PFSmanufacturingprocessforbiotech生物制剂用预灌封注射.PDF

PFS manufacturing process for biotech 生物制剂用预灌封注射器 制造工艺 Alessandro Morandotti, Product Manager Syringes 欧璧注射器产品经理 Alessandro Morandotti CNPPA，2016 年 9 月 9 日 Outline 大纲 • Market overview (up to date and in the next 5 years) 市场概览 （最新及未来5 年） • Market evolution 市场发展 • Syringe Segmentation 注射器细分 • Injectable trend 注射剂趋势 • PFS and sensitive drugs: 预灌封注射器和敏感药物： • Existing technical challenges aspect to be considered during development of PFS:预充针开发过程中要考虑的现有技术难题： • Silicone treatment (silicone quantity and components selection) 硅化处理（硅油量和配件选择） • Autoinjectors integration 自动注射笔适配组装 • New option for high sensitive drugs 高敏感药物的新选择 • State of the art manufacturing process and control strategy 尖端制造工艺与控制策略 2 Trends: injectables blockbuster 趋势：注射剂迅速发展 注射剂需求至2018年均复合增长率达4%-7% 3 Worldwide Market Trend on Injectable Drugs 注射剂药物全球市场趋势 +3 bn of More PFS on the Self-Administration safety market 自我给药 更加 市面现有 安全 +30 亿 预充针 PFS are widely used for Responsibilities are transferred Increasing standards are administering vaccines, to Patient or Caregiver driving demand for high heparin, biotech drugs (easy-of use and compliance quality products also in 预充针广泛用于疫苗、肝素 as consequence) emerging markets 和生物技术药物给药 职责转移至患者或看护人员