Il y a quelques semaines, l’ANSM a demandé à la Société Stérylène de suspendre temporairement ses activités de stérilisation par oxyde d’éthylène, des non-conformités règlementaires ayant été relevées lors d’une inspection de routine.
Cette suspension a eu un impact sur la disponibilité des produits Macopharma stérilisés à l’oxyde d’éthylène.
La non-conformité qui concerne spécifiquement certains produits Macopharma est la suivante : une validation du procédé de stérilisation exige entre autres 3 cycles de stérilisation conformes consécutifs ; l’ ANSM a relevé la présence de 3 cycles de stérilisation conformes mais non consécutifs.
Les références des produits concernés sont :
- Dans la gamme biothérapie : XUV8501Q, CDR1000AU, CDR1005AU, CDR2005AU, CDR7000AU, CDR8000AU, XSR1010ZU, XSR2010ZU, XSR3010ZU
- Dans la gamme perfusion : BAA3100AD EPF0021A, EPF0023A, SX000003, BAA4100AD,
L’ ANSM a estimé que le retrait des produits concernés n’était pas nécessaire au vu des éléments apportés. Il n’y a pas de remise en cause de la sécurité des produits.
L’ANSM nous autorise à poursuivre les traitements et les libérations sous réserve d’effectuer des contrôles libératoires supplémentaires jusqu’à remise en conformité. Macopharma s’est engagé à mettre en place ces contrôles supplémentaires et à revalider sous 90 jours son cycle de stérilisation.
Restant à votre disposition pour toute information complémentaire, nous vous prions d’agréer, cher Confrère, chère Consœur, l’assurance de nos sentiments les meilleurs.
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.”
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.
See www.bloodsafety.macopharma.com for more information.
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.
See www.SynteractHCR.com for more information.
Please visit Macopharma Biotherapy at the 20th ISCT meeting to discover the first Macopharma GMP Platelet Lysate and a new creative cell culture media concept
Join us at our booths #38 & #39.
The 40th edition of the EBMT Congress (European Society for Blood & Marrow Transplantation) has been held on 30th March – April 2nd at the MICO Center in Milano
The 2014 show has been a resounding success with a record-breaking amount of delegates, visitors, speakers, sponsors.
MACO had the pleasure to receive distributors, customers and potential prospects on its booth #210 that did never empty during this 3 days-congress.
Each visitor got the opportunity to discover the various products of our PHOTOPHERESIS & CORD BLOOD ranges.
The main visitors came of course from Europe but also from Russia as well as South American & African countries like Tunisia and Chili.
We look forward to seeing you next year for this congress in Istanbul, from 22 – 25 March 2015.