The removal of viruses during the purification of equine antisera using filtration aids Hyflo Super-Cel and Fulmon Super A.
The manufacturing process in Australia for equine antisera against various venoms/toxins is based primarily on ammonium sulphate precipitation of pepsin-digested IgG, whereby Fc and F(ab')(2)fragments are separated. The capacity of the process to remove non-enveloped and enveloped model viruses was assessed using a scaled-down process. Each virus was added to mid-process samples from equine plasma before the material was applied to Hyflo Super-Celtrade mark filtration followed by Fulmonttrade mark Super A filtration. Samples were analysed pre- and post-filtration and the log clearance of the viruses calculated. The mean clearance factors for viral load of canine adenovirus type II (CAV(2)), poliovirus type 1 (PV1), infectious bovine rhinotracheitis virus (IBR) and canine distemper virus (CDV) were 5.3 logs, 4.2 logs, 5.7 logs and 4. 0 logs respectively. Clearance results as virus is adsorbed to the filtration aids which are removed from the process, thereby demonstrating improved viral safety of equine antisera produced by CSL.
Cameron-Smith
R
R
Quality Operations, CSL Limited, Parkville, Victoria, 3052, Australia.
Miloradovic
L
L
Cheyne
I
I
Healy
K
K
D006516:Adenoviruses, Canine / Q000302:isolation & purification; D000818:Animals; D001315:Australia; D002417:Cattle; D004217:Distemper Virus, Canine / Q000302:isolation & purification; D004285:Dogs; D004340:Drug Contamination / Q000517:prevention & control*; D007242:Herpesvirus 1, Bovine / Q000302:isolation & purification; D006736:Horses; D007106:Immune Sera; D018103:Morbillivirus / Q000302:isolation & purification; D014118:Toxins, Biological / Q000276:immunology; D014462:Ultrafiltration / Q000295:instrumentation* / Q000379:methods; D014688:Venoms / Q000276:immunology; D014780:Viruses / Q000302:isolation & purification*
D007106:Immune Sera; D014118:Toxins, Biological; D014688:Venoms