Press release – 24, June 2013

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Pathogen reduction systems for fresh frozen plasma (FFP) such as the Methylene blue (MB)/light-based THERAFLEX MB-Plasma system (Macopharma) were developed to increase the viral safety of plasma transfusions. However, FFP may also become contaminated with bacteria in rare cases. The Blueflex filter which reduces the concentration of MB and its derivatives in the treated plasma1 by up to 90%, is an integral part of the THERAFLEX MB-Plasma system.

Recent investigations using the THERAFLEX MB-Plasma system have shown that bacterial contamination of several transfusion-relevant species can be efficiently reduced. K. pneumoniae or S. epidermidis e.g. were reduced by at least ≥ 4.7 log steps.2 This was achieved after both filtration steps (Plasma filtration with the PLAS4 filter and MB-treated plasma filtration with the Blueflex filter) in the treated plasma from whole blood. A complementary study that has been presented during the recent 23rd Regional Congress of the ISBT, held in Amsterdam, The Netherlands, from June 2 – 5, 2013, revealed that bacterial spores of B. subtilis were reduced by more than 4.7 log steps due to Blueflex filtration alone3.

The overall reduction capacity of the THERAFLEX MB-Plasma system is expected to be sufficient to prevent transfusion-transmitted bacterial infections, taking into account the concentration of bacteria normally present in contaminated therapeutic plasma.

With our THERAFLEX MB-Plasma procedure we have already shown a pivotal contribution to viral and parasitical safety of therapeutic plasma for more than a decade. We are proud that these new results extend the pathogen protection range also to bacteria and bacterial spores.” stated Dr. Stefan Reichenberg, Macopharma’s Scientific Marketing Manager.

About Macopharma

Macopharma SA (« Macopharma ») is an innovator in global healthcare with expertise in the fields of transfusion and infusion. 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 70 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, efficacy, 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.

Verpoort,T., Chollet,S., Héron,C., Lebrun,F., Goudaliez,F., Walker,W.H., and Reichenberg,S. 2003. Filtration of Methylene Blue and Photoproducts after Photodynamic Treatment of Plasma using BLUEFLEX. VIII European Congress of the International Society of Blood Transfusion, Istanbul (Abstr.)
Gravemann,U., Reichenberg,S., Sumian,C., Lambrecht,B., and Seltsam,A. 2012. Elimination of Bacteria from Fresh Frozen Plasma with the THERAFLEX MB-Plasma System. Transfusion 52:10A-284A (Abstr.)
Gravemann,U., Reichenberg,S., Sumian,C., and Seltsam,A. 2013. The Blueflex filter of the THERAFLEX MB-Plasma system (Macopharma) efficiently removes different bacteria species from therapeutic plasma.

Macopharma would like to thank our customers, distributors and partners all around the world that have strongly shown a big interest for all our products, particularly pathogen inactivation technologies during the ISBT congress 2013 in Amsterdam.

Especially Macopharma’s symposium related to blood safety drew a lot of attention.