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

Plant Biotechnology Journal

Volumn 13, Issue 8, 2015, Pages 1106-1120

  Ma, Julian K C ^a   Drossard, Jürgen ^b,c   Lewis, David ^a   Altmann, Friedrich ^d   Boyle, Julia ^e   Christou, Paul ^f,g   Cole, Tom ^a   Dale, Philip ^h   van Dolleweerd, Craig J ^a   Isitt, Valerie ^a   Katinger, Dietmar ⁱ   Lobedan, Martin ^b,c   Mertens, Hubert ^b,c   Paul, Mathew J ^a   Rademacher, Thomas ^b,c   Sack, Markus ^b,c   Hundleby, Penelope A C ^h   Stiegler, Gabriela ⁱ   Stoger, Eva ^b,c   Twyman, Richard M ^j   Vcelar, Brigitta ⁱ   Fischer, Rainer ^b,c   more..

^a ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^b FRAUNHOFER INSTITUTE FOR MOLECULAR BIOLOGY AND APPLIED ECOLOGY IME   (Germany)

^c RWTH AACHEN UNIVERSITY   (Germany)

^d UNIVERSITY OF NATURAL RESOURCES AND LIFE SCIENCES   (Austria)

^e UNIVERSITY OF SURREY   (United Kingdom)

^f UNIVERSITY OF LLEIDA   (Spain)

^g INSTITUCIÓ CATALANA DE RECERCA I ESTUDIS AVANÇATS ICREA   (Spain)

^h NORWICH RESEARCH PARK   (United Kingdom)

ⁱ POLYMUN SCIENTIFIC IMMUNBIOLOGISCHE FORSCHUNG GMBH   (Austria)

^j TRM Ltd   (United Kingdom)

more..

Author keywords

Good manufacturing practice; Human trial; Monoclonal antibody; Phase I; Tobacco; Transgenic plants

Indexed keywords

2G12 MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY;

ANIMAL; BIOSYNTHESIS; CLINICAL TRIAL; CONTROLLED STUDY; DRUG APPROVAL; FEMALE; GENETIC TRANSFORMATION; GENETICS; GLYCOBIOLOGY; HUMAN; MOLECULAR GENETICS; PHASE 1 CLINICAL TRIAL; PHENOTYPE; PROTEIN STABILITY; PROTEOMICS; RABBIT; RANDOMIZED CONTROLLED TRIAL; SOCIAL CONTROL; TOBACCO; TRANSGENIC PLANT;

ANIMALS; ANTIBODIES, MONOCLONAL; DRUG APPROVAL; FEMALE; GLYCOMICS; HUMANS; MOLECULAR SEQUENCE DATA; PHENOTYPE; PLANTS, GENETICALLY MODIFIED; PROTEIN STABILITY; PROTEOMICS; RABBITS; SOCIAL CONTROL, FORMAL; TOBACCO; TRANSFORMATION, GENETIC;

EID: 84942199585     PISSN: 14677644     EISSN: 14677652     Source Type: Journal    
DOI: 10.1111/pbi.12416     Document Type: Article

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