Development of a Scalable Manufacturing Process for a Novel Oral Infliximab Product using the Soteria Technology

尽管英夫利昔单抗单克隆抗体（mAb）被认为是治疗英国30万炎症性肠病（IBD）患者的金标准，但这种化合物只能通过不方便且经常疼痛的注射来给药。这样，只有不到1%的药物到达疾病部位，限制了治疗的效果，同时引起广泛的严重副作用。Intract Pharma的新型给药技术Soteria允许英夫利昔单抗口服给药，从而创造出更有针对性的IBD治疗方法。通过与流程创新中心（CPI）、Quay Pharmaceuticals和Pharmidex的合作，Intract Pharma将开发、优化和验证一种制造工艺，使单克隆抗体能够被配制成口服固体剂型，进而为Soteria创建一个符合gmp的制造方案。到目前为止，单抗疗法尚未能够以临床和商业上可行的方式生产口服给药。因此，该项目将在药物配方领域开发新的创新制造方法，特别是在抗体稳定和配方方面。因此，该项目不仅将在抗体配方方面开辟新天地，而且还将进一步开发一种治疗方法，可以极大地改善IBD患者的治疗。

Though the monoclonal antibody (mAb), infliximab, is considered a gold-standard treatment for the 300,000 patients in the UK with inflammatory bowel disease (IBD), the compound can only be administered through an inconvenient and often painful injection. In doing so, only less than 1% of the drug reaches the site of disease, limiting the efficacy of the treatment whilst causing a wide range of serious side-effects. Intract Pharma's novel drug delivery technology, Soteria, allows for infliximab to be administered orally, creating a more targeted IBD treatment. In partnership with the Centre for Process Innovation (CPI), Quay Pharmaceuticals and Pharmidex, Intract Pharma will develop, optimise and validate a manufacturing process that enables mAbs to be formulated as an oral solid dosage form, and in turn create a GMP-ready manufacturing protocol for Soteria. So far, mAb therapies have not yet been able to be manufactured for oral administration in both a clinically and commercially viable manner. Therefore, the project will develop new innovative manufacturing approaches in the field of pharmaceutical formulation, particularly with regards to antibody stabilisation and formulation. As a result, this project will not only break new ground in antibody formulation but further develop a therapeutic that could vastly improve the treatment of patients with IBD.