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

doi:10.1111/pbi.12416

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

Plant biotechnology journal - 1 Oct 2015

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

Abstract excerpt

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 monoclonal antibody 2G12 was expressed in transgenic tobacco (Nicotiana tabacum). The scientific, technical and...

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PMID: 26147010
DOI: 10.1111/pbi.12416

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