Roma Vishwanath-Deutsch
Research Subjects
Roma Vishwanath-Deutsch has a total of 13 co-authors. Here are the top co-authors by number of shared publications:
- Anthony J. Clark
Helaina Inc., New York, NY, USA
2 shared publications - Carrie-Anne Malinczak
Helaina Inc
2 shared publications - Ross Peterson
Helaina Inc., New York, NY, USA
2 shared publications - Bryce Ferraro
Helaina Inc., 345 Park Ave
1 shared publication - Claire Kruger
Spherix Consulting Group, Rockville, MD, USA
1 shared publication - David Charles Dallas
Department of Food Science & Technology, Oregon State University, Corvallis, OR 97331, USA; Nutrition Program, College of Health, Oregon State University, Corvallis, OR 97331, USA
1 shared publication
Latest Publications
- Open Access
- 10 May 2024
- Published by Elsevier in Food and Chemical Toxicology
- Vol. 189, 114727
A review of the safety evidence on recombinant human lactoferrin for use as a food ingredient
- 10 May 2024
- Published by Elsevier in Food and Chemical Toxicology
- Vol. 189, 114727
Open AccessA review of the safety evidence on recombinant human lactoferrin for use as a food ingredient
- 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.