Rachel A Rodenbach, Thorunn Thordardottir, Markus Brauer, Aric C Hall, Earlise Ward, Cardinale B Smith, Toby C Campbell
Balancing risks and rewards: How hematologists discuss uncertainty in allogeneic hematopoietic cell transplantation outcomes
Patient education and counseling
lentiviral vectors lvvs used starting material generate chimeric antigen receptor car cells therefore lvvs need carefully analyzed ensure safety quality potency final product evaluated orthogonal complementary analytical techniques suitability characterize particulate matter impurities lvvs pharmaceutical lvv materials development stage derived suspension adherent manufacturing processes microfluidic resistive pulse sensing mrps additional manual data fitting enabled assessment mode diameters particles expected lvv size range material adherent production lvv material suspension process however contained substantial amounts particulate impurities blocked mrps cartridges sedimentationvelocity analytical ultracentrifugation svauc resolved lvv peak material adherent production well whereas polydisperse samples suspension production presence particulate impurities masked potential signal assignable lvvs interferometric light microscopy ilm nanoparticle tracking analysis nta lower size detection limits close 70 nm resulted apparent peak particle size distributions expected size lvvs emphasizing need interpret data care interpretation data dynamic light scattering dls limited insufficient size resolution sample polydispersity conclusion analysis lvv products manufactured pharmaceutical scale current stateoftheart physical nanoparticle characterization techniques challenging due presence particulate impurities heterogeneous size among evaluated techniques mrps svauc promising yielding acceptable results least material adherent production