32 GHP Biotechnology Awards 2023 Based in Beijing, China, biopharmaceutical company, Allife Medicine Inc is a clinicalstage company specialising in cellular medicine. The company has established itself as a leader in the development and manufacture of off-the-shelf universal cell products using its induced pluripotent stem cell (iPSC) platform. Until 2006, science was still under the assumption that specific cells were only able to produce cells of the same type, for example, blood cells could only create blood cells. But in that year, ground-breaking research by Japanese scientist, Professor Shinya Yamanaka, showed otherwise. And, in 2007, a team at the Broad Stem Cell Research Center at UCLA created the world’s first human iPSC. Similar to wiping the hard drive of a computer, scientists reprogramme blood and skin cells, back to an embryonic-like pluripotent state. They are then ready to take on a new function. The process generates ‘blank’ cells ready for use in the treatment of diseases such as cancer, diabetes, and neurological disorders. Allife Medicine focuses on the research and application of this regenerative medicine technology. The new-generation pharmaceutical enterprise dedicates its time and resources to the prevention and effective treatment of major human diseases. Having mastered the world’s most advanced iPSC induced pluripotent stem cell technology, Allife Medicine’s goals are to use its skills and technology to improve health and prolong life. Talking about current initiatives, company spokesperson Qi Rui, says, “At present, our pipeline of self-developed cell therapy products includes iEPC for acute stroke, CAR-iNK for cancer, drugs for type 1 diabetes, and dry AMD. Of these, two products are being evaluated in Phase 1 clinical trials. We’ve been carrying out joint research and clinical cooperation with lots of first-class hospitals and well-known experts in the field in China.” Allife Medicine’s collaborators include the University of Cambridge and Aston University in the UK, the Wellcome Trust Sanger Institute, Peking University, and the Beijing Cancer Hospital. When asked about the research challenges facing the company, Qi Rui explains, “There are three inherent characteristics of iPSC cells – tumorigenicity, immunogenicity, and heterogeneity. They are also our three major challenges in the application of iPSC cells. At the moment, the issues with differentiating iPSC into NK (natural killer) cells are multiple. The low yield of NK cells, the imperfect killing function of differentiated NK cells, and the difficulty in standardising large-scale production and transformation are all challenges we are committed to overcoming. Our intention is to develop a new method of in vitro NK cell differentiation with good tumour-killing activity, and a process for industrial production. So far, we’ve made great progress in solving these problems.” Following legislation issued by the State Food and Drug Administration, Allife Medicine’s iPSC products all adopt the model of allogeneic bank construction. Cells are divided between two banks: a main bank and a working cell bank. In line with GMP Appendix - Cell Therapeutic Products, Technical Guidelines for Clinical Trials of Human Stem Cells and their derived Cell Therapeutic Products, the company has established a full quality inspection and control system. On how Alllife Medicine differentiates itself in the market, Qi Rui tells us, “Our system includes both internal and external inspections. The main cell bank contains 23 test indicators, and the working cell bank contains 28 test indicators. As a whole, it can be divided into safety indicators, identification indicators, iPSC stemness, iPSC pluripotency, and activity indexes.” Being prepared from individual adult cells, iPSC presents no ethical risk. With an unlimited supply of raw materials, the possibilities for application seem endless. We’re sure to see Allife Medicine achieve its aim to begin production of affordable highquality, multi-variety cell drugs on a large scale in the near future. Contact: Qi Rui Company: Allife Medicine Inc Web Address: http://www.allifetech.com/ Best Stem Cell BioTech Company 2023 - China Jan23456
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