title: Large-scale production of pharmaceutical proteins in plant cell culture-the Protalix experience.
abstract: Protalix Biotherapeutics develops recombinant human proteins and produces them in plant cell culture. Taliglucerase alfa has been the first biotherapeutic expressed in plant cells to be approved by regulatory authorities around the world. Other therapeutic proteins are being developed and are currently at various stages of the pipeline. This review summarizes the major milestones reached by Protalix Biotherapeutics to enable the development of these biotherapeutics, including platform establishment, cell line selection, manufacturing process and good manufacturing practice principles to consider for the process. Examples of the various products currently being developed are also presented.
authors.affiliation: Protalix Biotherapeutics, Carmiel, Israel.
authors.forename: Yoram
authors.initials: Y
authors.lastname: Tekoah
authors.affiliation: Protalix Biotherapeutics, Carmiel, Israel.
authors.forename: Avidor
authors.initials: A
authors.lastname: Shulman
authors.affiliation: Protalix Biotherapeutics, Carmiel, Israel.
authors.forename: Tali
authors.initials: T
authors.lastname: Kizhner
authors.affiliation: Protalix Biotherapeutics, Carmiel, Israel.
authors.forename: Ilya
authors.initials: I
authors.lastname: Ruderfer
authors.affiliation: Protalix Biotherapeutics, Carmiel, Israel.
authors.forename: Liat
authors.initials: L
authors.lastname: Fux
authors.affiliation: Protalix Biotherapeutics, Carmiel, Israel.
authors.forename: Yakir
authors.initials: Y
authors.lastname: Nataf
authors.affiliation: Protalix Biotherapeutics, Carmiel, Israel.
authors.forename: Daniel
authors.initials: D
authors.lastname: Bartfeld
authors.affiliation: Protalix Biotherapeutics, Carmiel, Israel.
authors.forename: Tami
authors.initials: T
authors.lastname: Ariel
authors.affiliation: Protalix Biotherapeutics, Carmiel, Israel.
authors.forename: Svetlana
authors.initials: S
authors.lastname: Gingis-Velitski
authors.affiliation: Protalix Biotherapeutics, Carmiel, Israel.
authors.forename: Uri
authors.initials: U
authors.lastname: Hanania
authors.affiliation: Protalix Biotherapeutics, Carmiel, Israel.
authors.forename: Yoseph
authors.initials: Y
authors.lastname: Shaaltiel
mesh_terms: D019149:Bioreactors; D018929:Cell Culture Techniques / Q000379:methods*; D004345:Drug Industry; D006031:Glycosylation; D006801:Humans; D059828:Plant Cells / Q000378:metabolism*; D011994:Recombinant Proteins / Q000096:biosynthesis* / Q000276:immunology
chemical_list: D011994:Recombinant Proteins
keywords: Protalix Biotherapeutics; enzyme replacement therapy; molecular farming; oral delivery; plant cell culture; β-glucocerebrosidase