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LFB, Laboratoire francais du fractionnement et des biotechnologies (French plasma fractionator) logo

LFB, Laboratoire francais du fractionnement et des biotechnologies (French plasma fractionator)

LFB is the French plasma fractionator: the company that turns plasma collected in France into medicines such as clotting factors, immunoglobulins and albumin. It describes itself as created in 1994 and is today a societe anonyme majority owned by the State and currently wholly owned by it. Before 2006 it was a groupement d'interet public; an ordonnance of 28 July 2005 converted it into a company whose capital was held entirely by the State at creation, with a dedicated subsidiary holding the exclusive right to make plasma-derived medicines from blood collected by the Etablissement francais du sang. That makes LFB the point where French blood donation policy and prion risk policy meet, because it is the only industrial user of French plasma for fractionation and the body whose manufacturing steps are credited with removing prion infectivity. Its prion story runs along two tracks. The first is manufacturing. LFB says it was the first pharmaceutical company to use nanofiltration, in 1995, and that the validation of its prion removal steps was presented to the ANSM expert group in 2004. In October 2004 the Afssaps, the ANSM predecessor, ran a precautionary recall of LFB plasma-derived medicine lots and used the occasion to state that fractionation reduces prion risk and that a nanofiltration step added in 2001 gives an extra margin for factor VIII, factor IX and immunoglobulins. The second track is published method work: LFB authors have developed and published the assays used to measure prion removal, including a cell culture infectivity assay applied to a 15 nanometre nanofiltration step in albumin manufacture and, more recently, a characterisation of a 263K derived microsomal fraction as a prion source for nanofiltration validation. The live regulatory question is leukoreduction. France has required leukoreduction of plasma for fractionation since 1998 as a variant CJD precaution, with no European equivalent. In an opinion dated 26 June 2025 the HCSP, working with the ANSM, the EFS, LFB and prion specialists, recommended replacing the French standard with the European fresh frozen plasma standard for the 14 plasma-derived medicines LFB makes, judging worst case residual prion infectivity negligible at below 0.01 infectious doses per administration, while keeping leukoreduction for labile blood products and asking LFB to evaluate its alternative prion inactivation claims with methods consistent with current prion knowledge. Information only, not medical advice.

Key facts

  • LFB is a societe anonyme described on its own board page as a majority State-owned limited company currently wholly owned by the French State, with directors representing the State including one from the State investment agency.
  • It was previously a groupement d'interet public. An ordonnance dated 28 July 2005 converted it into a company, with conversion due on 1 January 2006 and the share capital held in its entirety by the State at creation; a dedicated subsidiary, meant to stay public whatever happened to the biotechnology arm, holds the exclusive right to make plasma-derived medicines from blood collected by the EFS under article L.5124-14 of the public health code, a supply monopoly the ministry said was kept for safety reasons.
  • LFB dates its own creation to 1994 and claims two firsts in biological safety: nanofiltration in the manufacture of plasma-derived medicinal products in 1995, and PCR detection of parvovirus B19 in plasma for fractionation in 1996.
  • Its biosafety page says the validation of its prion removal steps was presented to the ANSM expert group in 2004, and describes manufacturing as a second line of defence built from validated viral inactivation steps (dry heat, pasteurisation, pH 4 with pepsin, solvent detergent), nanofiltration as the specific removal step, and precipitation, chromatography, alumina gel adsorption and depth filtration as steps that also contribute. It gives no log reduction figure for prions.
  • In the notice accompanying the October 2004 precautionary recall of LFB plasma-derived medicine lots, the Afssaps stated that plasma fractionation includes several steps that improve safety against the prion risk and that a nanofiltration step introduced in 2001 adds a further margin for factor VIII, factor IX and immunoglobulins. It did not require nominative identification of recipients at that stage and said an expert group it convened would assess individual risk and whether recipients should later be informed.
  • The HCSP opinion of 26 June 2025, published online 17 July 2025, recommends replacing the French 1998 leukoreduction standard for plasma for fractionation (below 1.0 x 10^6 residual leukocytes per litre for at least 90 percent of production) with the European fresh frozen plasma standard (below 0.1 x 10^9 per litre for at least 90 percent), for the 14 plasma-derived medicines made by LFB, on the basis that worst case residual prion infectivity for those products is negligible, below 0.01 infectious doses (ID50) per administration. It recommends keeping leukoreduction for labile blood products, where it is the only measure that reduces residual prion risk.
  • The working group behind that opinion included the ANSM, the EFS and LFB alongside prion disease specialists, and the HCSP reviewed critically the alternative methods LFB claims can inactivate prions, recommending that LFB evaluate them with approaches consistent with current prion knowledge.
  • LFB authors publish the measurement methods behind prion removal claims. A 2010 Journal of Virological Methods paper, first author at LFB, describes a tissue culture infectivity assay in the transgenic MovS6 line that takes about eight weeks, uses far fewer animals than bioassay, has one TCID50 corresponding to four ID50 and is about 80 times more sensitive than Western blot, and applies it to the prion removal given by a 15 nanometre nanofiltration step in human albumin manufacture used as a model.
  • A 2007 Vox Sanguinis paper, first author at LFB, reports adding a 35 to 15 nanometre nanofiltration step to an existing solvent detergent factor VIII process to give two complementary removal or inactivation steps, with biological properties preserved and no virus detected in the filtrate; the abstract says TSE reduction factors were assessed but does not print them.
  • A Europe PMC search on LFB affiliations with prion terms returns a small, process-focused body of work: a 2024 Transfusion paper on characterising a 263K derived microsomal fraction as a prion source for nanofiltration validation studies, a 2014 Transfusion paper on decontamination of prions in a plasma product manufacturing environment, a 2007 Transfusion Clinique et Biologique paper on French measures against variant CJD transmission in plasma-derived products, and four patent records on a stable cell clone expressing a prion filed in 2010 and 2011 with an LFB first inventor.
  • LFB also appears on basic prion science papers. It is among the affiliations on a 2017 PLoS One study validating a real-time quaking-induced conversion assay that detected atypical bovine spongiform encephalopathy with 100 percent sensitivity and specificity in a French surveillance series and separated sporadic from variant CJD in human samples, alongside the ICM in Paris, ANSES Lyon, the CEA at Fontenay-aux-Roses and the Pitie-Salpetriere national CJD reference centre.
  • LFB was one of the founders of the Alliance BioSecure research foundation, with Baxter and the filtration, decontamination and testing firms Macopharma, Steris and Albhades Provence, and in 2008 the foundation board was chaired by an LFB director; the foundation's scope included checking elimination steps for plasma derivatives and labile blood products.
  • The European frame moved in the same direction as the French one. Revision 3 of the EMA CHMP reflection paper on CJD and plasma-derived and urine-derived medicinal products, adopted 30 May 2024, dropped the deferral of donors with a cumulative stay of a year or more in the United Kingdom between 1980 and 1996 for plasma for fractionation, citing the decline of variant CJD and risk reducing factors specific to plasma-derived medicines including prion reduction during manufacture. This was read only as search excerpts.

Timeline

  1. 1994LFB created, according to its own biosafety page.
  2. 1995LFB says it became the first pharmaceutical company to use nanofiltration in the manufacture of plasma-derived medicinal products.
  3. 2001A nanofiltration step is introduced for factor VIII, factor IX and immunoglobulins, later cited by the agency as an extra prion safety margin.
  4. 2004Validation of LFB prion removal steps is presented to the ANSM expert group.
  5. 2004Afssaps recall of LFB plasma-derived medicine lots is issued; the complementary notice follows on 22 October 2004.
  6. 2005An ordonnance converts the LFB from a groupement d'interet public into a societe anonyme, with conversion due 1 January 2006 and capital held entirely by the State.
  7. 2006Alliance BioSecure, co-founded by LFB, is recognised as of public utility.
  8. 2007Vox Sanguinis paper on a solvent detergent treated and 15 nanometre filtered factor VIII.
  9. 2010Journal of Virological Methods paper on a cell culture infectivity assay for prion titration applied to nanofiltration removal.
  10. 2017PLoS One RT-QuIC paper on atypical and classical BSE with an LFB affiliation.
  11. 2024EMA CHMP reflection paper revision 3 adopted, dropping the United Kingdom residence deferral for plasma for fractionation.
  12. 2025HCSP opinion recommends dropping the French leukoreduction step for plasma used to make the 14 LFB plasma-derived medicines.
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