Regulatory approval and a first‐in‐human phase I clinical trial of a monoclonal antibody produced in transgenic tobacco plants - Ma, Julian K‐C; Drossard, Jürgen; Lewis, David; Altmann, Friedrich; Boyle, Julia; Christou, Paul; Cole, Tom; Dale, Philip; van Dolleweerd, Craig J; Isitt, Valerie; Katinger, Dietmar; Lobedan, Martin; et al. (Plant biotechnology journal, 2015)
Keywords: Acquired immune deficiency syndrome; AIDS; Animals; Antibodies; Antibodies, Monoclonal - biosynthesis; Antibodies, Monoclonal - therapeutic use; Application programming interface; biopharmaceuticals; Biotechnology; Broadly Neutralizing Antibodies; Cell culture; Clinical trials; Disease transmission; Drug Approval; Ebola virus; ethics; Female; females; Germany; Glycomics; good manufacturing practice; good manufacturing practices; guanosine monophosphate; Guidelines; HIV; HIV Antibodies; Human immunodeficiency virus; human trial; Humans; Immune system; Infections; ingredients; loci; Manufacturing; Medical research; Molecular Sequence Data; Monoclonal antibodies; monoclonal antibody; Nicotiana - genetics; Nicotiana tabacum; Pharmaceuticals; phase I; Phenotype; plantibodies; Plants (organisms); Plants, Genetically Modified; Protein Stability; Proteins; Proteomics; Rabbits; Regulators; Regulatory approval; Seed banks; Seeds; Social Control, Formal; standard operating procedures; Tobacco; Transformation, Genetic; Transgenes; Transgenic; Transgenic plants; Trends; United Kingdom; United Kingdom; Germany; United States--US; transgenic plants; phase I; tobacco; human trial; monoclonal antibody; good manufacturing practice