June S. Sass
Research Subjects
June S. Sass has a total of 8 co-authors. Here are the top co-authors by number of shared publications:
- Anthony J. Clark
Helaina Inc., New York, NY, USA
1 shared publication - Bryce Ferraro
Helaina Inc., 345 Park Ave
1 shared publication - Carrie-Anne Malinczak
Helaina Inc
1 shared publication - Lance K. Blevins
Michigan State University: 1129 Farm Lane
1 shared publication - Norbert E. Kaminski
Department of Pharmacology and Toxicology, Michigan State University, East Lansing, Michigan; Institute for Integrative Toxicology, Michigan State University, East Lansing, Michigan; Center for Research on Ingredient Safety, Michigan State University, East Lansing, Michigan
1 shared publication - Robert Crawford
Michigan State University: 1129 Farm Lane
1 shared publication
Latest Publications
- Open Access
Dose range-finding toxicity study in rats with recombinant human lactoferrin produced in Komagataella phaffii
The oral toxicity of recombinant human lactoferrin (Helaina rhLF, Effera™) produced in Komagataella phaffii was investigated in adult Sprague-Dawley rats by once daily oral gavage for 14 consecutive days. The study used groups of 3-6 rats/sex/dose. The vehicle control group received sodium citrate buffer and the test groups received daily doses of 200, 1000 and 2000 mg of rhLF per kg body weight. Bovine LF at 2000 mg/kg body weight per day was used as a comparative control. Clinical observations, body weight, hematology, clinical chemistry, iron parameters, immunophenotyping, and gross examination at necropsy were used as criteria for detecting the effects of treatment in all groups and to inform dose levels for future toxicology studies. Quantitative LF levels were also analyzed as an indication of bioavailability. Overall, administration of Helaina rhLF by once daily oral gavage for 14 days was well tolerated in rats at levels up to 2000 mg/kg/day, or 400x Helaina’s intended commercial use, and indicating that a high dose of 2000 mg/kg/day is appropriate for future definitive toxicology studies.
Open AccessDose range-finding toxicity study in rats with recombinant human lactoferrin produced in Komagataella phaffii
The oral toxicity of recombinant human lactoferrin (Helaina rhLF, Effera™) produced in Komagataella phaffii was investigated in adult Sprague-Dawley rats by once daily oral gavage for 14 consecutive days. The study used groups of 3-6 rats/sex/dose. The vehicle control group received sodium citrate buffer and the test groups received daily doses of 200, 1000 and 2000 mg of rhLF per kg body weight. Bovine LF at 2000 mg/kg body weight per day was used as a comparative control. Clinical observations, body weight, hematology, clinical chemistry, iron parameters, immunophenotyping, and gross examination at necropsy were used as criteria for detecting the effects of treatment in all groups and to inform dose levels for future toxicology studies. Quantitative LF levels were also analyzed as an indication of bioavailability. Overall, administration of Helaina rhLF by once daily oral gavage for 14 days was well tolerated in rats at levels up to 2000 mg/kg/day, or 400x Helaina’s intended commercial use, and indicating that a high dose of 2000 mg/kg/day is appropriate for future definitive toxicology studies.