Bacteria retention and robust virus inactivation in lipaemic plasma with the THERAFLEX MB-Plasma technology
Tourcoing — April 22, 2015 - Macopharma is pleased to inform you that a current article, entitled “Challenge study of the pathogen reduction capacity of the THERAFLEX MB-Plasma technology” has been recently published in the journal “Vox Sanguinis” 1.
Aim of the study was to investigate the bacterial reduction capacity of the THERAFLEX MB-Plasma treatment process. Moreover, the virus inactivation capacity in lipaemic plasma was explored.
The filtration steps of the procedure resulted in efficient bacteria reduction of transfusion-relevant strains like Staphylococcus epidermidis, Staphylococcus aureus, Escherichia coli, Bacillus cereus and Klebsiella pneumoniae ≥ 4.8 logs i.e. to the limit of detection (LOD). In addition, bacterial spores of Bacillus subtilis were eliminated. The overall reduction capacity of the THERAFLEX MB-Plasma technology is expected to be sufficient to prevent transfusion-transmitted bacterial infections, taking into account the concentration of bacteria normally present in contaminated therapeutic plasma.
HIV-1 and model viruses for HBV and HCV were efficiently inactivated by the MB/ light procedure independent of the degree of lipaemia. Its virus inactivation capacity is sufficient to compensate for reduced light transparency caused by intense lipaemia. This underlines the robustness of the system for natural plasma variation.
Macopharma SA (“Macopharma”) (www.macopharma.com) is an innovator in global healthcare with expertise in the fields of transfusion, infusion and biotherapy. The company has become the largest supplier of in-line leucodepletion filtration sets in Europe.
It is expanding its efforts in the fields of respiratory masks and cellular therapy by developing products for cell expansion, in addition to cell/organ processing and freezing. Headquartered in the Lille metropolitan area (France), Macopharma has four manufacturing facilities in Europe and their products are sold into more than 100 countries worldwide. One of Macopharma’s aims is to provide a comprehensive range for the pathogen reduction of infectious agents in plasma, platelets and red cells. This is aligned with Macopharma’s product development strategy of the continuous quest, through partnerships, for improved safety, efficiency, and quality of transfusion, infusion, masks and cellular therapy.
About THERAFLEX MB-Plasma
The THERAFLEX MB-Plasma System has a Class III CE Mark (available for sale in countries where the CE mark is accepted) and is not currently available for sale in the United States. It is a user-friendly in-house treatment for single units of plasma. The GMP-conforming procedure is adapted for the inactivation of FFP from aphaeresis or whole blood plasma. The MB plasma system uses a combination of a membrane filter Plasmaflex PLAS4, (which removes residual leucocytes, red cells, platelets and aggregates, intra-cellular viruses and minimises the amount of microvesicles and microparticles), a dry Methylene Blue pill, visible light and a Blueflex Methylene Blue removal filter.
See www.bloodsafety.macopharma.com, for more information.
1Reichenberg S, Gravemann U, Sumian C, Seltsam A. Challenge study of the pathogen reduction capacity of the THERAFLEX MB-Plasma technology. Vox Sanguinis 2015: DOI: 10.1111/vox.12257