PDF《斯蒂瓦那托 集团》

An integrated solution for combination products: The Stevanato Group'

s 4D Approach 组合产品解决方案: 斯蒂瓦那托集团的4D方法 Qing Li qing.

li@stevanatogroup.com CNPPA 2019, XXX, CN | April XXXX,

2019 CNPPA 2019年XXX,CN | 2019年4月XXXX 斯蒂瓦那托 集团 Evolution of SG: Challenges &

opportunities we see in the market today SG的演变:当今市场上我们面临的挑战与机遇 OMPI EZ fill Nexa &

Alba PFS support for AI, Cartridge support for Pen/AI/Wearables, CS: Sorrel Medical, CS: Sterile fluid path support for wearables EZ fill Nexa &

Alba PFS 支持AI,卡式瓶支持笔式注射器/AI/穿戴式注射器,CS:Sorrel Medical,CS:无菌流体路径支持穿戴式设备 BALDA The importance of working well with consultants 与顾问良好合作的重要性 CS: Medirio 1ml wearable and EZ Link vial adaptor CS: Medirio 1ml 穿戴式注射器和EZ Link西林瓶接头 SVM Hybrid assembly equipment for various devices such as injection systems &

inhalers 用于各种设备的混合封装设备,如注射系统和吸入器 Key learning &

the desire to strengthen collaboration with 4D 学习要点以及加强与4D合作的愿望 The starting point 起点:

3 The starting point 起点: Zhangjiagang 张家港 Zhangjiagang | Sales Office 张家港 | 销售办事处 On 8th October 2017, the last day of China'

s Gold Week holiday, the General Office of the CPC Central Committee and the General Office of the State Council issued The Opinions on Deepening the Reform of Review and Approval Systems to Encourage Innovation of Drugs and Medical Devices . On an expanded basis, this document is the official outcome of the CFDA'

s draft regulation series on drugs and medical devices. 2017年10月8日,也就是中国国庆黄金周的最后一天,中共中央办公厅和国务院办公厅印发了 《关于深 化审评审批制度改革鼓励药品医疗器械创新的意见》.经过扩大范围,本文件成为CFDA关于药品和医疗 器械的一系列法规草案的官方结果. The goal of this new guideline is to stimulate the vitality of pharmaceutical research and development, improve innovation and address the shortage issues of drugs and medical devices so that patients can access life-saving medications as soon as possible. 这一新指南的目标是:激发药品研发的活力,提高创新能力和 解决药品和 医疗器械的短缺问题,从而 患者能尽快获得挽救生命的药物. This is the most important policy in the history of China'

s pharmaceutical industry since the foundation of the People'

s Republic of China 这是中华人民共和国成立以来 中国制药业历史 上 最重要的政策 . Note for the translator C The above article also got the following Chinese translation: 《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》 Delete this box after the translation Container Quality 容器质量 Easy to Use 简单易用 Flexibility 灵活 The NEW Chinese Policy 中国的新政策

4 The Four Dimensions Approach for Combination Products 组合产品 的四维方法 Pharmaceutical Systems 制药系统 Engineering Systems 工程系统 Services 服务 Engineering Drug Delivery Systems (DDS) 药物递送系统(DDS) 药物递送系统(DDS S) (DDS Pharmaceutical 制5Integrated solution provider for devices 设备的集成解决方案提供商 Glass primary Packaging 初级玻璃 包装 Contract Manufacturing 合同 解决方案 Proprietary device Solutions 专门设备 解决方案 解决方案 包装

6 Auto injectors: 自动注射器: EZ-fill? Nexa?

1 ml, 2.25 ml syringe EZ-fill? Nexa?

1 ml, 2.25 ml 注射器 EZ-fill? Alba? Specifically for each device, from ISO standard containersto a variety of enabling design option 专门用于各种设备,从ISO标准容器到各种 启用式 设计选项 Pen injectors: 笔式注射器: EZ-fill? cartridge range EZ-fill? 卡式瓶系列 Wearables: 穿戴式注射器: EZ-fill? Product range: cartridge, X-cartridge?, special formats EZ-fill? 产品系列:卡式瓶, X-cartridge?,专用格式 Ompi: Glass primary container compatibility &

flexibility for devices Ompi:设备的初级玻璃容器的兼容性与灵活性 Aggiungere riferimento a flaconi EZ-fill

7 Wearable devices: a typical design/construction 穿戴式设备:典型设计/结构 Drive System 驱动 系统 Needle Insertion System 针头 插入 系统 Control System 控制系统 Drug Container System 药物容器系统 Container Closure System 容器 封口 系统 SC Needle SC针头 Main Body/Case 主体/外壳 WearableInjectionDevices 穿戴式注射设备 Needle Insertion System Drug Container System 药物容器系统 Closure System 容器 封口 系统 Fluid Path 流体 通道 Sterile Connector 无菌 连接器 Case study: Supporting wearable devices by leveraging integration of CCS with sterile connector &

fluid path 案例研究:利用CCS与无菌连接器和流体通道的集成,支持穿戴式设备

8 …with integrated Sterile Connector &

Fluid Path… …借助集成无菌连接器和 液路… ..with customized EZ-fill Container Closure Systems… …借助 定制 EZ-fill容器密 封系统… Case study: Supporting wearable devices by leveraging integration of CCS with sterile connector &

fluid path 案例研究:利用CCS与无菌连接器和流体通道的集成,支持穿戴式设备 …with NESTED solutions for easy integration in fill/finish processes. …借助巢式解决方案,可轻松集成到 灌装/封口过程中. ? Preserves sterilityprior to use/使用前保持无菌性 ? Couples fluid path to container/将液路连接到容器 ? Avoids aseptic device assembly/避免无菌装置组装 ? Avoids loading by the patient/无需患者装药

10 11 不同应用 胰岛素和自动注射笔 该组件由以下部件组成: 各种医疗器械 吸入器

12 Integrated solution provider for devices 设备的集成解决方案提供商 Glass primary Packaging 初级玻璃 包装 Contract Manufacturing 合同 解决方案 Proprietary device Solutions 专门设备 解决方案 解决方案 初级玻璃 包装 解决方案

13 西林瓶接头 13mm和20mm两种版本 用针代替塑料钉 获专利权的安全片 鲁尔锁接头 生产 经验证的多腔工具 自动组装设备 EZ-LINK EZ-LINK 特点 特 监管 CE认证标志 经FDA批准的510(K) Case Study: Partnership built on collaboration 案例研究:基于合作的伙伴关系 概览

14 Case Study: Partnership built on collaboration 案例研究:基于合作的伙伴关系

15 Integrated solution provider for devices 设备的集成解决方案提供商 Glass primary Packaging 初级玻璃 包装 Contract Manufacturing 合同 解决方案 Proprietary device Solutions 专门设备 解决方案 解决方案 初级玻璃 包装 解决方案

16 Adjustable Personalized Regimens

17 可调整的个性化方案: 2019年Pharmapack奖获得者 药物输送设备的最佳创新 每年,最具创新力的公司竞相争取Pharmapack 奖项.这些著名奖项旨在表彰那些将塑造行业未来的新产品. 斯蒂瓦那托集团的基于卡式瓶的穿戴式设备 我们基于卡式瓶的穿戴式设备是一种易用、小巧并且可 轻松调节的设备,是一种可替代传统笔式注射器的更好选择.由于采用创新而简单的技术,确保 了无痛,直观和快速给药. 该设备被设计成一种小巧、使用舒适和实用的设备,使患者生活更轻松,即使在运动时也一样. 旅行、运动或者仅仅只是享受当下生活,一切从未如此简单.

19 Key Learnings and Recommendations 学习 要点和建议 -we need greateropenness and increasedcommunication on primary container needs as they relate to the drug, device and expected timelines [eg. Set up

3 way CDA'

s at the start to save time and map out goals with a shared gantt chart where possible, what is on the critical path?] - 由于涉及药品、设备和预期的时间,所以我们需要在初级容器上 扩大开放和增强交流[如: 在开始时设置3种方式的CDA以节省时间,并在可能的情况下使用共享的甘特图来制定目标,主 要途径是什么?] -establishtherules of engagement between the partners at an early stage [eg. who owns developed IP during programs?] - 在初期阶段制定合作伙伴间的合作规则 [如:程序中,开发的IP属于谁?] -meet regularlywithkey partners [eg. JSC or executive involvement promotes faster decision making and also allows us to find ways to better anticipate the needs of biopharma/partners] -定期与主要合作伙伴会面 [如:JSC或高管参与可以促进决策的加快,同时也使我们找到方法, 以更好地预测生物制药或合作伙伴的需求] -look for opportunities to useflexibleequipmentfor more than one device or type of device [eg. we see test equipment that can be used for several devices, we can see the trend for this also in final assembly equipment and even some subassembly equipment -寻找机会,将 柔性装备 用于多个或多种设备[如:我们发现测试设备可用于多种设备,发现 该测试设备还可用于总装设备甚至某些子装配设备中 An integrated solution for combination products: The Stevanato Group'

s 4D Approach 组合产品解决方案:斯蒂瓦那托 集团的4D方法 Steven Kaufman, VP Drug Delivery Systems Steven Kaufman, 药物递送系统副总裁 steven.kaufman@stevanatogroup.com DDP 2019, Palm Beach, FL | January 28-30,

2019 DDP 2019,美国佛罗里达州棕榈滩 | 2019年1月28-30日 斯蒂瓦那托 集团 ........