MXPA00001259A - A universally applicable blood plasma - Google Patents

Abstract

A universally applicable blood plasma obtainable by a process comprising the steps of mixing blood or blood plasma of blood groups A and B, optionally blood or blood plasma of blood group AB without admixing substantial amounts of blood or blood plasma derived from blood group O.

Description

BLOOD PLASMA APPLIED UNIVERSALLY Description of the invention: The present invention relates to a blood plasma applied universally as well as a process for preparing the same. Blood plasma is a widely used substitute for blood loss, for example, during operations or when severe hemorrhages occur after accidents. Since there are four main blood groups, at present the different plasmas are prepared to serve patients with different blood groups. Obviously, this is difficult since the four different blood plasma preparations have to be stored by the blood banks or respective blood centers in the hospital. In addition, it would be necessary to determine the blood group of the patient in need of a blood substitute. This delay can be critical in cases of emergency. Thus, the object of the invention is to provide a blood plasma preparation that can be applied universally to patients with different blood groups. The present invention provides a universally applicable blood plasma that can be obtained REF. : 32728 by mixing blood or blood plasma of blood groups A and B and optionally blood or blood plasma derived from blood group AB, without mixing substantial amounts of blood or blood plasma derived from blood group 0. The blood plasma preparation of the invention It is advantageous since you will not have the risk of incompatible plasma infusions that can cause severe adverse reactions that may even be lethal. Additionally, the blood plasma preparation of the invention can be located at the site where it is intended for use, ie, operating rooms and emergency rooms. Consequently, the end user can access this life-saving product immediately upon request. The respective end user does not have to wait until the ordered product of the blood centers is delivered. Currently the blood centers have to deliver a specific plasma of a blood group according to the blood group of the recipient. In a preferred embodiment of the invention, antibodies specific to the ABO blood groups of the blood plasma are neutralized and / or removed. A blood plasma preparation that is substantially free of group 0 fractions leads to a universally applicable blood plasma preparation. The blood plasma of the invention preferably comprises There are high amounts of plasma derived from donors having blood group A, average amounts of blood plasma derived from donors having blood group B and optionally low amounts of plasma derived from donors. who have blood group AB. The blood plasma of the invention is substantially free of blood plasma from donors having blood group 0. A most preferred embodiment of the present invention is a blood plasma comprising from 6 to 10 parts of blood plasma derived from donors having the blood group. blood A, 1 to 3 parts of blood plasma derived from donors having blood group B, and 0.0 to 1.5 parts of blood plasma derived from donors having blood group AB and substantially non-blood plasma derived from blood group O. In a highly preferred embodiment of the present invention blood plasma comprises from 7.5 to 8.5 parts of blood plasma derived from donors having blood group A, 1.5 to 2.5 parts of blood plasma derived from donors having blood group B, and optionally approximately 1 part of blood plasma derived from donors having blood group AB and substantially nothing Blood or blood plasma derived from blood group O.

Preferably, the blood plasma of the invention has been prepared by the pooled plasma derived from some donors. The pooled plasma has preferably been subjected to virus inactivation. Inactivation of virus can be carried out before mixing the blood or blood plasma of the different blood groups A, B and AB or after preparing the blood plasma of the present invention. For the inactivation of viruses, any methods of the art can be used, for example, inactivation of virus by irradiation with actinic radiation, pasteurization, treatment with solvent detergents or combinations of methods. A method well known in the art, for example, is the treatment with solvent detergent as described in EP-A-0 131 740, as well as the method according to O-A-94/17834 developed by Octopharma Ag, Switzerland. The blood plasma of the invention can be stored and delivered in any state known to those skilled in the art. The blood plasma may contain pharmaceutically acceptable adjuvants, such as stabilizers and anticoagulants. Preferably, the blood plasma of the invention is stored or delivered in a solid state, for example, in frozen form. In addition, it may be advantageous to store or deliver the blood plasma of the invention in lyophilized or spray-dried form. In the case that dry plasma is necessary, it can be easily dissolved in sterile water to infuse it to the patient. The ABO blood group-specific antibody titre of the blood plasma of the invention is preferably less than 16 for anti-A / anti-B IgM and 64 for anti-A / anti-B IgG. In a highly preferred embodiment the anti-A and anti-A antibody titer. anti-B is less than 8 for IgM and less than 32 for IgG. The process for preparing the blood plasma of the invention comprises the step of collecting blood or blood plasma from donors having blood groups A, B and optionally AB as well as neutralizing and / or removing antibodies. Blood is used as the starting material, plasma is produced from the pooled blood by methods known in the art. More than two thirds of all blood donors have free A and / or B substances in the plasma. These substances are almost identical to antigens A and B attached to the surface of red blood cells. By mixing appropriate amounts of blood or blood plasma of blood groups A, B and optionally AB, the anti-A and anti-B antibodies of the IgM and IgG subclasses are neutralized by binding two free A and / or B substances and / or stirring them during the additional process. Surprisingly, although the plasma of the present invention used as raw material contains residual red blood cells and complete complement systems there are no signs of complement activation during production or in the final product. According to the manufacturing process it is preferred that the mixing take place during the meeting of the plasma units at the beginning of the process combined with a process of cell removal and inactivation of complete viruses, preferably a treatment with solvent detergent. The final product can be used without limitation on the infusion rate in the total dose. The blood plasma of the invention prepared according to the process of the invention is advantageous since it is also active in coagulation. The present invention is better illustrated but not limited by the following example.

EXAMPLE 278 1 of fresh frozen plasma derived from blood group A, 68 1 from B and 34 1 from AB were mixed together and allowed to thaw. Sodium hydrogen phosphate dihydrate was added as a buffer to stabilize plasma proteins. After filtration through a membrane having a pore size of 1 μm, the viruses were inactivated from the fraction obtained by the solvent detergent method. After the removal of the virus inactivating agents, glycine was added to adjust the osmolarity. During the quality control the amounts of free anti-A and anti-B antibodies were tested. Such tests are well known in the art. The anti-A and anti-B antibody titre should be < 8 for IgM and < 32 IgG. It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.

Claims (10)

1. CLAIMS Having described the invention as above, the claim contained in claims 1 is claimed as property. A universally applicable blood plasma, characterized in that it is obtained by a process comprising the steps of mixing blood or blood plasma of blood groups A and B, optionally blood or blood plasma of blood group AB without mixing substantial amounts of blood or blood plasma derived from blood group O.
2. 2. The blood plasma according to claim 1, characterized in that the antibodies specific to ABO blood groups of blood plasma are neutralize and / or remove.
3. 3. The blood plasma according to claim 2, characterized in that it comprises high amounts of blood plasma derived from donors having blood group A, average blood plasma amounts derived from donors having blood group B, and optionally low amounts of blood. blood plasma derived from donors having blood group AB. Four . The blood plasma according to claim 3, characterized in that it comprises 6 to 10 parts of blood or blood plasma derived from donors having blood group A, 1 to 3 parts of blood or blood plasma derived from donors having blood group B , - 0.0 to 1.5 parts of blood or blood plasma derived from donors having blood group AB, substantially no blood or blood plasma derived from donors having blood group O. 5. Blood plasma according to any of the claims precedents characterized because it is in liquid, frozen or dry state. 6. The blood plasma according to claim 5, characterized in that it is in lyophilized or dried form, by spray. The blood or blood plasma according to any of the preceding claims, characterized in that it has pharmaceutically acceptable adjuvants, such as stabilizers and anticoagulants. 8. The blood or blood plasma according to any of the preceding claims, characterized in that the blood plasma was subjected to a treatment for virus inactivation. 9. A process for preparing the blood or blood plasma according to claim 1, characterized in that it comprises the steps of collecting blood or blood plasma from donors having blood groups A, and B, optionally mixing the blood or blood plasma of donors having AB blood group, optionally produce blood plasma or blood plasma pool, - neutralize and / or remove antibodies specific to ABO blood groups. 10. The process according to claim 9, characterized in that it also comprises the step of spray drying or lyophilizing the plasma.