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

@article{Ma2015RegulatoryAA,
  title={Regulatory approval and a first-in-human phase I clinical trial of a monoclonal antibody produced in transgenic tobacco plants.},
  author={Julian K-C Ma and Juergen Drossard and David J Lewis and Friedrich Altmann and Julia Boyle and Paul Christou and Tom Cole and Philip J. Dale and Craig J. van Dolleweerd and Valerie Isitt and Dietmar Katinger and Martin Lobedan and Hubert Mertens and Mathew Paul and Thomas Rademacher and Markus Sack and Penelope A C Hundleby and Gabriela Stiegler and Eva Stoger and Richard M Twyman and Brigitta A. Vcelar and Rainer Fischer},
  journal={Plant biotechnology journal},
  year={2015},
  volume={13 8},
  pages={1106-20}
}
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 regulatory demands of good manufacturing practice (GMP) were addressed by… CONTINUE READING
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Structural basis for enhanced HIV-1 neutralization by a dimeric immunoglobulin G form of the glycan-recognizing antibody 2G12

  • Y. Wu, West, +4 authors P. J. Bjorkman
  • Cell Rep
  • 2013
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