Khan Imran, Daniell Henry
Department of Basic and Translational Sciences, School of Dental Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.
Curr Opin Colloid Interface Sci. 2021 Aug;54. doi: 10.1016/j.cocis.2021.101452. Epub 2021 Mar 24.
Oral delivery of protein drugs (PDs) made in plant cells could revolutionize current approaches of 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. 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 role of GALT in inducing tolerance facilitate prevention or treatment allergic, autoimmune diseases or anti-drug antibody responses. Delivery of functional proteins facilitate 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 cGMP facilities, IND enabling studies for clinical advancement and FDA approval of orally delivered PDs augur well for advancing this novel drug delivery platform technology.
口服植物细胞生产的蛋白质药物（PDs）可能会彻底改变目前其生产和递送的方法。PDs的表达通过消除极其昂贵的发酵、纯化、冷藏运输/储存以及无菌注射，降低了生产成本，并将其保质期延长数年。植物细胞壁保护PDs免受消化酸/酶影响的能力、共生细菌在植物细胞壁裂解后在肠腔中释放PDs的能力以及肠道相关淋巴组织（GALT）在诱导耐受性方面的作用，有助于预防或治疗过敏性、自身免疫性疾病或抗药物抗体反应。功能性蛋白质的递送有助于治疗遗传性或代谢性疾病。在可食用植物细胞中使PDs不含抗生素抗性基因、在常温下长期储存以保持其疗效、在符合cGMP标准的设施中生产、开展支持IND申请以推进临床试验以及FDA批准口服PDs等方面的最新进展，预示着这一新型药物递送平台技术将取得良好进展。
