The clearance of viruses and transmissible spongiform encephalopathy agents from biologicals.
The viral and transmissible spongiform encephalopathy (TSE) safety of therapeutics of biological origin (biologicals) is greatly influenced by the nature and degree of variability of the source material and by the mode of purification. Plasma-derived and recombinant DNA products currently have good viral safety records, but challenges remain. In general, large enveloped viruses are easier to remove from biologicals than small 'naked' viruses. Monoclonal antibodies and recombinant DNA biopharmaceuticals are derived from relatively homogeneous source materials and purified by multistep schemes that are robust and amenable to scientific analysis and engineering improvement. Viral clearance is more challenging for blood and cell products, as they are complex and labile. Source selection (e.g. country of origin, deferral for CJD risk factors) currently occupies the front line for ensuring that biologicals are free of TSE agents, but robust methods for their clearance from products are under development.
Farshid
Mahmood
M
Office of Blood Research and Review, Center for Biologics Evaluation, Center for Drug Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, USA.
Taffs
Rolf E
RE
Scott
Dorothy
D
Asher
David M
DM
Brorson
Kurt
K
D000911:Antibodies, Monoclonal / Q000302:isolation & purification; D001688:Biological Products / Q000302:isolation & purification*; D001709:Biotechnology / Q000379:methods* / Q000592:standards; D004340:Drug Contamination / Q000517:prevention & control; D006801:Humans; D004364:Pharmaceutical Preparations / Q000302:isolation & purification; D017096:Prion Diseases / Q000097:blood / Q000517:prevention & control / Q000635:transmission; D011328:Prions / Q000302:isolation & purification*; D011786:Quality Control; D011994:Recombinant Proteins / Q000302:isolation & purification; D014777:Virus Diseases / Q000097:blood / Q000517:prevention & control / Q000635:transmission; D038301:Virus Inactivation; D014780:Viruses / Q000302:isolation & purification*
D000911:Antibodies, Monoclonal; D001688:Biological Products; D004364:Pharmaceutical Preparations; D011328:Prions; D011994:Recombinant Proteins