写的:
细胞疗法 are actively being developed 和 hold great promise to treat a multitude of disease indications. 然而, there are immediate 和 long-term challenges that create obstacles during the manufacturing process of these therapeutics. 在回应, 澳门第一赌城在线娱乐坚持合作创新, ensuring the best chance of bringing cell-based treatments, 有一天甚至会痊愈, 给最需要的病人.
细胞疗法 are currently in development with the aim to halt 和 reverse disease, 修复受损器官, 并最终, 治疗许多危及生命的疾病. 澳门第一赌城在线娱乐的目标是通过放置新的, healthy cells into the body to replace diseased or damaged ones, or by removing disease causing or dysfunctional cells using immune cells.
Though these treatments represent a tremendous opportunity, we need to be able to turn research discoveries into clinical grade products, 在这样一个新颖且不断发展的领域, 这可能会增加额外的挑战. 像一张纠结的网, 生物, manufacturing 和 regulatory challenges are intimately connected 和 these need to be effectively navigated throughout the cell product delivery process.
细胞治疗制造工艺
- 选择 起始原料 和 适当的试剂
- 评估…的可行性 生产 和 扩张
- 评估 生存能力 和 功能 的产品
- 定义方法 描述 和 释放 最终产品
- 评估…的可行性 主 和 工作细胞库
- 识别 活动 和 安全 的产品
- 定义产品将会是什么样子 存储, 运 和 交付给病人
The cell therapy manufacturing process is continually refined to increase product yield, 批量大小, 纯度, 再现性, potency 和 stability while striving to decrease manufacturing time 和 cost.
细胞治疗制造的主要挑战
Manufacturing st和s between the research of cell therapies 和 the eventual delivery of these medicines to patients. 作为制造过程的一部分, 澳门第一赌城在线娱乐需要考虑产品开发的两个方面, 包括生物和调控需求. 例如, 在早期的研究阶段, scientists must isolate the correct cell type 和 determine its mechanism of action to ensure the cell therapy has the intended profile. Determining this mode of action requires extensive research 和 use of specific assays to create an efficacious product that can be delivered safely to patients 和 be approved by regulatory authorities.
和其他药物一样, cell therapies are also affected by well-established challenges that current drug products face on a large-scale. 惠及数百万患者, 药品需要大规模生产, 取决于所针对的过程和疾病. The processes also need to be refined simultaneously to increase the yield, 批量大小, 纯度, 可重复性和效力. But cell therapies also bring their own unique set of challenges. 由于它们的新奇性, their 生产 typically requires the use of non-conventional raw materials which may result in an inconsistent supply 的产品s, along with issues related to logistics surrounding low-temperature storage 和 shipping. Personnel also often require specialised training to h和le these materials.
Manufacturing cell therapies that utilise a patient’s own cells have the additional challenge of adhering to a condensed manufacturing timeline. 这种类型的细胞疗法, 需要从病人身上采集细胞, 生理改变, 和 transplanted back to the patient in a short window – right now, 目标是在21天内从一条静脉移植到另一条静脉. To achieve this 和 optimise the development 和 manufacturing of all cell therapies alike, scaling 和 commercialisation are considered in parallel with product development, 有时甚至在第一次注射之前.
细胞治疗制造是疾病领域的桥梁
Cell therapy is a new space with unique logistic 和 manufacturing challenges, but we continue to invest in processes 和 approaches to address these challenges. 具体地说, we are building on our existing 生物 manufacturing infrastructure by welcoming talented cell therapy scientists with specific skill sets, 除了与学术机构合作, 非学术和细胞工业化中心. 除了, we are investing in building specialised facilities to support early cell therapy product development 和 manufacturing.
From repairing damaged cardiac cells in the heart after heart attack to modifying a patient’s own T cells to target solid tumours, we are proud of our progress 和 confident that in the next five to 10 years, cell therapy will help improve the outlook for patients with some of today’s most serious 和 life limiting diseases.
