New generations of recombinant and plasma-derived therapeutics, with improv
ed purity and viral safety, are now available; however, these biotherapeuti
cs may still carry risks of bloodborne or cell culture-derived virus transm
ission, Creutzfeldt-Jakob disease or non-Creutzfeldt-Jakob disease transmis
sion, and inhibitor development. Thus, ensuring their optimal safety profil
e remains of critical importance, especially with regard to pathogen transm
ission, thrombogenic risk, and immunogenicity.