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细胞疗法正在积极发展，并有望治疗多种疾病适应症. However, 在这些治疗药物的制造过程中，存在直接和长期的挑战，这些挑战会造成障碍. In response, we have pursued collaboration and innovation, 确保最好的机会带来细胞疗法, and one day even cures, to the patients who need it most.
Cell therapies 目前是否正在开发旨在阻止和逆转疾病的药物, restore damaged organs, and ultimately, cure many life-threatening conditions. We aim to do this by placing new, 健康的细胞进入身体以取代患病或受损的细胞, 或者通过使用免疫细胞去除引起疾病或功能失调的细胞.
尽管这些疗法代表着巨大的机会, 澳门第一赌城在线娱乐需要能够将研究发现转化为临床级产品, and in such a novel and continuously evolving field, this can add additional challenges. Like a tangled web, biological, 制造和监管挑战密切相关，需要在整个细胞产品交付过程中有效地进行导航.
Cell therapy manufacturing process
- Choose starting materials and adequate reagents
- Assess feasibility of production and expansion
- Assess viability and functionality of product
- Define ways to characterise and release the final product
- Assess feasibility of master and working cell banks
- Identify activity and safety of product
- Define how the product will be stored, shipped and delivered to the patient
细胞治疗制造工艺不断改进，以提高产品产量, batch size, purity, reproducibility, 效力和稳定性，同时努力减少生产时间和成本.
Key challenges with cell therapy manufacturing
制造过程介于细胞疗法的研究和最终将这些药物交付给患者之间. As part of the manufacturing process, we need to consider both ends of product development, including biological and regulatory needs. For instance, early in the research phase, 科学家必须分离出正确的细胞类型，并确定其作用机制，以确保细胞治疗具有预期的特征. 确定这种作用方式需要广泛的研究和使用特定的测定方法，以创造一种可以安全交付给患者并获得监管机构批准的有效产品.
Like other drug modalities, 细胞疗法也受到当前药物产品大规模面临的既定挑战的影响. To reach millions of patients, drug products need to be produced at scale, depending on the process and disease that is targeted. 这些工艺也需要同时改进以提高产量, batch size, purity, reproducibility and potency. 但细胞疗法也有其独特的挑战. Due to their novelty, 它们的生产通常需要使用非常规原材料，这可能导致产品供应不一致, 以及与低温储存和运输相关的物流问题. 处理这些材料的人员通常也需要专门培训.
利用患者自身细胞制造细胞疗法面临着额外的挑战，那就是要遵守一个紧凑的制造时间表. This type of cell therapy, needs cells to be collected from a patient, biologically altered, 并在短时间内移植回病人体内, the goal is to go from vein to vein in just 21 days. 为了实现这一目标，并优化所有细胞疗法的开发和制造, 规模化和商业化是与产品开发并行考虑的, sometimes even before the first dose is made.
Cell therapy manufacturing bridges disease areas
细胞治疗是一个具有独特物流和制造挑战的新领域, 但澳门第一赌城在线娱乐将继续投资于应对这些挑战的流程和方法. Specifically, 澳门第一赌城在线娱乐在现有的生物制造基础设施的基础上，欢迎具有特定技能的有才华的细胞治疗科学家, alongside partnering with academic, non-academic and cell industrialisation centres. In addition, 澳门第一赌城在线娱乐正在投资建设专门的设施，以支持早期细胞治疗产品的开发和制造.
从心脏病发作后修复受损的心脏细胞到修改患者自身的T细胞以靶向实体肿瘤, 澳门第一赌城在线娱乐为澳门第一赌城在线娱乐的进步感到自豪，并有信心在未来五到十年, 细胞疗法将有助于改善当今一些最严重和限制生命的疾病患者的前景.
