LV10195B - Composition for stabilizing blood plasma during pasteurization and pasteurized plasma solution for therapeutic use - Google Patents

Composition for stabilizing blood plasma during pasteurization and pasteurized plasma solution for therapeutic use Download PDF

Info

Publication number
LV10195B
LV10195B LVP-93-113A LV930113A LV10195B LV 10195 B LV10195 B LV 10195B LV 930113 A LV930113 A LV 930113A LV 10195 B LV10195 B LV 10195B
Authority
LV
Latvia
Prior art keywords
plasma
composition
composition according
concentration
lysine
Prior art date
Application number
LVP-93-113A
Other languages
Latvian (lv)
Other versions
LV10195A (en
Inventor
Miryana Nee Radosevich Burnouf
Original Assignee
Aetsrn
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Aetsrn filed Critical Aetsrn
Publication of LV10195A publication Critical patent/LV10195A/en
Publication of LV10195B publication Critical patent/LV10195B/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0023—Heat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Diabetes (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • External Artificial Organs (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The invention relates to a composition intended to stabilise blood plasma during pasteurisation, the blood plasma being whole or devoid of cryoproteins. The composition according to the invention makes it possible to pasteurise very large quantities of plasma (of the order of 60 litres). The invention also relates to the method for pasteurisation of the plasma using the stabilising composition. The pasteurised plasma obtained is intended for therapeutic use.

Description

LV 10195
Composition for stabilizing blood plasma during pasteurization and pasteurized plasma solutlon for therapeutic use.
The invention relates to a composition permitting the stabilization of blood plasma during pasteurization, a process using the said composition and the plasma Solutions thus obtained, intended, in particular, for plasma filling treatments or blood coagulation factor substitution treatments.
Total or cryoprotein-free human plasma is stili used in "filling treatments" for persons suffering from severe burns or serious injuries, or those who have undergone major surgery, that is to say in ali cases in which patients experience heavy fluid losses.
For this type of treatment, use is generally made of plasma fr.om individual donations by healthy subjects who have undergone prior Controls, to preclude any risks of transmission of virai diseases. This procedure does not make it possible, however, to eliminate ali the risks of contamination by viruses in the pre-serological stage, in particular the different hepatitis and AIDS viruses.
It thus stili seems important to continue developing virai inactivation methods and stabilizing compositions that preserve the essential biological functions of the plasma.
It has been demonstrated that the Hepatitis B virus is totally inactivated by heating at 60°C for 10 hours, in the presence of 0/5 M of sodium citrate (Tabor et al. Thromobosis Res. 22, 1981, 233-238). Hovever, this treatment leads to a loss of biological activity for certain proteīns in the plasma (Tabor et al. and Barrowcliffe et al. Fr. J. Hematology 55, 1983, 37-46).
It has proved possible to subject different proteīns of therapeutic value, purified from blood plasma, to conventional pasteurization at 60°C for 10 hours in the presence of various stabilizing aģents. It is noted, however, that compositions that stabilizē one biological activity may have absolutely no effect on another.
These different items of experimental data have given rise to the impression that virai inactivation of total plasma (fresh plasma or frozen fresh plasma) or cryoprotein-free plasma could not be achieved by pasteurization.
However, as there exists a medical requirement for total plasma, the Applicant has sought to develop compositions ensuring simultaneous protection of biological activity from denatiration in the course of pasteurization for ali the factors of therapeutic value contained in the plasma.
Thus, in French patent application No. 90 08375, the Applicant showed that a mixture of sorbitol, heparin. 2 LV 10195 lysine and CaCl2 efficiently stabilized the biological activity of the plasma factors during the pasteurization process.
However, owing the presence of heparin in this stabilizing mixture, and thus in the final preparation, patients already undergoing heparin treatment cannot be injected with this plasma.
That is why the Applicant has sought for another composition performing the same stabilizing function.
Having previosly observed that sorbitol afforded a certain degree of protection from thermal denaturation/ but with results that varied from one plasma sample to another, and with low efficiency, the Applicant sought for different additives which, by being mixed with the sorbitol, would increase its stabilizing power, and, in particular, it obtained good results by adding a quantity of saccharose approximating to 50% of the quantity of sorbitol.
On the other hand, as the CaCl2 was observed to be unstable in the course of prolonged heating, it was replaced by calcium gluconate which possesses good resistance to pasteurizing conditions.
Furthermore, the addition of trisodium citrate enhanced the protecting effect of the mixture, provided that its concentration was carefully adjusted, as too small a dose permits spontaneous coagulation of the plasma, while too large a dose slows down the subsequent activity of the coagulation factors during therapeutic use of the plasma.
Finally, at least two amino acids, preferably lysine and arginine, are added to the mixture. 3
The stabilizing composition according to the invention is thus composed of a mixture of sorbitol, saccharose, calcium gluconate, trisodium citrate, lysine and arginine. The following concentrations of the different additives are used for one liter of initial plasma to be pasteurized: -sorbitol, 800 to 1,400 g, and preferably 1,300 g -saccharose, 400 to 600 g, and preferably 514 g and preferably 4 mM and preferably 15 mM and preferably 5 g and preferably 5 g -calcium gluconate, 3 to 5 mM, -trisodium citrate, 8 to 25 mM, -lysine, 1 to 10 g, -arginine, 1 to 10 g,
The composition according to the invention is added to the fresh plasma, or to the frozen and thawed fresh plasma, or to the plasma free of the proteīns of the cryoprecipitate, before said plasma is subjected to pasteurization by heating at 60°C ± 1°C, in a liquid State, for 10 hours.
After pasteurization, the temperature is gradually lowered to 20°C and the solution is subjected to dialysis in order to remove the sorbitol and the saccharose. The dialysis buffer is at a pH of 7,5 and contains 10 mM of trisodium citrate, 4 mM of calcium gluconate, 0,1 M of sodium chloride, lysine at a concentration of 10 g/1 and arginine at a concentration of 3 g/1. Dialysis buffers of different compositions can also be used according to requirements. The solution is then concentrated to restore the physiological dose of the plasma proteīns. The resulting solution undergoes clarifying filtration, and then sterilizing filtration, and is then dispensed and deep frozen or freeze dried. 4 LV 10195
The invention also relates to the plasma pasteurizing process which includes the addition to the plasma of the composition according to the invention, prior to its heating, and then dialysis of the pasteurized plasma against the buffer as defined hereabove.
This process is particularly advantageous because it can be applied to large batches of plasma from several separate harvests and can range from 1 liter to several hundreds of literes. The pasteurization of batches in the order of 60 liters or more, after the appropriate Controls have been conducted, thus enables the consistant biochemical quality of the product to be guaranteed.
The invention also relates to the pasteurized plasma Solutions obtained using the process according to the invention, the said Solutions including total plasma or plasma free of certain proteīns (such as the proteīns of the cryoprecipitate) and intended for therapeutic use, either to replace total plasma or to compensate for a deficiency in a particular blood factor.
The composition and the process according to the invention can also be applied to plasma of animal origin. They can be advantageously applied, for example, to bovine foetal serum used as an additive for celi cultures intended more particularly for the preparation of therapeutic products.
The following example describes a form of embodiment of the invention without, however, limiting its scope. 5 LV 10195
Example
The following mixture is added to sixty liters of thawed plasma, vith gentle stirring: quantity per litre of initial plasma sorbitol 1,300 g saccharose 514 g calcium gluconate 4 mM trisodium citrate 15 mM lysine 5 g arginine 5 g
Pasteurization is carried out in a thermostatically controlled tank by heating at 60°C for 10 hours.
After pasteurizing, the temperature is gradually lowered to 20°C, and then the solution is subjected to dialysis to remove the sorbitol and the saccharose.
Dialysis is carried out, for example, using a cassette-based ultrafiltration systeni (Pellicon (R)) .
The composition of the dialysis buffer is as follows:
-trisodium citrate 10 mM -lysine 10 mM -arginine 3 g/i -calcium gluconate 4 mM -sodium chloride 0, 1 M
Removal of the sorbitol is checked by enzymatic analysis, applied to the finished product. 6
Dialysis can be followed, as applicable, by concentration using the same equipment to restore the coagulation factor yields to approximately 1 U/ml, as in a good quality therapeutic plasma. The product is dialyzed at an osmotic pressure of 370 mosmol/1 and at a pH of 7 to 7.5.
The product is then sterilized by filtration, for example using a Millipack(R) 40 (Millipore (R)) with 0.22 μιη pores. Then the product is dispensed in plastic bags or bottles for deep freezing or freeze drying.
The efficiency of pasteurization in virai inactivation was evaluated for an assortment of viruses recommended by the "group of experts in biotechnology/pharmacology of the European authorities for the validation of processes of elimination and virai inactivation of biological products".
The results are set out in the following table: VĪRUS GENOME STRUCTURE REDUCTION OF INFECTIVI TY (LOG 10) DURATION HIV RNA E >5 <10 min. POLIO SABIN 1 RNA NE >6,23 <5 hours VACCINE DNA E >4.30 <1 hour HERPES DNA E >4.15 <5 hours AUJESZKY PARAINFLUENZA RNA E >6,30 <2 hours ΤΥΡΕ 3 REOVIRUS ΤΥΡΕ 3 RNA NE >3,28 <10 hours SINDBIS RNA E >5,74 <5 hours 7 LV 10195 E=with an envelope NE= non enveloped
The results of the quality Controls carried out on 6 consecutive pilot batches are given in the following tables.
Table II. Recovery of blood factors CONCENTRATION (u/ml) YIELD (%) Proteins (g/1) 60,0 ± 106 93 + 2 Factor VIII:c (IU/ml) 1,10 ± 0,26 94 ± 7 Factor VIII:c (chromogenic) 0,70 ± 0,09 83 ± 13 Factor V:c 1,12 ± 0,25 83 ± 4 Factor XI:c 0,98 ± 0,06 88 ± 7 Factor IX:c 0,64 ± 0,10 59 ± 7 Factor VII:c 0,65 ± 0,5 67 ± 6 Fibrinogen Ag (g/1) 3,10 ± 0,28 92 ± 5 Clottable fibrinogen Ag (g/1) 2,50 ± 0,17 92 + 3 Antithrombin III activity (g/1) 0,99 ± 0,04 92 ± 3 Alpha-l-antitrypsin activxty (g/1) 0,96 ± 0,10 92 ± 3 APTT 35-38 seconds 8
Table III. Quality control; absence of and degradation products CONCENTRATION (U/l) Thrombin <0,01 PKA (%) <2 Kallikrein (%) <3 Factor IXa (U/ml) <0,1 Factor Xa (U/ml) <0,1 Factor VIIb/FVIIa 0,97 Proteolytic activity (S.2288-OD/mn) 0,03 Fibrinogen degradation products (ng/ml) <250
Table IV. In vivo quality control on animals
Tests on rats: -Blood pressure <-2% -Heart beats unchanged -Txicicity (intraveinous injection-25 ml/kg) absence of toxicity Tests on rabbits: -pyrogenicity non-pyrogenic
The plasma pasteurized in the presence of the stabilizing composition defined hereabove complies with the standards laid down for therapeutic use. 9 LV 10195 filAIMfl 1 Composition for stabilizing blood plasma during pasteurization, characterized in that it is composed of a mixure of sorbitol, saccharose, calcium gluconate, trisodium citrate, lysine and arginine. 2. Composition according to claim 1, characterized in that the sorbitol concentration is between 800 and 1/400 g/litre of initial plasma. 3. Composition according to claim 2, characterized in that the sorbitol concentration is 1,300 g/1. 4. Composition according to any one of claims 1 to 3, characterized in that the saccharose concentration is between 400 and 600 g/1. 5. Composition according to claim 4, characterized in that the saccharose concentration is 514 g/1. 6. Composition according to any one of claims 1 to 5, characterized in that the compos.ed of a mixure of i r\ sorbitol, saccharose, calcium gluconate concentration is between 3 and 5 mM. 7. Composition according to claim 6, characterized in that the calcium gluconate concentration is 4 mM. 8. Composition according to any one of claims 1 to 7, characterized in that the trisodium citrate concentration is between 8 and 25 mM. 9. Composition according to claim 8/ characterized in that the calcium gluconate concentration is 15 mM. 10. Composition according to any one of claims 1 to 7, characterized in that the lysine and arginine concentrations is between 1 and 10 g/1. 11. Composition according to claim 10, characterized in that the lysine and arginine concentrations are 5 g/1. 12. Process for pasteurizing blood plasma, characterized in that it includes the addition to the plasma of the composition according to any one of claims 1 to 11 prior to the heating step, and then removal of the sugars from the said composition, after the heating step, by dialysis against a buffer containing trisodium citrate, calcium gluconate, sodium chloride, lysine and arginine. 13. Process according to claim 12, characterized in that the dialysis buffer contains 10 mM of trisodium citrate, 4 mM of calcium gluconate, 0,1 M of sodium chloride, 10 g/1 of lysine and 3 g/1 of arginine. 11 LV 10195 14. Process according to claim 12 or 13, characterized in that it is applicable to volumes of plasma of between 1 litre and several hundreds of litres. 15. Total plasma for therapeutic use, characterized in that it has been pasteurized using the process according to any one of claims 12 to 14. 16. Cryoprecipitated plasma supernatant for therapeutic use, characterized in that it has been pasteurized using the process according to any one of claims 12 to 14. 17. Plasma or serum of animal origin, characterized in that it has been pasteurized using the process according to any one of claims 12 to 14.

Claims (17)

LV 10195 Izgudrojuma formula 1. Sastāvs asins plazmas stabilizācijai pasterizācijas laikā, atšķirīgs ar to, ka tas sastāv no sorbita, saharozes, kalcija glukonāta, trinātrija citrāta, lizīna un arginīna maisījuma.Composition for the stabilization of blood plasma during pasteurization, characterized in that it consists of a mixture of sorbitol, sucrose, calcium gluconate, trisodium citrate, lysine and arginine. 2. Sastāvs saskaņā ar 1. p., atšķirīgs ar to, ka sorbita koncentrācija ir robežās no 800 līdz 1.400g uz litru sākotnējās plazmas.Composition according to claim 1, characterized in that the sorbitol concentration ranges from 800 to 1.400 g per liter of the initial plasma. 3. Sastāvs saskaņā ar 2.p., atšķirīgs ar to, ka sorbita koncentrācija ir 1.300 g/1.3. A composition according to claim 2 wherein the sorbitol concentration is 1.300 g / l. 4. Sastāvs saskaņā ar jebkuru no 1. līdz 3. p., atšķirīgs ar to, ka saharozes koncentrācija ir robežās no 400 līdz 600 g/1.Composition according to any one of claims 1 to 3, characterized in that the sucrose concentration ranges from 400 to 600 g / l. 5. Sastāvs saskaņā ar 4.p., atšķirīgs ar to, ka saharozes koncentrācija ir 514 g/1.5. A composition according to claim 4, wherein the sucrose concentration is 514 g / l. 6. Sastāvs saskaņā ar jebkuru no 1. līdz 5. p., atšķirīgs ar to, ka kalcija glukonāta koncentrācija ir robežās no 3 līdz 5 mM.Composition according to any one of claims 1 to 5, characterized in that the calcium gluconate concentration ranges from 3 to 5 mM. 7. Sastāvs saskaņā ar 6.p., atšķirīgs ar to, ka kalcija glukonāta koncentrācija ir 4 mM.7. A composition according to claim 6, wherein the calcium gluconate concentration is 4 mM. 8. Sastāvs saskaņa ar jebkuru no 1. p. līdz 7. p., atšķirīgs ar to, ka trinātrija citrāta koncentrācija ir robežās no 8 līdz 25 mM.8. A composition as claimed in any one of claims 1 to 3. 7 to 7, wherein the trisodium citrate is present in a concentration ranging from 8 to 25 mM. 9. Sastāvs saskaņā ar 8. p., atšķirīgs ar to, ka trinātrija citrāta koncentrācija ir 15 mM.9. A composition according to claim 8, wherein the trisodium citrate has a concentration of 15 mM. 10. Sastāvs saskaņā ar jebkuru no 1. līdz 9. p., atšķirīgs ar to, ka lizīna un arginīna koncentrācijas ir robežās no 1 līdz 10 g/1.The composition according to any one of claims 1 to 9, wherein the concentrations of lysine and arginine are in the range of 1 to 10 g / l. 11. Sastāvs saskaņā ar 10.p., atšķirīgs ar to, ka lizīna un arginīna koncentrācijas ir 5 g/1.11. A composition according to claim 10, wherein the concentration of lysine and arginine is 5 g / l. 12. Asins plazmas pasterizācijas metode, atšķirīga ar to, ka pirms karsēšanas plazmai pievieno sastāvu saskaņā ar jebkuru no 1. p. līdz ll.p. un cukuru izdalīšanu no iepriekš minētā sastāva pēc karsēšanas stadijas ar dialīzi pret bufera šķīdumu, kurš satur trinātrija citrātu, kalcija glukonātu, nātrija hlorīdu, lizīnu un arginīnu.12. The method of plasma plasma pasteurisation, characterized in that a composition is added to the plasma prior to heating according to any one of claims 1 to 4. to ll.p. and separating the sugars from the above composition after the heating stage with dialysis against buffer solution containing trisodium citrate, calcium gluconate, sodium chloride, lysine and arginine. 13. Metode saskaņā ar 12. p., atšķirīga ar to, ka dialīzes bufera šķīdums satur 10 mM trinātrija citrāta, 4 mM kalcija glukonāta, 0,1 M nātrija hlorīda, 10 g/1 lizīna un 3 g/1 arginīna.13. The method of claim 12, wherein the dialysis buffer solution comprises 10 mM trisodium citrate, 4 mM calcium gluconate, 0.1 M sodium chloride, 10 g / l lysine, and 3 g / 1 arginine. 14. Metode saskaņā ar 12. p. vai 13. p., atšķirīga ar to, ka ir izmantojama, ja plazmas tilpums ir robežās no 1 litra līdz dažiem simtiem litru.14. The method of claim 12. or 13, characterized in that it is usable if the plasma volume ranges from 1 liter to a few hundred liters. 15. Totālā (kopējā) plazma terapijai, atšķirīga ar to, ka pastarizāciju veic, izmantojot metodi saskaņā ar jebkuru no 12. p. līdz 14. p.15. Total (total) plasma therapy, characterized in that the pasteurisation is performed by a method according to any one of claims 12 to 12. to p. 16. Krioprecipitētās plazmas supernatants terapijai, atšķirīgs ar to, ka tas tiek pastarizēts, izmantojot metodi saskaņā ar jebkuru no 12. p. līdz 14. p.A cryoprecipitated plasma supernatant for therapy, characterized in that it is pasteurized using a method according to any one of claims 12 to 12. to p. 17. Dzīvnieku izcelsmes plazma vai sērums, atšķirīgi ar to, ka tiek pastarizēti, izmantojot metodi saskaņā ar jebkuru no 12. p. līdz 14. p. 2 LV 10195 13. Metode saskaņā ar 12. p., atšķirīga ar to, ka dialīzes bufera šķīdums satur 10 mM trinātrija citrāta, 4 mM kalcija glukonāta, 0,1 M nātrija hlorīda, 10 g/1 lizīna un 3 g/1 arginīna. 14. Metode saskaņā ar 12. p. vai 13. p., atšķirīga ar to, ka ir izmantojama, ja plazmas tilpums ir robežās no 1 litra līdz dažiem simtiem litru. 15. Totālā (kopējā) plazma terapijai, atšķirīga ar to, ka pastarizāciju veic, izmantojot metodi saskaņā ar jebkuru no 12. p. līdz 14. p. 16. Krioprecipitētās plazmas supematants terapijai, atšķirīgs ar to, ka tas tiek pastarizēts, izmantojot metodi saskaņā ar jebkuru no 12. p. līdz 14. p.Plasma or germ of animal origin, other than being pasteurized by the method of any one of claims 12 to 12. to p. Method according to claim 12, characterized in that the dialysis buffer solution contains 10 mM trisodium citrate, 4 mM calcium gluconate, 0.1 M sodium chloride, 10 g / l lysine and 3 g / 1 arginine. . 14. The method of claim 12. or 13, characterized in that it is usable if the plasma volume ranges from 1 liter to a few hundred liters. 15. Total (total) plasma therapy, characterized in that the pasteurisation is performed by a method according to any one of claims 12 to 12. to p. A cryoprecipitated plasma supernatant for treatment, characterized in that it is pasteurized by the method of any one of claims 12 to 12. to p. 17. Dzīvnieku izcelsmes plazma vai serums, atšķirīgi ar to, ka tiek pastarizēti, izmantojot metodi saskaņā ar jebkuru no 12. p. līdz 14. p.Animal plasma or serum, differentiated in that it is pasted by the method of any one of claims 12 to 12. to p.
LVP-93-113A 1992-02-13 1993-02-10 Composition for stabilizing blood plasma during pasteurization and pasteurized plasma solution for therapeutic use LV10195B (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR9201604A FR2687317B1 (en) 1992-02-13 1992-02-13 COMPOSITION FOR STABILIZING BLOOD PLASMA DURING PASTEURIZATION AND PASTEURIZED PLASMATIC SOLUTION FOR THERAPEUTIC USE.

Publications (2)

Publication Number Publication Date
LV10195A LV10195A (en) 1994-10-20
LV10195B true LV10195B (en) 1995-04-20

Family

ID=9426597

Family Applications (1)

Application Number Title Priority Date Filing Date
LVP-93-113A LV10195B (en) 1992-02-13 1993-02-10 Composition for stabilizing blood plasma during pasteurization and pasteurized plasma solution for therapeutic use

Country Status (20)

Country Link
EP (1) EP0556096B1 (en)
JP (2) JP4010573B2 (en)
AT (1) ATE171074T1 (en)
BR (1) BR9300524A (en)
CA (1) CA2089446C (en)
CZ (1) CZ285573B6 (en)
DE (1) DE69321007T2 (en)
DK (1) DK0556096T3 (en)
EE (1) EE03091B1 (en)
ES (1) ES2121065T3 (en)
FI (1) FI103380B (en)
FR (1) FR2687317B1 (en)
HU (1) HU210026B (en)
LT (1) LT3226B (en)
LV (1) LV10195B (en)
NO (1) NO306532B1 (en)
PL (1) PL174098B1 (en)
RU (1) RU2112522C1 (en)
SK (1) SK280665B6 (en)
UA (1) UA27102C2 (en)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE9501189D0 (en) * 1995-03-31 1995-03-31 Pharmacia Ab Protein formulation
US5616159A (en) * 1995-04-14 1997-04-01 Corning Incorporated Method of forming high purity fused silica having high resistance to optical damage
US6619073B2 (en) 1996-03-05 2003-09-16 Corning Incorporated Method of increasing the initial transmittance of optical glass
US6114107A (en) * 1996-06-14 2000-09-05 Biostore New Zealand Limited Composition comprising raffinose, TMAO, sodium citrate and methods for the preservation of living tissues
US5827640A (en) * 1996-06-14 1998-10-27 Biostore New Zealand Limited Methods for the preservation of cells and tissues using trimethylamine oxide or betaine with raffinose or trehalose
US6037116A (en) * 1996-06-14 2000-03-14 Biostore New Zealand, Ltd. Compositions comprising betaine, sodium citrate and sodium chloride and methods for the preservation of biological materials
US6361933B1 (en) 1996-06-14 2002-03-26 Biostore New Zealand Limited Solutions for the preservation of tissues
US5879875A (en) * 1996-06-14 1999-03-09 Biostore New Zealand Compositions and methods for the preservation of living tissues
US5962213A (en) * 1996-06-14 1999-10-05 Biostore New Zealand Limited Compositions and methods for the preservation of living tissues
WO1997047192A1 (en) * 1996-06-14 1997-12-18 Biostore New Zealand Limited Compositions and methods for the preservation of living tissues
US6915665B2 (en) 2000-10-31 2005-07-12 Corning Incorporated Method of inducing transmission in optical lithography preforms
US20060019234A1 (en) * 2004-07-22 2006-01-26 Shanbrom Technologies, Llc Modern blood banking employing improved cell preservation composition
ES2264403B1 (en) * 2006-06-22 2007-11-01 Grifols S.A. HEMATIES SUSPENSION MEDIA.
DE102011056142A1 (en) * 2011-12-07 2013-06-13 Manfred Rüdinger Metabolizable salts and their use in diagnostics and therapy
RU2639446C1 (en) * 2016-11-23 2017-12-21 Федеральное государственное бюджетное образовательное учреждение высшего образования "Ярославский государственный медицинский университет" Министерства здравоохранения Российской Федерации Method for storage of blood plasma containing drugs with unstable phenolic hydroxiles

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3045153A1 (en) * 1980-11-29 1982-07-08 Behringwerke Ag, 3550 Marburg METHOD FOR THE PRODUCTION OF BLOOD COagulation FACTORS AND THE PREPARATION OF FACTORS IX AND X THEREFORE PRODUCED
DE3230849A1 (en) * 1982-08-19 1984-02-23 Behringwerke Ag, 3550 Marburg PASTEURIZED HUMAN FIBRINOGEN (HF) AND METHOD FOR THE PRODUCTION THEREOF
DE3237512A1 (en) * 1982-10-09 1984-04-12 Behringwerke Ag, 3550 Marburg METHOD FOR PASTEURIZING ANTIHAEMOPHILIC CRYOPRAEZIPITATE (AHK) AND ANTIHAEMOPHILE CRYOPRAECIPITATE PRODUCED THEREOF
US4470968A (en) * 1983-01-13 1984-09-11 Miles Laboratories, Inc. Pasteurized therapeutically active blood coagulation factor concentrates
JPS59134730A (en) * 1983-01-20 1984-08-02 Green Cross Corp:The Heat treatment of viii factor of blood clotting
DE3330770A1 (en) * 1983-08-26 1985-03-14 Behringwerke Ag, 3550 Marburg METHOD FOR PASTEURIZING HUMAN PLASMA
FR2650508A1 (en) * 1989-08-01 1991-02-08 Fondation Nale Transfusion San PASTEURIZED ADHESIVE FOR JOINING HUMAN OR ANIMAL TISSUES
FR2664165B1 (en) 1990-07-03 1992-10-16 Lille Transfusion Sanguine COMPOSITION FOR STABILIZING BLOOD PLASMA DURING PASTEURIZATION.

Also Published As

Publication number Publication date
FI103380B1 (en) 1999-06-30
EP0556096A1 (en) 1993-08-18
JPH0624997A (en) 1994-02-01
FI930630A0 (en) 1993-02-12
ES2121065T3 (en) 1998-11-16
NO930473L (en) 1993-08-16
CZ16193A3 (en) 1993-12-15
UA27102C2 (en) 2000-02-28
FI103380B (en) 1999-06-30
JP4472672B2 (en) 2010-06-02
DK0556096T3 (en) 1999-06-14
HU9300377D0 (en) 1993-04-28
PL174098B1 (en) 1998-06-30
FI930630A (en) 1993-08-14
NO306532B1 (en) 1999-11-22
JP4010573B2 (en) 2007-11-21
CA2089446A1 (en) 1993-08-14
RU2112522C1 (en) 1998-06-10
LV10195A (en) 1994-10-20
HUT63768A (en) 1993-10-28
NO930473D0 (en) 1993-02-11
LT3226B (en) 1995-04-25
CZ285573B6 (en) 1999-09-15
FR2687317A1 (en) 1993-08-20
EP0556096B1 (en) 1998-09-16
LTIP338A (en) 1994-08-25
JP2006306892A (en) 2006-11-09
BR9300524A (en) 1993-09-28
SK8293A3 (en) 1993-10-06
HU210026B (en) 1995-01-30
ATE171074T1 (en) 1998-10-15
EE03091B1 (en) 1998-06-15
SK280665B6 (en) 2000-05-16
DE69321007D1 (en) 1998-10-22
FR2687317B1 (en) 1995-06-23
PL297699A1 (en) 1994-01-10
DE69321007T2 (en) 1999-04-01
CA2089446C (en) 2006-04-18

Similar Documents

Publication Publication Date Title
JP4472672B2 (en) Plasma pasteurization method
DE3400413C2 (en)
DK156698B (en) PROCEDURE FOR PASTEURIZATION OF A MATERIAL CONTAINING A THERMALLALLY SENSITIVE, THERAPEUTIC ACTIVITY PROTEIN SELECTED WITH ALFA-L-ANTITRYPSIN, ANTITHROMOBIN-III, PRAEKALLIKRINE, ANTIHAEMOFILE FACTOR
US4876241A (en) Stabilization of biological and pharmaceutical products during thermal inactivation of viral and bacterial contaminants
JP3133338B2 (en) Methods for preparing virally safe biological compositions
US4562072A (en) Process for the pasteurization of antihemophilic cryoprecipitate (AHC) and antihemophilic cryoprecipitate prepared thereby
US4379085A (en) Heat stabilization of plasma proteins
AU622102B2 (en) A pharmaceutical containing tissue protein pp4, a process for the preparation of pp4 and for the pasteurization thereof, and the use of pp4
US4579735A (en) Process for the pasteurization of human residual plasma
EP0292003B1 (en) Stabilzation of biological and pharmaceutical products during inactivation of viral and bacterial contaminants
EP2695620B1 (en) Caprylate viral deactivation
AU772669B2 (en) Process for the inactivation of viruses
FI96918B (en) Composition for stabilizing blood plasma during pasteurization
AU608832B2 (en) Method of preparing highly purified alpha-1-proteinase inhibitor
JPH0530812B2 (en)
JPS58205495A (en) Heat stabilization of placental aspartate amino-peptidase