Ensuring the pathogen safety of intravenous immunoglobulin and other human plasma-derived therapeutic proteins.
Countless patients and clinicians rely on therapeutic proteins, such as intravenous immunoglobulins (IVIGs), isolated from human blood plasma. Since plasma is predisposed to contamination by a variety of blood-borne pathogens, ascertaining and ensuring the pathogen safety of plasma-derived therapeutics is a priority among manufacturers. Even though the pathogen safety records for IVIG and other plasma proteins are excellent, the industry remains active in research programs aimed at improving the margin of safety. Industry initiatives designed to increase the safety of plasma-derived products range from donor screening and testing to implementing methods into the manufacturing processes that can inactivate or remove pathogens from product streams. In general, the industry's comprehensive strategy is designed to provide patients and caregivers with the safest plasma products possible.
Miller
J L
JL
Department of Pathogen Safety Research/Biological Products, Bayer Corp, Research Triangle Park, NC 27709, USA.
Petteway
S R
SR
Lee
D C
DC
D001419:Bacteria; D001798:Blood Proteins / Q000302:isolation & purification* / Q000627:therapeutic use; D004340:Drug Contamination; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000302:isolation & purification* / Q000627:therapeutic use; D012449:Safety; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards; D014780:Viruses
D001798:Blood Proteins; D016756:Immunoglobulins, Intravenous