Journal ArticleDOI
Production of human monoclonal antibody in eggs of chimeric chickens
Lei Zhu,Marie-Cecile van de Lavoir,Jenny Albanese,David O. Beenhouwer,Pina M. Cardarelli,Severino Cuison,David F Deng,Shrikant Deshpande,Jennifer H. Diamond,Lynae Green,Edward L. Halk,Babette S. Heyer,Robert M. Kay,Allyn Kerchner,Philip Albert Leighton,Christine Mather,Sherie L. Morrison,Zivko L. Nikolov,David Passmore,Alicia Pradas-Monne,Benjamin T. Preston,Vangipuram S. Rangan,Mingxia Shi,Mohan Srinivasan,Steven G. White,Peggy Winters-Digiacinto,Susan Wong,Wen Zhou,Robert J. Etches +28 more
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TLDR
The ability of upstream and downstream DNA sequences of ovalbumin, a protein produced exclusively in very high quantities in chicken egg white, to drive tissue-specific expression of human mAb in chicken eggs is examined.Abstract:
The tubular gland of the chicken oviduct is an attractive system for protein expression as large quantities of proteins are deposited in the egg, the production of eggs is easily scalable and good manufacturing practices for therapeutics from eggs have been established. Here we examined the ability of upstream and downstream DNA sequences of ovalbumin, a protein produced exclusively in very high quantities in chicken egg white, to drive tissue-specific expression of human mAb in chicken eggs. To accommodate these large regulatory regions, we established and transfected lines of chicken embryonic stem (cES) cells and formed chimeras that express mAb from cES cell-derived tubular gland cells. Eggs from high-grade chimeras contained up to 3 mg of mAb that possesses enhanced antibody-dependent cellular cytotoxicity (ADCC), nonantigenic glycosylation, acceptable half-life, excellent antigen recognition and good rates of internalization.read more
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Journal ArticleDOI
Formulation and delivery issues for monoclonal antibody therapeutics
TL;DR: Technical challenges in the formulation of antibody-based materials to maintain sufficient stability in a variety of configurations and sometimes at particularly high concentrations are reviewed.
Journal ArticleDOI
Heterogeneity of Monoclonal Antibodies
TL;DR: The current knowledge of enzymatic and nonenzymatic modifications of monoclonal antibodies including the common ones such as incomplete disulfide bond formation, glycosylation, N-terminal pyroglutamine cyclization, C- terminal lysine processing, deamidation, isomerization, and oxidation are reviewed.
Journal ArticleDOI
Glycan optimization of a human monoclonal antibody in the aquatic plant Lemna minor
Kevin M. Cox,Jason D. Sterling,Jeffrey T. Regan,John R. Gasdaska,Karen K Frantz,Charles G. Peele,Amelia Black,David Passmore,Cristina Moldovan-Loomis,Mohan Srinivasan,Severino Cuison,Pina M. Cardarelli,Lynn F. Dickey +12 more
TL;DR: The expression of human mAbs in the small aquatic plant Lemna minor offers several advantages for manufacturing therapeutic proteins free of zoonotic pathogens and had better antibody-dependent cell-mediated cytotoxicity and effector cell receptor binding activities than mAbs expressed in cultured Chinese hamster ovary (CHO) cells.
Journal ArticleDOI
Germline transmission of genetically modified primordial germ cells.
Marie-Cecile van de Lavoir,Jennifer H. Diamond,Philip A. Leighton,Christine Mather-Love,Babette S. Heyer,Renee Bradshaw,Allyn Kerchner,Lisa T. Hooi,Terri M. Gessaro,Susan E. Swanberg,Mary E. Delany,Robert J. Etches +11 more
TL;DR: It is shown that chicken PGCs can be isolated, cultured and genetically modified while maintaining their commitment to the germ line, and that they can be induced in vitro to differentiate into embryonic germ cells that contribute to somatic tissues.
Journal ArticleDOI
Biopharmaceutical benchmarks 2006
TL;DR: The rate of biopharmaceutical approvals has leveled off, but some milestones bode well for the future.
References
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Efficient selection for high-expression transfectants with a novel eukaryotic vector
TL;DR: The results showed that high concentrations of G418 efficiently yielded L cell and CHO cell transfectants stably producing IL-2 at levels comparable with those previously attained using gene amplification.
Journal ArticleDOI
Inhibitory Fc receptors modulate in vivo cytotoxicity against tumor targets.
TL;DR: It is demonstrated that Fc-receptor-dependent mechanisms contribute substantially to the action of cytotoxic antibodies against tumors and indicate that an optimal antibody against tumors would bind preferentially to activation Fc receptors and minimally to the inhibitory partner FcγRIIB.
Journal ArticleDOI
Lack of Fucose on Human IgG1 N-Linked Oligosaccharide Improves Binding to Human FcγRIII and Antibody-dependent Cellular Toxicity
Robert L. Shields,Jadine Lai,Rodney G. Keck,Lori Y. O'Connell,Kyu Hong,Y. Gloria Meng,Stefanie Weikert,Leonard G. Presta +7 more
TL;DR: Antibody-dependent cellular cytot toxicity assays using purified peripheral blood monocytes or natural killer cells from several donors showed enhanced cytotoxicity, especially evident at lower antibody concentrations.
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The absence of fucose but not the presence of galactose or bisecting N-acetylglucosamine of human IgG1 complex-type oligosaccharides shows the critical role of enhancing antibody-dependent cellular cytotoxicity.
Toyohide Shinkawa,Kazuyasu Nakamura,Naoko Yamane,Emi Shoji-Hosaka,Yutaka Kanda,Mikiko Sakurada,Kazuhisa Uchida,Hideharu Anazawa,Mitsuo Satoh,Motoo Yamasaki,Nobuo Hanai,Kenya Shitara +11 more
TL;DR: The results indicate that the lack of fucosylation of IgG1 has the most critical role in enhancement of ADCC, although several reports have suggested the importance of Gal or bisecting GlcNAc and provide important information to produce the effective therapeutic antibody.
Journal ArticleDOI
The production of recombinant pharmaceutical proteins in plants.
TL;DR: Molecular farming in plants has already proven to be a successful way of producing a range of technical proteins and the first plant-derived recombinant pharmaceutical proteins are now approaching commercial approval, and many more are expected to follow.