title: Virus removal capacity at varying ionic strength during nanofiltration of AlphaNine® SD.
abstract: Nanofiltration is incorporated into the manufacturing processes of many protein biopharmaceuticals to enhance safety by providing the capacity to retain pathogens while allowing protein drugs to pass through the filter. Retention is mainly a function of size; however, the shape of the pathogen may also influence retention. The ability of the Viresolve(®) Pro nanofilter to remove different sized viruses during the manufacture of a Coagulation Factor IX (Alphanine(®) SD) was studied at varying ionic strength, a process condition with the potential to affect virus shape and, hence, virus retention. Eight viruses were tested in a scale-down of the nanofiltration process. Five of the viruses (EMCV, Reo, BVDV, HIV, PRV) were nanofiltered at normal sodium processing conditions and three (PPV, HAV and WNV) were nanofiltered at higher and lower sodium. Representative Reduction Factors for all viruses were ≥4.50 logs and removal was consistent over a wide range of ionic strength.
authors.affiliation: Research and Development Department, Grifols Biologicals Inc., 5555 Valley Boulevard, Los Angeles, CA 90032, USA. Electronic address: nuria.jorba@grifols.com.
authors.forename: Nuria
authors.initials: N
authors.lastname: Jorba
authors.affiliation: Research and Development Department, Grifols Biologicals Inc., 5555 Valley Boulevard, Los Angeles, CA 90032, USA. Electronic address: ken.shitanishi@grifols.com.
authors.forename: Kenneth T
authors.initials: KT
authors.lastname: Shitanishi
authors.affiliation: Research and Development Department, Grifols Biologicals Inc., 5555 Valley Boulevard, Los Angeles, CA 90032, USA. Electronic address: clint.winkler@grifols.com.
authors.forename: Clint J
authors.initials: CJ
authors.lastname: Winkler
authors.affiliation: Research and Development Department, Grifols Biologicals Inc., 5555 Valley Boulevard, Los Angeles, CA 90032, USA. Electronic address: steven.herring@grifols.com.
authors.forename: Steven W
authors.initials: SW
authors.lastname: Herring
mesh_terms: D001688:Biological Products / Q000302:isolation & purification; D004340:Drug Contamination / Q000517:prevention & control; D005164:Factor IX / Q000302:isolation & purification*; D006801:Humans; D008851:Micropore Filters; D036103:Nanotechnology; D009994:Osmolar Concentration; D010316:Particle Size; D014462:Ultrafiltration / Q000379:methods*; D014780:Viruses / Q000302:isolation & purification* / Q000648:ultrastructure
chemical_list: D001688:Biological Products; D005164:Factor IX
keywords: AlphaNine(®) SD; Factor IX; Ion strength; Nanofiltration; Viral safety; Virus removal