window Closed / Lapsed |