Four-Week GLP Immunotoxicity Assessment of Lactoferrin Alpha Produced by Komagataella phaffii in Sprague-Dawley Rats

Oral toxicity and toxicokinetic properties of human lactoferrin alpha produced in Komagataella phaffii (effera™) were investigated in adult Sprague-Dawley rats over a 28-day period under good laboratory practice conditions. Test groups received daily doses of 200, 600, and 2000 mg effera™/kg body weight, with a comparative control receiving 2000 mg bovine LF/kg/day. T-cell-dependent antibody response and splenic immunophenotyping were performed as immunotoxicity measures, alongside clinical observations, body weight, hematology, coagulation, clinical chemistry, urinalysis, gross necropsy, histopathology, toxicokinetics, and anti-LF antibody assays. No treatment-related toxicologically significant changes were observed. effera™ was well tolerated in rats at doses up to 2000 mg rhLF/kg/day, roughly 400 times the estimated daily intake at the 90th percentile proposed for human adult use.