Nanofiltration of plasma‐derived biopharmaceutical products
Tóm tắt
Nanofiltration of plasma products has been implemented at a production scale in the early 1990s to improve margin of viral safety, as a complement to the viral reduction treatments, such as solvent–detergent and heat treatments, already applied for the inactivation of human immunodeficiency virus, hepatitis B and hepatitis C virus. The main reason for the introduction of nanofiltration was the need to improve product safety against non‐enveloped viruses and to provide a possible safeguard against new infectious agents potentially entering the human plasma pool.
Nanofiltration has gained quick acceptance as it is a relatively simple manufacturing step that consists in filtering protein solution through membranes of a very small pore size (typically 15–40 nm) under conditions that retain viruses by a mechanism largely based on size exclusion. Recent large‐scale experience throughout the world has now established that nanofiltration is a robust and reliable viral reduction technique that can be applied to essentially all plasma products. Many of the licensed plasma products are currently nanofiltered.
The technology has major advantages as it is flexible and it may combine efficient and largely predictable removal of more than 4 to 6 logs of a wide range of viruses, with an absence of denaturing effect on plasma proteins. Compared with other viral reduction means, nanofiltration may be the only method to date permitting efficient removal of enveloped and non‐enveloped viruses under conditions where 90–95% of protein activity is recovered. New data indicate that nanofiltration may also remove prions, opening new perspectives in the development and interest of this technique. Nanofiltration is increasingly becoming a routine step in the manufacture of biopharmaceutical products.
Từ khóa
Tài liệu tham khảo
Hughes BA, 1996, Evaluation of anti‐viral filters, Dev Biol Stand, 88, 91
Viresolve, 2002, Virus and Application Filtration Guide
Element Data Sheet F1 1996 OMEGA VR TM virus reduction membrane
Manabe S., 1996, Removal of virus through novel membrane filtration method, Dev Biol Stand, 88, 81
Ide S. Development of new Planova® membrane – the Planova® 2ON filter. Planova® Workshop Japan A Forum for Exchanging Information on the Latest Developments in Virus Removal Filtration. Tokyo:Asahi Kasei Corporation November 1 2000.
Yamaguchi K, 1991, Microparticle removability of the regenerated cellulose hollow fiber (BMM): an electron microscopic evaluation, J Electron Microsc, 40, 337
Viresolve NFP filters.Data Sheet. Millipore9/1/2001.
Viresolve NFR filters.Data Sheet. Millipore12/99.
Graf EG, 1999, Virus removal by filtration, Dev Biol Stand, 99, 89
Brandwein H, 2000, Membrane filtration for virus removal, Dev Biol Stand, 102:157
Validation Guide VG‐DV20 Pall ULTIPOR VF Grade DV20 AB style virus removal filter cartridges.Pall BioPharmaceuticals 2000.
Aranha‐CreadoH OshimaK JafariS HowardG BrandweinH.Virus retention by Ultipor VF grade DV50 membrane filters. Pall STR1543.
Aranha‐Creado H, 1997, Virus retention by a hydrophilic triple‐layer PVDF microporous membrane filter, PDA J Pharm Sc Technol, 51, 119
Burnouf T., 1993, Chromatographic removal of viruses from plasma derivatives, Dev Biol Stand, 81, 199
Guidelines on Viral Inactivation and Removal Procedures Intended to Assure the Viral Safety of Human Blood Plasma Products. In:HorowitzB MinorP MorgenthalerJJ BurnoufT McIntoshR PadillaA Thorpe R. (drafting group) Geneva: WHO. BS/01/1941 2002(in press).
Rosendaal FR, 1993, A sudden increase in factor VIII inhibitor development in multitransfused hemophilia patients in The Netherlands, Blood, 81, 10.1182/blood.V81.8.2180.2180
Mannucci PM, 1995, Preliminary evaluation of a nanofiltered factor IX concentrate, Thromb Haemost, 73, 737, 10.1055/s-0038-1653859
Yunoki M, 2000, A Forum for Exchanging Information on the Latest Developments in Virus Removal Filtration
Feldman P, 1998, To Meet and Exchange Information on the Latest Developments in Virus Removal Technology, 47
Romisch J, 1996, Nanofiltration in production of Beriplex P/N: increasing the capacity of virus elimination while maintaining product quality, Beitr Infusionsther Transfusionsmed, 33, 220
Nowak T, 1998, To Meet and Exchange Information on the Latest Developments in Virus Removal Technology, 16
Over J, 1998, To Meet and Exchange Information on the Latest Developments in Virus Removal Technology, 5
Maeno H, 2000, A Forum for Exchanging Information on the Latest Developments in Virus Removal Filtration, 21
Chtourou S, A Forum for Exchanging Information on the Latest Developments in Virus Removal Filtration, 91
Rothschild F, 1999, Factor VIII SD‐35‐15: Preliminary Results of a Cross‐Over Pharmacokinetic Study of SD and 35–15 nm Filtered Factor VIII Concentrate Compared to Reference Product (SD Factor VIII Concentrate)
Borel‐Derlon A, 2000, Plasma‐Derived Medical Products and Haemostasis: Current Issues and Perspectives
Yap PL, 1992, Clinical Applications of Intravenous Immunoglobulin Therapy, 43
Dichtelmuller H, 1998, To Meet and Exchange Information on the Latest Developments in Virus Removal Technology, 27
Suomela H, 1998, To Meet and Exchange Information on the Latest Developments in Virus Removal Technology, 38
Hong F, 1998, Safety profile of WinRho anti‐D, Semin Hematol, 35, 9
Price H, 1999, A Forum for Exchanging Information on the Latest Developments in Virus Removal Technology, 21
Maeno H, 2000, A Forum for Exchanging Information on the Latest Developments in Virus Removal Filtration, 22
Poulle M, 1994, Large‐scale preparation of highly purified human C1‐inhibitor for therapeutic use, Blood Coag Fibrinolysis, 5, 543
BunchC KavanaghC HeldebrantC BhattacharyaP CraigWC.Alpha‐1 Proteinase Inhibitor (A1PI) Virus Reduction Studies.XVII Congress of the International Society on Thrombosis and Haemostasis Washington DC USA August 1421 1999 no. 912 (Abstracts).
Bunch C, 1999, A Forum for Exchanging Information on the Latest Developments in Virus Removal Technology, 35
Kuroda Y, 1983, Creutzfeldt‐Jakob disease in mice: persistent viremia and preferential replication of virus in low density lymphocytes, Infect Immun, 41, 154, 10.1128/iai.41.1.154-161.1983
Hunter N, 2002, Can prion diseases be transmitted between individuals via blood transfusion: evidence from sheep experiments, Dev Biol, 108, 93
MacGregor I, 1999, Normal prion protein is found in human plasma, but is removed by the SNBTS plasma fractionation process, Thromb Haemost, 82, 86
Blum M, 1998, A bovine spongiform encephalopathy validation study for aprotinin and bovine serum albumin, Biopharm, 11, 28
Carter J, 2002, An overview of viral filtration in biopharmaceutical manufacturing, Eur J Parent Sci, 7, 72