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Blood bag system and process for the inactivation of pathogens in platelet concentrates by use of the blood bag system

a blood bag and platelet concentrate technology, applied in the field of blood bag system and process for inactivation of pathogens in platelet concentrates, can solve the problems of infectivity at the recipient, difficulty in ensuring the required degree of absence of pathogens in blood products, and the inability of the sengewald bag used in the method to avoid dead areas

Inactive Publication Date: 2010-06-03
MACO PHARMA SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0016]The blood bag system comprises either one bag for irradiation with UV light and storage of a suspended PC, wherein the irradiation bag forms at the same time the storage bag, or comprises a first bag for irradiation (irradiation bag) with UV light and a second bag (storage bag) for storage wherein in each of the different blood bag systems the irradiated suspended PC can be stored for up to 10 clays without clinically significant reduction of the therapeutic quality.
[0023]According to a preferred embodiment of the invention, the irradiation bag has one or more inlet tubes for filling the PC into the irradiation bag and optionally one or more outlet tubes for discharging the irradiated PC into the storage bag. The irradiation bag is further provided with means for preventing fluid access into the inlet and / or outlet tubes such that no dead area is formed inside the bag.
[0033]However, other suitable platelet storage solutions may also be used, which replace the plasma for storage. Optimal storage of PC in storage bag is characterized by in vitro parameters like swirling, pH, osmotic stability and aggregation, as described in table 1. With the platelet storage solution UV-irradiation, mixing of the partially plasma exchanged PC by agitation of the irradiation bag and storage in the storage bag is optimal.

Problems solved by technology

Despite intense testing, it is difficult to assure the required degree of absence of pathogens in blood products.
Pathogens exist in human blood donations and may lead to infectivity at the recipient.
The Sengewald bag used in the method is not designed to avoid dead areas during the irradiation.

Method used

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  • Blood bag system and process for the inactivation of pathogens in platelet concentrates by use of the blood bag system
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  • Blood bag system and process for the inactivation of pathogens in platelet concentrates by use of the blood bag system

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Embodiment Construction

[0016]The blood bag system comprises either one bag for irradiation with UV light and storage of a suspended PC, wherein the irradiation bag forms at the same time the storage bag, or comprises a first bag for irradiation (irradiation bag) with UV light and a second bag (storage bag) for storage wherein in each of the different blood bag systems the irradiated suspended PC can be stored for up to 10 clays without clinically significant reduction of the therapeutic quality.

[0017]According to a preferred embodiment the blood bag system according to the invention comprises a leucodepletion filter for leucodepletion of the inlet stream of non-irradiated PC. The leucodepletion filter for above purpose is preferably incorporated in the inlet tubing of the irradiation bag.

[0018]The irradiation bag is made from an UV-transparent plastic material. Suitable polymer materials are polyolefins and ethylene vinyl acetate (EVA), extruded or calendered to wall thicknesses of 0.8 mm or less, in part...

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Abstract

The present invention relates to a blood bag system, a method for its manufacture, and a process for reducing pathogens and leucocytes in biological fluids in particular in therapeutic quantities of platelet concentrates (PC) contained in the blood bag system, using UV-light and agitation, wherein part of the plasma of the PC is optionally exchanged against a platelet additive solution.

Description

[0001]The present invention relates to a blood bag system, a method for its manufacture and a process for reducing pathogens and leucocytes in biological fluids in particular in therapeutic quantities of platelet concentrates (PC).[0002]The presence of potentially pathogenic materials such as viruses and / or bacteria in biological fluids is of great concern for many protocols, particularly those involving the processing of blood and / or blood components, e.g. to obtain transfusion products to be administered to patients. A number of diagnostic tests are developed and routinely used to assure viral and bacterial safety of blood products. Despite intense testing, it is difficult to assure the required degree of absence of pathogens in blood products. Pathogens exist in human blood donations and may lead to infectivity at the recipient. It is therefore required to find and use save procedures which allow the destruction and / or removal of such pathogens in human blood or blood products.[0...

Claims

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Application Information

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IPC IPC(8): A61K41/00A61J1/10B65B3/04
CPCA61J1/10A61J1/12A61K41/0019A61L2/0011A61M1/0218A61M1/3681A61M2205/053A61M2205/75A61M1/0209A61M1/0222A61M1/0231A61K41/17A61L2/0047A61L2202/22A61L2202/23A61M1/0272A61M2207/00B65B7/02B65B55/08B65B55/16
Inventor WALKER, WOLFRAM HUBERTTOLKSDORF, FRANKVERPOORT, THIERRYGOUDALIEZ, FRANCIS
Owner MACO PHARMA SA
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