Regulatory approval and a first‐in‐human phase I clinical trial of a monoclonal antibody produced in transgenic tobacco plants

Although plant biotechnology has been widely investigated for the production of clinical‐grade monoclonal antibodies, no antibody products derived from transgenic plants have yet been approved by pharmaceutical regulators for clinical testing. In the Pharma‐Planta project, the HIV‐neutralizing human...

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Vydané v:	Plant biotechnology journal Ročník 13; číslo 8; s. 1106 - 1120
Hlavní autori:	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, Mertens, Hubert, Paul, Mathew J, Rademacher, Thomas, Sack, Markus, Hundleby, Penelope A. C, Stiegler, Gabriela, Stoger, Eva, Twyman, Richard M, Vcelar, Brigitta, Fischer, Rainer
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	England Blackwell Pub 01.10.2015 John Wiley & Sons, Inc
Predmet:	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
ISSN:	1467-7644, 1467-7652
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