MXPA06005897A - A universally applicable virus inactivated blood plasma produced from portions of non-caucasian plasma - Google Patents
A universally applicable virus inactivated blood plasma produced from portions of non-caucasian plasmaInfo
- Publication number
- MXPA06005897A MXPA06005897A MXPA/A/2006/005897A MXPA06005897A MXPA06005897A MX PA06005897 A MXPA06005897 A MX PA06005897A MX PA06005897 A MXPA06005897 A MX PA06005897A MX PA06005897 A MXPA06005897 A MX PA06005897A
- Authority
- MX
- Mexico
- Prior art keywords
- blood
- plasma
- blood plasma
- group
- donors
- Prior art date
Links
- 210000002381 Plasma Anatomy 0.000 title claims abstract description 89
- 241000700605 Viruses Species 0.000 title claims description 18
- 210000004369 Blood Anatomy 0.000 claims abstract description 87
- 239000008280 blood Substances 0.000 claims abstract description 85
- 102000004965 antibodies Human genes 0.000 claims description 21
- 108090001123 antibodies Proteins 0.000 claims description 21
- 235000009825 Annona senegalensis Nutrition 0.000 claims description 8
- 239000003599 detergent Substances 0.000 claims description 8
- 239000000203 mixture Substances 0.000 claims description 8
- 230000002779 inactivation Effects 0.000 claims description 6
- 239000002904 solvent Substances 0.000 claims description 6
- WWZKQHOCKIZLMA-UHFFFAOYSA-N Caprylic acid Chemical compound CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 claims description 4
- 238000003379 elimination reaction Methods 0.000 claims description 4
- 238000000034 method Methods 0.000 claims description 4
- 238000001728 nano-filtration Methods 0.000 claims description 4
- 238000009928 pasteurization Methods 0.000 claims description 4
- STCOOQWBFONSKY-UHFFFAOYSA-N Tributyl phosphate Chemical compound CCCCOP(=O)(OCCCC)OCCCC STCOOQWBFONSKY-UHFFFAOYSA-N 0.000 claims description 3
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 3
- 239000000194 fatty acid Substances 0.000 claims description 3
- 150000004665 fatty acids Chemical class 0.000 claims description 3
- 238000004519 manufacturing process Methods 0.000 claims description 3
- -1 polyoxyethylene Polymers 0.000 claims description 3
- 150000003839 salts Chemical class 0.000 claims description 3
- 239000011780 sodium chloride Substances 0.000 claims description 3
- 239000005635 Caprylic acid (CAS 124-07-2) Substances 0.000 claims description 2
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 2
- 229920004890 Triton X-100 Polymers 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 claims description 2
- 230000015271 coagulation Effects 0.000 claims description 2
- 238000005345 coagulation Methods 0.000 claims description 2
- 239000003814 drug Substances 0.000 claims description 2
- 229960002446 octanoic acid Drugs 0.000 claims description 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 2
- 150000008442 polyphenolic compounds Chemical class 0.000 claims description 2
- 235000013824 polyphenols Nutrition 0.000 claims description 2
- 229920000053 polysorbate 80 Polymers 0.000 claims description 2
- 206010037549 Purpura Diseases 0.000 claims 1
- 241001672981 Purpura Species 0.000 claims 1
- 230000000415 inactivating Effects 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 150000004668 long chain fatty acids Chemical class 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 230000001732 thrombotic Effects 0.000 claims 1
- 102000004851 Immunoglobulin G Human genes 0.000 description 7
- 102000004854 Immunoglobulin M Human genes 0.000 description 7
- 210000003743 Erythrocytes Anatomy 0.000 description 3
- 210000003324 RBC Anatomy 0.000 description 3
- 230000005540 biological transmission Effects 0.000 description 3
- 230000005591 charge neutralization Effects 0.000 description 3
- 239000004023 fresh frozen plasma Substances 0.000 description 3
- 230000001264 neutralization Effects 0.000 description 3
- 238000006386 neutralization reaction Methods 0.000 description 3
- 206010000206 ABO incompatibility Diseases 0.000 description 2
- 241000711549 Hepacivirus C Species 0.000 description 2
- 241000709721 Hepatovirus A Species 0.000 description 2
- 239000000427 antigen Substances 0.000 description 2
- 102000038129 antigens Human genes 0.000 description 2
- 108091007172 antigens Proteins 0.000 description 2
- 201000009910 diseases by infectious agent Diseases 0.000 description 2
- 230000002458 infectious Effects 0.000 description 2
- 238000010257 thawing Methods 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 102000015081 Blood Coagulation Factors Human genes 0.000 description 1
- 108010039209 Blood Coagulation Factors Proteins 0.000 description 1
- 210000000349 Chromosomes Anatomy 0.000 description 1
- 241000700721 Hepatitis B virus Species 0.000 description 1
- 241000713772 Human immunodeficiency virus 1 Species 0.000 description 1
- 241000713340 Human immunodeficiency virus 2 Species 0.000 description 1
- 241000484121 Human parvovirus Species 0.000 description 1
- 241000125945 Protoparvovirus Species 0.000 description 1
- 206010047461 Viral infection Diseases 0.000 description 1
- 208000001756 Virus Disease Diseases 0.000 description 1
- 238000004166 bioassay Methods 0.000 description 1
- 239000003114 blood coagulation factor Substances 0.000 description 1
- 210000004027 cells Anatomy 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 230000000875 corresponding Effects 0.000 description 1
- 230000029036 donor selection Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 230000001900 immune effect Effects 0.000 description 1
- 244000045947 parasites Species 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 201000007023 thrombotic thrombocytopenic purpura Diseases 0.000 description 1
- 230000017613 viral reproduction Effects 0.000 description 1
Abstract
A blood plasma for human use pooled from donors which belong to 10%or more to a non-Caucasian population, the plasma obtainable by mixing blood or blood plasma of blood groups A and B, optionallyAB without admixing substantial amounts of blood or blood plasma of blood group 0 characterized in that four to eight parts of blood or blood plasma from donors having the blood group A, more than three parts to seven parts of blood or blood plasma from donors having the blood group B, zero to two parts of blood or blood plasma from donors having the blood group AB.
Description
BLOOD PLASMA INACTIVATED IN VIRUSES, UNIVERSALLY APPLICABLE, PRODUCED FROM PORTIONS OF PLASMA NO CAUC SICO
FIELD OF THE INVENTION The present invention relates to a combined blood plasma from donors that are substantially non-Caucasian, a pharmaceutical preparation comprising the blood plasma of the invention and the use of the blood plasma of the invention for the manufacture of a medicament. BACKGROUND OF THE INVENTION Blood groups and the inherent inter-individual differences in human blood were discovered by Karl Landsteiner. The ABO blood group system comprises 4 major phenotypes; 0, A, B and AB, the phenotype being governed by the codominant alleles at the ABO locus on chromosome 9. The transfusion of identical or ABO-compatible plasma, such as FFP of specific blood groups, is an effective treatment and in General well tolerated of various types of complex deficiencies or isolated deficiencies in the coagulation factor, in thrombotic thrombocytopenic purpura, and in large volume, repeated plasma exchange. However, the
Ref. -.173007 plasma transfusion in principle implies some risk of adverse events among the recipients, which include the transmission of infectious and non-infectious diseases. Non-infectious adverse events typically occur when immunological incompatibility between, for example, the red blood cells of the transfused donor and the recipient's antibodies produce accelerated destruction of the transfused cells. According to Landsteiner's law, any human individual has antibodies in plasma if the corresponding antigen is absent from red blood cells. For example, when infusing plasma from a donor of group A, to a patient of group B, the anti-B antibodies of the donor plasma will react with and lead to the destruction of the patient's red blood cells. Similarly, plasma from a group B donor, containing anti-A antibodies, is incompatible with a patient of blood group A; and plasma from a group 0 donor, containing anti-A and anti-B antibodies, is incompatible with a patient who has blood in group A, B or AB. Therefore, blood types must be matched to avoid a reaction based on ABO incompatibility. In addition to noninfectious adverse events, many infectious agents, including viruses, bacteria and parasites, can be transmitted through blood transfusion. Well-recognized viruses include hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus type 1 and 2 (HIV-l / 2), and the human parvovirus (PV). The risk of transmission of viral infections is minimized by the introduction of donor selection and new testing procedures, and in particular, by introducing virus inactivation and / or virus elimination procedures. Such methods include inactivation of the virus by treatment with solvent and detergent (European Patent EP-A-0, 131, 740), irradiation and pasteurization, or elimination of the virus by nanofiltration. Human plasma treated with solvent detergent, with specific blood groups, such as Octaplas® of blood groups A, B, 0, or AB (Octapharma AG Switzerland), was already developed as an alternative to FFP in order to prevent transmission of the virus. Plasma universally applicable in principle can be obtained by using only AB plasma, which does not contain anti-A or anti-B antibodies (IgM and IgG), so it is compatible with any patient notwithstanding its blood group. However, the frequency of AB donors (4%) is limited. A suitable plasma for universal transfusion is obtained, if the anti-A and / or anti-B antibodies coming from the donors of blood group B and A, respectively, they are eliminated and / or neutralized by optimal mixing of the plasma with the different blood groups. Such neutralization of the antibodies was already described (WO-A-99/07390) by mixing 6 to 10 parts of blood or blood plasma of blood group A, 1 to 3 parts of blood or blood plasma of blood group B, and optionally 0 to 1.5 parts of blood or blood plasma of blood group AB, without mixing substantial amounts of blood or blood plasma derived from blood of group 0. All human races in principle share the same blood system, although the frequency of the four main blood groups ABO, varies in populations throughout the world. By measuring the titers of anti-A and anti-B antibodies, it was surprisingly found that not only the frequency of the ABO blood groups, but also the titers of the blood group-specific antibodies differ among different ethnic groups. In Caucasians, in general, anti-A antibody titers in subjects of group B and group O tend to be higher than anti-B titers in subjects of group A and group O. On the contrary, in people with a non-Caucasian background, such as African-Americans,. Hispanics or Native Americans, the anti-B titles are almost as high as those of anti-B. Consequently, by mixing Caucasian plasma with a considerable portion of non-Caucasian origin at the aforementioned proportions, optimal neutralization of blood group-specific antibodies was found. For example, by mixing 7 parts of blood group A plasma with 3 parts of blood group B plasma, a considerable portion of which was collected from non-Caucasian donors were found in the combined plasma mixture, high anti-B titers. , of the IgM and IgG type. DETAILED DESCRIPTION OF THE INVENTION One objective of the invention was to develop an inactivated blood plasma in additional applicable virus, which is produced during the optimal mixing of blood plasma of different blood groups, obtained from blood or plasma of Caucasian origin and portions of donors. not Caucasians, such as donors of African-American, Hispanic and Native American origin, facilitating an optimal neutralization of specific blood group antibodies in the mixture. This objective is solved by a blood plasma for combined human use of donors belonging to 10%. or more to a non-Caucasian population, the plasma is obtainable by mixing blood or blood plasma of blood groups A and B, optionally AB without mixing substantial amounts of blood or blood plasma of blood group 0, comprising: four to eight parts of blood or blood plasma from donors having blood group A, more than three to seven parts of blood or blood plasma from donors having blood group B, - zero to two parts of blood or blood plasma from donors having blood blood group AB. Fractions of blood group O may be present in the plasma of the invention, as long as these fractions do not introduce antibodies that substantially exceed the total concentration of blood group A or -B antigen. In the blood plasma product of the invention, the ABO blood group-specific antibodies are essentially. neutralized by free blood group substances by an optimal mixture of different blood groups, and therefore, this plasma can be transfused notwithstanding the ABO blood group of the patient. Therefore, the blood plasma of the invention also reduces the risk of transfusion-related infections, as well as fatalities related to ABO incompatibility. In another embodiment of the invention, the blood plasma mixture is composed of: five to six parts of blood or blood plasma derived from donors with blood group A, four to five parts of blood or blood plasma derived from donors with blood group B, zero to one part of blood or blood plasma derived from donors with blood group AB, and - substantially no plasma or blood plasma derived from donors with group blood O. The ABO blood group specific antibody titer of the blood plasma of the invention is in particular less than 16 for anti-A and anti-B IgM antibodies, and less than 64 ^ for anti-A and IgG antibodies. anti-B In yet another mixture of the blood plasma of the invention, the anti-A and anti-B IgM antibody titre was less than 8, and the anti-A and anti-B IgG antibody titre is less than 32, using known assays for a person skilled in the art and described in the European Pharmacopoeia (Indirect Test of Coombs). Preferably, the blood plasma of the invention is inactivated by the method of European Patent EP-A-131740, known as the treatment with solvent / detergent, irradiation, pasteurization and / or nanofiltration. A typical solvent / detergent treatment is for example the use of detergents such as oxyethylated polyphenols, such as Triton-X-100, and / or polyoxyethylene derivatives of fatty acids such as Tween 80 and tri-N-butylphosphate (T? BP). , or combinations thereof. Also fatty acids of medium to long chain or salts thereof, saturated and unsaturated, preferably caprylic acid or its salts, can be used for inactivation in viruses. Other methods are irradiation, pasteurization or nanofiltration. All these methods are known to the person skilled in the art. Preferably, the blood plasma of the invention is frozen or lyophilized. The blood plasma of the invention shows coagulation activities comparable to fresh frozen plasma. The present invention is further illustrated by the following example. Example 1 190 kg of fresh frozen plasma of blood group A, 156 kg of blood group B plasma, and 34 kg of blood group AB plasma, all obtained in a considerable portion of non-Caucasian donors, are mixed after thawing at + 37 ° C. The obtained plasma mixture is inactivated in viruses by the use of solvent and detergent method. After the elimination of the inactivation reagents in virus and lyophilization, the amount of free anti-A and anti-B antibodies of the IgM and IgG type is measured. The anti-A and anti-B antibody titer of the IgM type is less than 8, and the anti-A and anti-B antibody titer of the IgG type is less than 32.
Example 2 205 kg of fresh frozen plasma of blood group A, and 137 kg of blood group B plasma, all obtained in a considerable portion of non-Caucasian donors, are mixed after thawing at + 37 ° C. The same procedure as in Example 1 was used. The anti-A and anti-B antibodies of the IgM type are less than 8 and the IgG type are less than 32. It is noted that in relation to this date, the best method known to carry out the said invention is that which is clear from the present description of the invention.
Claims (11)
1. A blood plasma for human use, combined from donors belonging to 10% or more of them to a non-Caucasian population, the plasma is obtainable by mixing blood or blood plasma of blood groups A and B, optionally AB without mixing the blood or blood plasma of blood group 0, characterized in that: five to six parts of blood or blood plasma is from donors having blood group A, more than four parts to five parts of blood or blood plasma is from donors who have the blood blood group B, zero to one part of blood or blood plasma is from donors who have blood group
AB. 2. The blood plasma according to claim 1, characterized in that the viruses are inactivated by any method of virus inactivation or elimination.
3. The blood plasma according to claim 2, characterized in that the blood plasma was inactivated by treatment with solvent / detergent, irradiation, pasteurization and / or nanofiltration.
4. The blood plasma according to claim 3, characterized in that the inactivation of the virus was performed by the use of detergents such as oxyethylated polyphenols, such as Triton-X-100 and / or polyoxyethylene derivatives of fatty acids such as Tween 80 and tri-N-butyl phosphate (TNBP), or combinations thereof.
5. The blood plasma according to claim 3, characterized in that the virus is inactivated by treatment with long chain fatty acids, such as caprylic acid or the respective salts.
6. The blood plasma according to any of the preceding claims, characterized in that it is substantially free of virus inactivating agents. The blood plasma according to any of the preceding claims, characterized in that it has an ABO blood group-specific antibody titre, less than 16 for anti-A and anti-B IgM antibodies, and less than 64 for IgG antibodies anti-A and anti-B. 8. The blood plasma according to any of the preceding claims, characterized in that it is in liquid, frozen, dehydrated or lyophilized form. 9. A pharmaceutical composition, characterized in that it comprises blood plasma according to any of claims 1 to 8. The use of blood plasma according to any of the preceding claims for the manufacture of a medicament for the treatment of factor deficiencies. of coagulation, thrombotic purpura and in repeated exchange of large volumes of plasma. 11. A process characterized in that it is for the manufacture of blood plasma according to any of claims 1 to 8, by mixing: - four to eight parts of blood or blood plasma from donors having blood group A, plus from three parts to seven parts of blood or blood plasma from donors having blood group B, zero to two parts of blood or blood plasma from donors having blood group AB.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP03029359.1 | 2003-12-19 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MXPA06005897A true MXPA06005897A (en) | 2007-04-20 |
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