Tourcoing — December 19, 2014 - A “Letter to the editor” from the Catalonian blood centre in Spain entitled “Allergic and anaphylactic reactions to methylene-blue-treated plasma in Catalonia in the period 2008-2013” was recently published in « Blood Transfusion ».

In Spain, nearly 1.4 million units of MB-treated plasma units were transfused since 1997 without any reported serious adverse events.

The blood centre of Catalonia which is producing exclusively MB-treated plasma stated that for the period 2008-2013, total allergic reactions have decreased and the percentage of severe reactions vs total reactions was stable during the study period. The rate of severe reactions to plasma was always below 1 per 4700 units transfused.

Methylene Blue has been demonstrated to be a safe and effective alternative to other dyes like Isosulfan blue or patent blue violet (used in lymphangiography and sentinel node biopsy as a dye to color lymph vessels) and rarely evokes an allergic response.

Finally, 2008-2013 haemovigilance data from the Catalonian region do not appear to be consistent with the French findings (high rate of allergic reactions notified by the French regulatory body AFSSAPS causing the withdrawal of the MB-treated plasma from the list of authorised blood components from March 2012).

The fully version of the article is available on the following link:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4212051/

Le 20 novembre 2014, a eu lieu, durant le congrès de la SFVTT à Marseille,  le symposium Macopharma traitant de la technologie THERAFLEX MB-Plasma, procédure photodynamique utilisant le Bleu de Méthylène et la lumière visible pour l’inactivation des pathogènes dans le plasma.

Ont participé à ce symposium une centaine de personnes dont M. Philippe Renaudier le président du comité scientifique de la SFVTT, M. Nicolas Ferry, directeur BIOVAC à l’ANSM, plusieurs personnes de l’EFS ainsi qu’un nombre important de médecins hémovigilants.

Durant ce symposium, Macopharma a partagé avec la communauté scientifique les diverses études et publications au niveau européen qui traitent du plasma BM.

Pour rappel, l’augmentation du nombre de déclarations d’évènements indésirables de type allergiques et imputables à la transfusion de plasma viro atténué par le bleu de méthylène a contribué au retrait de ce produit en France, le 1er mars 2012.

 Suite à cette décision de retrait, Macopharma a concentré ses efforts sur les études européennes justifiant l’innocuité du produit. La plupart des études qui ont été citées dans ce symposium relèvent d’un plasma thérapeutique issu de sang total et utilisant un nouveau comprimé de bleu de méthylène, présentant moins d’impuretés (à savoir moins de métaux lourds, pouvant être à l’origine de certaines allergies).

Durant ce symposium, le Pr Olivier Garraud, Adjoint au directeur et chargé des affaires internationales à Institut National de la Transfusion Sanguine, et co-directeur de l’EA 3064 à l’Université de Lyon/Saint-Etienne,  a présenté les résultats d’une étude rétrospective régionale qui s’est déroulée sur une durée de 12 ans, concernant les quatre types de plasma : SD, Sécurisé par Quarantaine, Amotosalen et Bleu de Méthylène.

Le Pr Garraud a également évoqué les grandes tendances 2015 du plasma en France et en Europe, dans un contexte rapidement évolutif, à l’image de l’évolution du statut du plasma SD.

Le 2nd sujet de ce symposium a été présenté par le Dr Hervé Gouëzec, Praticien Hospitalier et Correspondant d’hémovigilance au  CHU de Rennes.  Le Dr Gouëzec a exposé son avis personnel quant au plasma BM, en tant qu’utilisateur et hémovigilant.

Les modérateurs, à savoir le Pr Jean-Pierre Allain (Professeur émérite en médecine transfusionnelle au département d’hématologie de l’Université de Cambridge au Royaume Uni), le Professeur Paul Coppo (Professeur d’hématologie et coordinateur du Centre de Référence des Micro-angiopathies Trombotiques à l’hôpital Saint Antoine à Paris) et le Pr Olivier Garraud ont également contribué au succès de ce symposium grâce à la qualité des questions posées et aux différents échanges et retour d’expériences.

Un grand et dernier merci au président de la SFVTT Docteur Bernard Lassale, au Docteur Phillippe Renaudier, aux organisateurs de la SFVTT, aux présentateurs, modérateurs et participants au symposium THERAFLEX MB-Plasma !

Retrouvez Macopharma au prochain congrès de la SFVTT à Marseille du 19 au 21 Novembre 2014, et venez assister à son symposium sur la technologie
THERAFLEX MB-Plasma.

Pour plus de détails, cliquez sur l’image

Tourcoing — October 29, 2014 - Macopharma is pleased to inform you that a current article from the Blood Centre of Galicia, Santiago de Compostela, Spain, entitledIn Vitro evaluation of platelet concentrates suspended in additive solution, and treated for pathogen REDUCTION: Effects of clumping formation. has been recently published in the journal “Blood Transfusion”.

The aim of this study was to analyse the relationship between the occurrence of clumping and their effect on in vitro quality of platelet concentrates suspended in additive solution.

No significant difference was found throughout storage between the groups. The LDH levels increased in both groups, but this increase was higher in the test group at the last day of testing, without significant difference on day 2. In contrast, pH values on day 2 were significantly different between test and control group. Platelet derived cytokines increased comparably during storage.

The authors conclude that:

In summary, with the PAS-E containing potassium and magnesium, glycolysis activity decreases, glucose is maintained within appropriate levels until the end of extended storage and there is a platelet activation decrease.

 The presence of « non-compacted » clumps in PCs did not appear to significantly affect the in-vitro quality of platelets suspended in plasma and PAS-E and treated with PRT.”

 

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.

www.macopharma.com

About Platelet Additive Solution SSP+

Platelet concentrates (PCs) are notably used for the prevention and treatment of bleeding complications in thrombocytopenic patients. Therefore platelet quality, function, storage stability, morphology and cell integrity needs to be well maintained during processing and storage. Platelet additive solution SSP+ (PAS III-E generation) is recognised as the most suitable additive solution on the market that helps standardise platelet concentrates and improves storage conditions for up to 7 days. SSP+ is compatible with manual methods and Backlab technologies for the preparation of PCs from buffy-coat and has been validated to be used with all Pathogen Reduction technologies.

www.bloodsafety.macopharma.com

Tourcoing — October 8, 2014 - Macopharma is pleased to inform you that a current article from the Coordinating Haemovigilance Centre, Athens, Greece, entitled “Haemovigilance data on the use of methylene blue virally inactivated fresh frozen plasma with the Theraflex MB-Plasma System in comparison to quarantine plasma: 11years’ experience.” has been recently published in the journal “Transfusion Medicine”1.

The aim of this study was to analyse cumulative haemovigilance data in order to compare the two secured therapeutic plasmas that have been in use for more than 11 years in Greece – methylene blue-treated fresh frozen plasma (MB-FFP) and quarantine fresh frozen plasma (Q-FFP) – regarding safety and adverse events.

The incidence of adverse events was higher with Q-FFP (1:3 620) than MB-FFP (1: 24 593) by a factor of 6.79. Allergic adverse events were also commoner with Q-FFP (1: 7 489) than with MB-FFP (1:24 593), by a factor of 3.28. All adverse reactions experienced by the MB plasma recipients were considered to be mild.

The authors conclude that “haemovigilance over 11years has demonstrated the long-term safety of MB-FFP in comparison to untreated quarantine FFP. In addition to lowering the adverse event rate, implementing the system on a national scale in at-risk countries would presumably reduce the transmission of severe viral infections including emerging infectious diseases by transfusion.”

 

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.

www.macopharma.com

 

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.

www.bloodsafety.macopharma.com

 

1.   Politis C, Kavallierou L, Hantziara S, Parara M, Zervou E, Katsarou O, Hatzitaki M, Fountouli P, Gioka A, Tzioura K, Koumarianos S, Asariotou M, Richardson C. Haemovigilance data on the use of methylene blue virally inactivated fresh frozen plasma with the Theraflex MB-Plasma System in comparison to quarantine plasma: 11 years’ experience. Transfus Med 2014.

We look forward to representing to the Americas and many visitors from multiple international countries the many automation options Macopharma has to offer, in addition to the cord blood and whole blood collection and processing solutions we provide to over 70 countries worldwide.

Please come visit us on our booth number 803. Share with us your needs and let us know what solutions we can provide to you today, and tomorrow.

We will be delighted to welcome you at booth 57 during the DGTI congress.

Before the end of this year, Macopharma will participate to several congresses worldwide. Please check our events list and visit our booths.

This will be the perfect opportunity for professionals in the transfusion medicine field to come together to hear and learn about the latest developments in transfusion medicine from respected international and local speakers. MACOPHARMA will of course be present!

During the opening ceremony, MACOPHARMA will welcome customers and visitors on its booth n °402. They will therefore discover our booth with a resolutely different and dynamic design.

MACOPHARMA will have the pleasure to welcome some choosen customers to a multi-cultural GALA DINNER on Monday the 2nd from 8.00 pm to discover the korean food, culture and hospitality!

Tourcoing — April 18, 2014 — Macopharma announced today that it is working with international CRO (contract research organization) SynteractHCR to initiate the fourth hospital in a European country for the prospective non-interventional study for THERAFLEX MB-Plasma.

 The aim of this post marketing surveillance study is to collect, during a period of at least one year, adverse events related to MB-treated plasma transfusions in four key European hospitals in Belgium, UK, Spain and Greece where MB-treated plasma is in routine use. 

As of April 18, 2014, five patients have been enrolled at two sites in Spain and Belgium. The first patient was enrolled in Spain in November 2013.

 “This Macopharma milestone marks an important step in our effort to collect consistent European haemovigilance data on pathogen-inactivated plasma,” Macopharma Clinical Research Manager Dr. Ignacio Alvarez, said. “Plasma transfusion is known to present some allergic reactions mostly linked to the composition of the plasma itself.  MB-treatment is a very safe process and the implementation of this prospective study in patients aims to underscore the safety of the THERAFLEX MB-Plasma technology.”

 

About Macopharma

 Macopharma SA (“Macopharma”) (www.macopharma.com) 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 its 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.

 www.bloodsafety.macopharma.com

 

About SynteractHCR

 SynteractHCR  is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. SynteractHCR has conducted Phase I-IV studies on six continents and in more than 50 countries, offering expertise across multiple therapeutic areas and with notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications. With its “Shared Work – Shared Vision” philosophy and ICD+ approach, SynteractHCR provides customized services collaboratively and cost effectively, ensuring on-time delivery of quality data so clients get to decision points faster.

  www.SynteractHCR.com