French laboratory of Fractionation and Biotechnologies

The French Laboratory of Fractionation and Biotechnologies is a laboratory French of state, whose production is primarily turned towards the fractionation of plasmatic proteins resulting from the blood plasma. It is the only French laboratory, has to be able to carry out this fractionation, on the plasma coming from the blood donations carried out in the French Établissement of blood. The LFB remains a world major actor of the fractionation of plasmatic protein. It is the the most advanced laboratory in this field. It extracts the broadest range from it from drugs not marketed to the public. It is present on almost all the fields of the blood diseases, and, on certain rare diseases. For certain factors of coagulation, it is the only ready one to carry out the drug. It completes also make up work, with plasma resulting from other countries and is used exclusively for the manufacture of the drugs intended for the countries silent partners (Morocco, Germany, England, Switzerland, Luxembourg….). It exports these products and has technical and commercial partnerships throughout the world.

The LFB is also a major world actor of research on the Biotechnologies.

Creation

Until 1993, the plasmatic products and derivatives were produced directly by the centers of blood transfusion, the products being regarded as blood derivatives. The law of January 4th, 1993, separates the activities following the classification from plasmatic proteins and their derivatives in subjected drugs has a control of French Agency of public health of the health products and having to duly obtain an authorization to be marketed.

The January 20th 1994 is created convention constitutive of GIP LFB and by the decree of the May 19th 1994, it is approved. GIP is definitively created on June 1st 1994. The head office is established to the 37 of the street Violet, Paris XVe.

Constitution

GIP LFB consists of eight major actors:

  1. the State represented by the minister of state, Minister for the social affairs, health and the city,

  2. the French Agency of blood,
  3. the association of Aquitaine for the development of the blood transfusion and hematologic research,
  4. association for the rise of the blood transfusion in the area of North,
  5. the Lyons association of the blood transfusion,
  6. the regional association of blood transfusion of Strasbourg,
  7. the regional center of blood transfusion of Montpellier,
  8. the national Foundation of blood transfusion.

Mission

The laboratory with for mission of:

  • To prepare the drugs blood derivative subjected to the provisions of the book V of the public health code. He carries on this activity of preparation starting from blood or his components collected by the establishments of blood transfusion. He also carries on the research activities and of production concerning the drugs likely to replace the derivative products of blood.

LFB, Public limit company

To make following the law of modernization of the right of the June 8th 2004, GIP LFB is transformed into Public limit company private law and subsidiary companies are created to distinguish the " activity; Fractionnement" and the " activity; R & D ". In the official journal of the July 29th 2005 is published ordinance 2005-866 of July 28th, 2005 transforming the Groupement of public interest called “French Laboratory of fractionation and biotechnologies” into public limit company.

- Art L5124-14 of the Public health code Modified by Ordinance n°2005-866 of July 28th, 2005 Article 3 (JORF July 29th, 2005).

  • “a moral person having for object the activity of collection of blood or its components cannot hold direct or indirect participation in the public limit company “Laboratory French of fractionation and biotechnologies” and in the companies controlled by this one within the meaning of the article L. 233-3 of the commercial law.

  • “the public limit company “Laboratory French of fractionation and biotechnologies” and the companies controlled by this one within the meaning of the article L. 233-3 of the commercial law cannot hold direct or indirect participation in a moral person having for object the activity of collection of blood or its components. ”

For this reason, the establishments of blood previously incorporated in the GIE are drawn aside and the state shareholder, become it at 100%. LFB SA is definitively created the July 7th 2006. In the long term, the capital will have to mainly remain held by the French state where these public corporations, but it could be open to the other investors.

Two subsidiary companies will be created:

  • LFB Biomédicaments which has in load the production activity of drug and fractionation of the plasma,
  • LFB Biotechnologies which has in load the research activity in Biotechnologies and in the creation of substitute to the blood derivatives.

Exclusiveness in Fractionation

The article L. 5124-14 of the public health code, grants LFB Biomédicaments, the subsidiary company of the LFB which has in load the fractionation of plasma, to be able to manufacture drugs blood derivative starting from blood or from its components collected by the French Establishment of blood.

Device of the donor to the patient says “general system”

The general system is a device of security. That makes it possible to follow the quality of plasma in all times. It is composed of 11 principal points, more, 5 complementary points:
  • medical Selection of the donor:
According to the criteria of French ethics: Voluntary help, anonymity, voluntariate, Information before the gift, Questionnaire of Health, medical Maintenance, examination, information after the gift, follow-up of the donor.

  • Taking away

Respect of the transfusional good practices (material sterile etc…), Correct Identification of the gifts, destruction of the damaged products.

  • Control of the gifts

Tests in laboratories for the checking of nonthe presence of diseases.

  • Preparation, Déleucocytation, Congelation

After preparation and Déleucocytation, plasma is frozen with -40°c approximately, to ensure its good conservation. It is preserved one year, beyond that, it must be destroyed.

  • Arrived at the Laboratory

Transported by a person receiving benefits of the LFB, plasma is conveyed EFS by freezer wagon which also transports it to -40°c approximately. The collections are made on the technical plates of blood through all the France. The transport conditions and the follow-up of the temperature of transport are recorded and controlled as well as the documents of transport. Each reception is identified and recorded by an identification number and the date of reception. Each number of gift is recorded for the traceability. The detachable pipe of the pocket containing of the Blood plasma is used to control the absence of various diseases.

  • Quality control

The batches are recorded and quarantined. The laboratory carries out virological controls on the pockets to confirm the absence of diseases.

  • Forty before fractionation

All the pockets being able to be used for fractionation after all the tests in laboratories (checks of the diseases possible and present in plasma) are quarantined 50 days before their use. The total duration of forty is 90 days.

  • Control before fractionation

The batches are released from their forty, and are treated in production. The homgene mixture of a batch of plasma for fractionation still undergoes a battery of test. If those are negative, the batch is good for fractionation if not it is the destruction by incineration.

  • Proceeded specific of security

The purpose of purification, viral inactivation and nano filtration are to remove plasma of any virus (or the inactiver) before its setting in end product.

  • Control of the drug

Each batch of drug is controlled before its marketing by processes specific and in conformity with the schedule of conditions of the marketing authorization.

  • Regulation, Dispensation

The drug finished and available, it can be prescribed and used for the patients.

The 5 complementary points are:

  • Traceability, hémovigilance, pharmacovigilance, program quality assurance and to that quality. The laboratory is actor of all these processes and respect them in accordance with the provisions in force and with the recommendations of AFSSAPS.

Products

The LFB markets a range of 20 drugs resulting from plasmatic proteins. Here 17 drugs of the range among most current and their applications:

  • blood Factors of coagulation

  • WILSTART®

Factor of von Willebrand, Human Factor VIII
  • WILFACTIN®
Factor of von Willebrand
  • KASKADIL®
Human Factor X, Factor II, Factor VII, Factor IX
  • HEMOLEVEN®
Human Factor XI
  • Factor VII LFB®
human Factor VII of plasmatic origin
  • FACTANE®
Human Factor VIII of plasmatic origin (specific activity higher than 100 UI /mg of proteins)
  • CLOTTAGEN®
human Fibrinogen
  • BETAFACT®
human Factor IX

  • Inhibiting of coagulation
  • ACLOTINE®
Antithrombine III human of plasmatic origin

  • human Albumin
  • VIALEBEX®
Substitute of Plasma, albumin

  • human Immunoglobulins
  • TEGELINE®
general-purpose human Immunoglobulins
  • IVHEBEX®
Human immunoglobulins anti hepatitis B
    injectable
  • IHS 500Ul
Human immunoglobulins anti hepatitis B, immunoglobulins has
  • GAMMATETANOS®
Human immunoglobulins G anti tetanic of plasmatic origin

  • Application to Guillain-Barred
  • TEGELINE®
Syndrome of Guillain-Barred

  • Prevention of the hello-immunization fœto-nursery school
  • RHOPHYLAC®
Immunoglobulins anti-D

  • Human Protein C
  • PROTEXEL®
Human Protein C

  • Deficit in Alpha 1-antitrypsin
  • ALFALASTIN®
Alpha 1-antitrypsin human

In Figures

The laboratory treats a little more than 500.000 patients per annum. 20 drugs 36 presentations 93 Marketing authorizations in 18 countries

Establishment

The LFB is established at 5 places:
  • Ulis Head office, Research center, Production center, store plasma and general store,
  • Lille Production center and store plasma. The site is established partly in buildings of the Northern EFS of France which was transferred to him into clean during creation of LFB SA,
  • Carvin Central Magasins and Pharmaceutical,
  • Loos Research center of biotechnologies on the Eurasanté park which has an incubating bio,
  • Paris Bureaux.

G5

The laboratory is member of G5. G5 gathers 5 actors of the drug and the research advanced on the French territory. The goal of the grouping is to maintain their decision-making centres on the national territory. All the adherent companies make research “their priority”.

The grouping founds its values around 9 axes (5 in the charter founder and 4 in the objectives & missions):

- Charter Founder:

  • To make recognize the adherent pharmaceutical companies like natural partners of the public authorities in terms of medical independence and promotion of the objectives of public health defined by the State
  • To make recognize the companies founders like essential actors of research in France, contributing already strongly to the development of the public laboratories
  • To make recognize the capacity of innovation of these companies and obtain that their development is recognized as strategic priority
  • Obtenir that are evaluated and taken into account the consequences of the policy of the drug in industrial terms and attractivity of the territory
  • Promouvoir a policy of the right care to the fair price while taking care to remunerate in a so much balanced way them innovations that drugs with tested therapeutic value.

- Objectives & Missions:

  • medical independence,
  • the excellence of research,
  • the French innovation,
  • the international radiation.

Bonds

  • law 93.5 of January 4th, 1993 relating to safety as regards blood transfusion and drug
  • Ratification of the ordinance 2005-866
  • bond on lfb.fr relating to ordinance 2005-866 of July 28th, 2005 transforming the grouping of public interest called “French Laboratory of fractionation and biotechnologies” into public limit company.
  • G5, Groupings of the laboratories

To read

  • Opinion column of the humanité.fr of Jean-Pierre Basset hound, militant of the gift of the blood, devoted to the failure of the marchandisation of the health products
  • Questions with the Government (feared transformation into SA)
  • Feared Northern EFS of France following the change of status and with the abandonment of credits
  • sfar.org Fractions coagulating of plasma
  • sfar.org News organization of the blood transfusion in France

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