Build & Validate | Tailor Made | Biopharmaceutical Knowledge | Manufacturing Facilities & Systems.

Presentation on theme: "Build & Validate | Tailor Made | Biopharmaceutical Knowledge | Manufacturing Facilities & Systems."— Presentation transcript:

1 Build & Validate | Tailor Made | Biopharmaceutical Knowledge | Manufacturing Facilities & Systems

2 www.Biopharmax.com About Us 关于我们 Biopharmax is a global leading design and construction group specializing in the Biopharmaceutical market segment. Biopharmax 是一家专注于生物医药市场的全球领先设计和施工集团。 The Group provides tailor made turnkey solutions for Biotechnological, API and Pharmaceutical manufacturing facilities. 本集团为生物技术、 API 原料药和医药生产设施提供定制交钥匙解决方案。 For 40 years Biopharmax caters industry leaders and accumulated hundreds of projects references designed and built all over the world. 四十多年来， Biopharmax 为行业领先者提供设计和施工服务，在全球积累了数百个示例工程。 On time! 按工期！ On budget! 按预算！ No compromises on results! 按质量！

3 www.Biopharmax.com Mission 使命 Design, Build & Validate Tailor-Made 设计，建造 & 验证 Biopharmaceuticals 专业定制 Manufacturing Plants 生物医药生产厂房 Design, Build & Validate Tailor-Made 设计，建造 & 验证 Biopharmaceuticals 专业定制 Manufacturing Plants 生物医药生产厂房

4 www.Biopharmax.com Complete Process Delivery 完整工艺交付 URS 用户需求 Conceptual Design 概念设计 Cost Estimation 成 本估算 Detailed Engineering 详细工程设计 Procurement 采购 Construction & Commissioning 建 造 & 试运行 Validation 验证 Handover of operating plant 操 作厂房移交

5 www.Biopharmax.com Applications 应用 Your partner for Design, Constructions, Delivery & Validation 您的设计、建造、交付 & 验证合作伙伴

6 www.Biopharmax.com Worldwide Activities 全球业务分部  Nearly 200 engineers, programmers and technicians with divers experience in niche segment 在专业领域里拥有近 200 名不同专业的具有丰富经验的工程师、程序员和技术人员  Headquarter offices in 4 courtiers: Israel, India, China and Netherlands 在以色列，印度，中国和荷兰四国设有分部  Successfully delivering hundreds of projects in nearly 20 countries worldwide 在全球近 20 个国家成功移交数百工程 Italy Netherlands Mexico Singapore Canada USA Hungary NC NJ CA Turkey Israel Ireland China Romania India Puerto Rico

7 Group Structure 组织结构 Private Holding Company 私人控股 Private Holding Company 私人控股 Biopharmax Inc USA 美国 Biopharmax Inc USA 美国 Pharma Project Asia Ltd Hong Kong 香港 Pharma Project Asia Ltd Hong Kong 香港 Biopharmax BV The Netherlands 荷兰 Biopharmax BV The Netherlands 荷兰 Biopharmax Group Israel 以色列 Biopharmax Group Israel 以色列 www.Biopharmax.com HBPS Ltd. China 中国 HBPS Ltd. China 中国 Biopharmax India India 印度 Biopharmax India India 印度 SAE Netherlands Antilles SAE Netherlands Antilles HBPS – Hefei Biotech and Pharma Services Ltd. 珐玛生物科技服务（合肥）有限公司 SAE – Sterile & Aseptic Equipment

8 www.Biopharmax.com All In House Capabilities 所有室内能力 Architectural 建筑 Process 工艺 Mechanical & Detail Design 机械 & 细化设计 HVAC & Clean Rooms 暖通 & 洁净室 Laboratories 实验室 Software & Control 软件 & 控制 Validation 验证 Procurement & Contract 采购 & 合同 Electrical 电气

9 Process 工艺 Automation 自动化 Validation 验证 www.Biopharmax.com Core Specialties 核心专业 In house programmers and instrumentation 室 内编程和仪表化 Complete integration approach, process utilities, facility 完善的整合方法，工艺设备和设施 Batch automation and records 批量自动化和 记录 Full documentation (FRS, STD, SMDS, FDS) 完整的文档 (FRS, STD, SMDS, FDS) Standards – S88, GAMP5, 21CFR11 标准 -- S88, GAMP5, 21CFR11 DQ – comparison: URS, BOD, Drawings, Specs 设计确认 — 比较： 用户使用说明，设计基础，图纸 ，规格 Commissioning – efficient and thorough IC and OC 调试 — 高效彻底的 IC 和 OC Validation Protocols – GMP based methodology for leverage of commissioning 验证文件 — 基于 GMP 规范的调试手段方法 Computer Validation – Fast and efficient validation with Modular Graphics and Standard PLC Blocks 电脑验证 — 使 用模块图形和标准 PLC 模块进行 迅速高效的验证 Sterile, Aseptic, Bulk 卫生，无菌，批量 Filling, Clean Utilities (PW, WFI, PS, CIP) 灌装，洁 净设备 (PW, WFI, PS, CIP) UP stream/Down stream 上游 / 下游 Mammalian,/ Bacterial/Plant Cells 哺乳类 / 细菌 / 植 物细胞 Fermentation/Batch/Perfusion processes 发酵 / 批处 理 / 灌注工艺 Standards – EU, US, Canadian, Chinese, Indian 标准 — 欧盟，美国，加拿大，中国，印度

10 www.Biopharmax.com Expertise 专长 Ultra filtration systems 超滤过系统 Sterile & Aseptic facilities 无菌设施 Fermentation systems 发酵系统 Bioreactors 生物反应器 PW & WFI 纯化水 & 注射用水 Vessels for media production 介质生产罐 CIP & SIP systems CIP&SIP 系统 Clean rooms & HVAC 洁净室 &HVAC Unique Tailor-Made solutions 独有的定制解决方案

11 Technology Sourcing 技术导入 Recombinant Products 重组产品  Hep-B Vaccine 乙肝疫苗  Insulin 胰岛素  Factor VII VII 因子 Monoclonal Antibodies 单克隆抗体  RETUXIMAB 利妥昔单抗  BEVACIZUMAB 贝伐单抗  TRASTUZUMAB 曲妥珠单抗  ETANERCEPT 依那西普  ADALIMUMAB 阿达木单抗 Carbapenem antibiotics 碳青霉烯类抗生素  Imipenem 亚胺培南  Meropenem 美罗培南  Doripenem 多利培南  Ertapenem 厄他培南 www.Biopharmax.com Blood Products 血液制品  IVIG  ALBUMIN 白蛋白  FACTOR VIII  FACTOR IX / XI IV Solutions 大输液产品  Saline 生理盐水  Dextros 右旋糖  Sodium Lactate (Hartman) 乳酸钠  Ringer Solution 林格液  Darrow Solution 达罗溶液  Mannitol 甘露醇  Sodium Chloride and Glucose 氯化钠和葡萄糖

12 Added Values 附加值 www.Biopharmax.com VMP Block Diagram BOD P&ID’sLayouts Equipment Specs Control Specs MTO/BOM Equipment DQ Tenders/Bids Procurement Construction Installation FAT SSO - Schedule Of System Operation Programming Simulation Start Up of single systems Integration HAND OVER IQ,OQ Commissioning Documentation PQ/SOP’S 3 D PFD URS (Customer) Electrical Design Instrument & Control Design FDA Pre Approval GMP-GEP based methodology for holistic execution of Biopharma projects 以 GMP-GEP 为基础的生物医药项目整体执行方法

13 www.Biopharmax.com Added Values Procurement Department 附加值 采购部门 Economy of scale: costs reduction by global procurement through long term contracts with leading worldwide brands 规模经济：通过与全球领先品牌订立长期采购合同降低成本 Quantities – purchasing for parallel projects 量化 —— 多个并行项目采购 Quality – long term worldwide contracts with key suppliers 质量 —— 全球关键供 应商长期合同 Yearly purchase plan - orders for the coming year main suppliers for major cost saving. 年度采购计划 —— 为大量节约成本，来年主要供应商下单 Rebate – according yearly quantities purchased 折扣 —— 基于每年采购数量

14 Biopharmax in the News 媒体报道 Biopharmax www.Biopharmax.com

15 Awards 奖项 www.Biopharmax.com Biopharmax has been awarded as the ‘Business Performer of the Year-2014’ by Abbott Healthcare. Biopharmax 被雅培保健品公司授予 “2014 年度公司 ”

16 Customers 客户 www.Biopharmax.com

17 Build & Validate | Tailor Made | Biopharmaceutical Knowledge | Manufacturing Facilities & Systems

18 www.Biopharmax.com Fibrin sealant sterile production plant 纤维蛋白无菌生产厂房 Raw material human plasma and cryo 原料人体血浆和冷冻 EMEA compliant 符合 EMEA 要求

19 www.Biopharmax.com  Production lines 生产线  Process equipment 工艺设备  Clean rooms 洁净室  Filling suite, packaging department 灌装间，包装部门  Clean and general utilities 洁净和一般公用设施  Warehouses, laboratories, offices 仓库，实验室，办公室  Complete commissioning and validation 完整的试运行和验证

20 www.Biopharmax.com Appreciation Certificate Grant by J&J Omrix

21 Biotechnology production plant 生物技术生产厂房 Insulin crystals and other recombinant products 胰岛素晶体和其他重组产品 www.Biopharmax.com HTBT

22 www.Biopharmax.com  7,500 SQM building 建筑面积 7500 平方米  Process equipment, fermentors 工艺设备，发酵罐  Upstream, Downstream and final purification 上游，下游和最终纯化  Clean utilities and general utilities 洁净和一般公用设施  Warehouses, laboratories, offices 仓库，实验室和办公 室  Software per CFR21part11 软件按照 CFR 21 部分 11  Complete commissioning and validation 完整试运行和验 证  EMEA compliant 符合 EMEA

23 HTBT www.Biopharmax.com Completion of Handover Ceremony 交付仪式完成 Video

24 www.Biopharmax.com  Detail engineering 详细设计  Process Skids ASME BPE compliant 符合 ASME BPE 要求的工艺模块  Process Piping 工艺管道  CE certified electrical control CE 认 证的电气控制  21 CFR compliant Automation and control 符合 21 CFR 要求的自动 化和控制  Integration of Process Skid paraphernalia Equipment & Utility 工 艺模块全部有关的设备设施的 整合 Process Skids- Feno Penta 工艺模块

25 www.Biopharmax.com Biotech process skids 生物技术工艺模块  Fermentation buffer system 发酵缓冲系统  Preparation vessel 配液罐  Media vessel 介质罐  CaCl2 vessel 氯化钙罐  NH4OH vessel 氨水罐  Buffers distribution system 缓冲液分配系统  CIP  SIP  Automated Control 自动化控制  Designed as per cGMP 设计符合 cGMP 要求

26 www.Biopharmax.com Stem cell processing facility 干细胞处理设施 Human Placenta source 人类胎盘源 EMEA Compliant 符合 EMEA 要求  1,400 SQM production site 1400 平方米生产现场  Upstream, downstream and filling 下游，上游和灌装  Clean utilities 洁净公用设施  Software as per CFR 21 part 11 软件按照 CFR 21 部分 11  Complete commissioning and validation 完整的试运行和验证  Laboratories and Offices 实验室和办公室

27 www.Biopharmax.com API manufacturing plant API 生产厂房 Tech –transfer and scale up 技术转移和扩大  Production suites for main products 主要产品生产套件  Clean rooms and HVAC 洁净室和 HVAC  Clean utilities 洁净公用设施  Plant utilities 厂房公用设施  Automation, control and programming 自动化，控制和编程  Full commissioning 完整试运行  FDA compliant 符合 FDA 要求

28 www.Biopharmax.com Sterile API fill and finish plant 无菌 API 灌装和成品厂房 Penem multi products 青霉烯多产品  Sterile bulk multi purpose production 多功能无菌原料产品  Final compounding and formulation 终混和配制  Powder filling in vials 西林瓶粉末灌装  Line manufacturer B+S B+S 的生产线  Packaging department 包装部门  FDA, EMEA compliant 符合 FDA ， EMEA 要求

29 www.Biopharmax.com Final formulation manufacturing plant Stouffville and hood road sites 最终制剂生产厂房  Purified water system 纯化水系统  Pretreatment, production, storage and distribution 预处理，生产，储存和分配  PC/PLC consolidated control system for all system/subsystems 所有系统 / 子系统的 PC/PLC 综合控制系统  Full commissioning and validation 完整试运行和验证  FDA compliant 符合 FDA 要求

30 www.Biopharmax.com Vilanterio plant  CAM increasing capacity: design, supply equipment piping instruments, equipment erection, piping installations, control works, validation CAM 容量扩展：设计，提供设备管道仪 器，设备安装，管道安装，控制工作， 验证  Modernization control of process: design, supply instruments control works, validation 工艺的现代化控制：设计，提供仪器控 制设备，验证 Bulciago plant  Replacement of 4 Glass lined reactors 15 CuM: dismount used reactors, erection of new reactors, piping installation, instrumentation and control 替换 4 个搪玻璃反应器 15CuM: 旧反 应器拆卸，新反应器安装管道安 装，仪表和控制 Settimo plant  Increasing production capacity: design, supply equipment, piping instruments, equipment erection, piping installation, control works, validation 扩大生产能力：设计，供应设备，管 道仪器，设备安装，管道安装，控制 工作，验证  Clean rooms for finishing department: design and construction 成品车间的洁净室：设计和建造

31 www.Biopharmax.com Prosintex Restoration and re-operation Chemical production line within 39 days 39 日内恢复重新运转化学生产线 After explosion 爆炸后

32 www.Biopharmax.com Prosintex Restoration and re-operation of chemical production line within 39 days 39 日内恢复重新运转化学生产线  Decontamination 消除污染  Civil construction work 土建工作  Equipment erection and replacement 设备安装和替代  Piping installation 管道安装  Control and programming 控制和编程  Full commissioning and validation 完整试运行和验证  FDA compliant 符合 FDA 要求

33 www.Biopharmax.com Biotechnology sterile production 生物技术无菌生产 Plant cells technology 植物细胞技术 EMEA Compliant 符合 EMEA 要求

34 www.Biopharmax.com  Production lines 生产线  Process equipment 工艺设备  Clean rooms 洁净室  Clean and general utilities 洁净和一般公用设施  Complete commissioning and validation 完整的试运行和验证

35 www.Biopharmax.com Biotechnology manufacturing and filling plant 生物技术生产和灌装厂房 Recombinant Hep-B 重组 Hep-B Mammalian Cell Technology 哺乳动物细胞技术

36 www.Biopharmax.com  Bioreactors suite 生物反应器套件  Filling suite for vials, packaging 小瓶灌装，包装套件  Clean utilities, WFI, PS 洁净公用设施， WFI,PS  Clean rooms ISO 5,8,9, HVAC 洁净室 ISO 5,8,9, HVAC  Laboratories, warehouse, offices, general areas 实验室，仓库，办公室，一般区  Automation and integration CFR 21 Part 11 自动化和一体化 CFR 21 部分 11  Commissioning and Validation 试运行和验证  EMEA compliant 符合 EMEA 要求

37 www.Biopharmax.com  Fully automated manufacturing facility 全自动化生产设施  Wet production block of 4 floor vertical flow 4 层垂直流湿生产模块  2 MPP 1 dedicated reaction lines 2 MPP 一条专用反应线  Automated batch processing 自动批处理  Dry processing – drying, milling, blending suites 干燥处理 - 干燥，磨粉，混合套件  Micronization suite 微粉化套件  Clean rooms, clean utilities, utilities 洁净室，洁净公用设施，公共设施  PC/PLC consolidated control system for all plant consumers 所有工厂使用者的 PC/ PLC 综合控制系统  Commissioning and validation 4 调试和验证 Multi purpose API manufacturing plant FDA compliant 多用途 API 生产厂房，符合 FDA 要求

38 www.Biopharmax.com Biotechnology R&D center Multi product pilot 生物技术研发中心 多种产品中试线 FDA, EMEA Compliant 符合 FDA 、 EMEA 要求  3,000 SQM area 3000 平米区域  Biotechnology laboratories 生物技术实验室  R&D laboratories 研发实验室  Chemical laboratories 化学实验室  Offices, storage, warehouse 办公区、储存区、仓库

39 www.Biopharmax.com API R&D center API 研发中心 Pilot scale production 中试规模生产  2200 SQM area 2200 平米区域  Clean rooms and HVAC 洁净室和 HVAC 系统  Analytical laboratories 分析实验室  Chemical laboratories 化学实验室  Pilot manufacturing unit 中试生产装置  HVAC and control HVAC 和控制系统  Offices 办公区 Teva tech

40 www.Biopharmax.com Microbiology Lab Renovation 微生物学实验室装修  250 sq.m. area 250 平方米  Classified Microbiology Labs 分级微生物实验室  General Laboratories 一般实验室  HVAC 暖通  Control and Software 控制和软件  Commissioning & Validation 试运行 & 验证

41 ON TIME! 按工期 ! ON BUDGET! 按预算 ! NO COMPROMISES ON RESULTS! 按质量 ! Build & Validate | Tailor Made | Biopharmaceutical Knowledge | Manufacturing Facilities & Systems

42 ON TIME! 按工期！ ON BUDGET! 按预算！ NO COMPROMISES ON RESULTS! 按质量！ Build & Validate | Tailor Made | Biopharmaceutical Knowledge | Manufacturing Facilities & Systems

43 Home Grown Technology 本土开发技术 Green Pretreatment for water systems 水系统绿色预处理  Electrolytically removing scale - pH precipitation 电解除水垢 —pH 沉淀  Destruction of chlorine - UV radiation 除氯 — 紫外线辐射 www.Biopharmax.com

44 Home Grown Technology 本土开发技术 Advantages 优点  No use of resins for softening 不使用树脂进行软化  No need for salt regeneration 无需盐再生  No generation of used salt brine 不会产生废盐水  No need for rinsing 无需漂洗  No chemicals needed for chlorine removal 不需使用化学品除氯  No active carbon with associated back wash 相应的反冲洗不使用活性炭  No moving parts 没有活动部件  Sanitization with hot water  Green Technology 绿色技术 www.Biopharmax.com Big water savings! 大量节约用水！