Workshop report: A study roadmap to evaluate the safety of recombinant human lactoferrin expressed in Komagataella phaffii intended as an ingredient in conventional foods – Recommendations of a scientific expert panel

Author:

Malinczak Carrie-AnneORCID,Burns Naas Leigh AnnORCID,Clark Anthony,Conze Dietrich,DiNovi Michael,Kaminski Norbert,Kruger Claire,Lönnerdal BoORCID,Lukacs Nicholas W.,Merker RobertORCID,Peterson RossORCID

Publisher

Elsevier BV

Reference83 articles.

1. Sub-chronic (13-week) oral toxicity study in rats with recombinant human lactoferrin produced in the milk of transgenic cows;Appel;Food Chem. Toxicol.,2006

2. Managing the impact of immunogenicity in an era of immunotherapy: from bench to bedside;Bray-French;J. Pharmaceut. Sci.,2021

3. INFOGEST static in vitro simulation of gastrointestinal food digestion;Brodkorb;Nat. Protoc.,2019

4. Regulatory framework for substances intended for use in human food or animal food on the basis of the generally recognized as safe (GRAS) provision of the federal food, drug, and cosmetic act: guidance for industry,2017

5. 28-day repeated dose oral toxicity of recombinant human apo-lactoferrin or recombinant human lysozyme in rats;Cerven;Regul. Toxicol. Pharmacol.,2008

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