Oral delivery of therapeutic proteins bioencapsulated in plant cells: Preclinical and clinical advances |
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Affiliation: | 1. School of Pharmacy, China Pharmaceutical University, Nanjing 211198, China;2. Department of Geriatrics, The Second Affiliated Hospital, Nanjing Medical University, Nanjing 210011, China;3. Key Laboratory for Aging & Disease, Nanjing Medical University, Nanjing 210011, China;4. Jiangsu Aosaikang Pharmaceutical Co., Ltd., Nanjing 211112, China;5. Department of Respiratory Disease, Baoshan Branch, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200120, China;6. Department of Geriatric Cardiology, Jiangsu Provincial Key Laboratory of Geriatrics, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China;7. Department of Geriatrics, The Affiliated Sir Run Run Hospital of Nanjing Medical University, Nanjing 211166, China |
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Abstract: | Oral delivery of protein drugs (PDs) made in plant cells could revolutionize current approaches to their production and delivery. Expression of PDs reduces their production cost by elimination of prohibitively expensive fermentation, purification, cold transportation/storage, and sterile injections and increases their shelf life for several years. The ability of plant cell wall to protect PDs from digestive acids/enzymes, commensal bacteria to release PDs in gut lumen after lysis of plant cell wall, and the role of gut-associated lymphoid tissue in inducing tolerance facilitate prevention or treatment of allergic, autoimmune diseases or antidrug antibody responses. The delivery of functional proteins facilitates treatment of inherited or metabolic disorders. Recent advances in making PDs free of antibiotic resistance genes in edible plant cells, long-term storage at ambient temperature maintaining their efficacy, production in Current Good Manufacturing Practice (cGMP) facilities, Investigational New Drug (IND)-enabling studies for clinical advancement, and Food and Drug Administration approval of orally delivered PDs augur well for advancing this novel drug delivery platform technology. |
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Keywords: | Molecular farming Chloroplast Protein drugs Oral tolerance Transplastomic plants Autoimmune diseases Metabolic disorders |
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