Intelligent (Smart) Facility Mab Production Revolution

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1 Intelligent (Smart) Facility Mab Production Revolution Shanghai, June 13, 2017 Jing Zhou / Guangzhou Mab-Venture

2 Large vs. Small Time vs. Space Live vs. Dead JIT vs. Large Storage Topics to Explore Manual vs. Fully Automated Machine vs. People SS (Operation) vs Environmental Innovation vs. Operation New Industrial Revolution - Manufacturing 4.0 Biopharm Industrial Trends Challenging Lean Process PAT -Implementation of QbD SU & SS Smart/Intelligent Manufacturing Smart Integration of Hardware and Software

3 Be Competitive under the Bottom Line Earning = Revenue - Cost Quantities of Products or Services Under Quality control Unit Price by Product or Service R&D PD BD Quality System COGS Success Rate cgxp Control Environment/ Qualified People

4 Industry 4.0 From Smart Factory to Smart Production Internet Of Things Industry 4.0 Electronic IT Robotics Industry 3.0 C o m p l e x it y Steam Engine Widely Used Electric Power Industry Early 20 th Century Industry 1.0 Time

5 What is Smart Factory? A Smart Factory is a Manufacturing Solution That Provides such FLEXIBLE and ADAPTIVE production process that will solve problems arising on the production facility with dynamic and rapidly changing boundary conditions in the world of increasing complexity. This special solution could on one hand be related to automation, understood as a combination of software, hardware, and /or mechanics, which should lead to OPTIMIZATION of manufacturing resulting in reduction of unnecessary labor and waste of resource. On the other had, it could be seen in the perspective of COLLABORATION between different industrial and nonindustrial partners, where the smartness comes from forming a dynamic organization.

6 Benefits of Smart Factory By developing cyber physical system, and therefore their implementation in smart factories, significant improvements in production systems will be reflected in the form of Robustness at all levels: Self organized Self maintenance Self refurbishment Security Remote diagnosis Control in real time Autonomous management Transparency Predictability Effectiveness Efficiency

7 Automation Pyramid

8 Smart Factory Characters Smart Factory Equip needs to be Modularized and Smart: Modular System Structure to allow quick and flexible adaption to process/production requirements Expandability to allow insert the new Production Module through seamless integration Open Platform to allow universal connections for mechanical, Electrical, communication etc. to allow the compatibility of various vendors ; Smart parts, each components will have its own Identification number to be monitored through RFID technology Continuous Process & on-line Process Monitoring and control through PAT technology etc Optimization of Capital Investment & Operational Expense

9 Biopharm Manufacturing Trends Upstream Trend Expression Rate Enhancement Perfusion Process Fed-batch Operation Depth Filtration Adoption Downstream Trend Resin Binding Rate Increase Combo-Column to reduce the purification steps Semi-continued / continuous process In-line dilution process Fill & Finish Isolation Technology with C background Single Use/ Hybrid / SS Smart Factory

10 Manufacturing Steps Media Buffers Excipients Cell Culture Harvest/Purification Bulk Product (5-20 kg) Mixing Formulation Filling (Dosage Form) Packaging Saleable Product PRIMARY MANUFACTURE SECONDARY MANUFACTURE PACKAGING

11 Typical Mab BioProcess Steps UF/DF Fed-batch or Perfusion CEX PCC Nanofilt ration Clarification AIEX PCC Protein A Virus Inactivation

12

13 Degree of Exposure Closed Intermittent Exposure Exposed Levels of Biological Product Protection 3 Degree of Risk 2 1 Single Product Multi-Product Dedicated Equipment Multi-Product Multi-Use Equipment Facility Flexibility

14 Capital Investment vs. Operating Expense Year around Operation 常年运营 Single Product 单一产品 Larger Quantities 大批量 Hybrid 混合型 Operation by Campaigns 批次运营 Multiple Products 多品种 Smaller Quantities 小批量 Traditional 传统 Single Use 一次性使用

15 Flexibility/Adaptability/ Expandability Safety/Security Tracebility Constructability Chain Management / Communications Quality Intelligent (Smart) Factory Critical Construction Issues Finishes, Efficiency Finishing & Validation Planning & Control Risk Management Health & Safety Cost Control LEAN

16 Life Cycle Drug Development 4-10 YEARS 3-6 YEARS 9-12 YEARS RESEARCH DISCOVER Y & PATENT PRE CLINICAL TESTING Laboratory animals CLINICAL PHASE 1 Healthy volunteers CLINICAL PHASE 2 Patients (small group) CLINICAL PHASE 3 Patients (large group) PRODUCT LAUNCH REMAININ G PATENT PERIOD batches of material ranging from grams to tonnes Development Chemistry Laboratory Kilo Laboratory Pilot Plant Production

17 Lean Development for Capable Processes Preclinical Testing File IND at FDA Phase I Phase II Phase III File NDA at FDA FDA PRODUCTION PRODUCT A B C D E F G H Early Design for Manufacture process development gives fastest possible production of clinical trials material. Maximum Life Cycle Cost Savings Robust Designed for Manufacture process minimises scale up and gives fastest possible production start up.

18 URS Road Map for QbD implementation Development Implementation Product Development Process Development URS Facility Design IQ, OQ Quality Product Process Validation Regulations PAT Product Manufacturing

19 PAT Technology Utilization of process and unit operation modeling software packages Specification and implementation of proven on-line analyzers to replace outdated off-line methods Implementation of Statistical Process Control methods related to PLC and DCS systems Use of statistical analysis to pinpoint critical quality attributes Utilization of risk assessment methods to evaluate potential process changes Process improvement studies such as FMEA analysis of automated process systems

20 PAT 医药工业界 典范规则之转移 现有之典范规则 变量输入固定工艺变动的最终产品 未来 PAT 典范规则 变量输入 可调工艺 一致的最终产产品 将质量建立于工艺过程而非产品的质量检验!

21 PAT 完成 QbD 的工具 PAT - 强调对工艺了解的重要性 以助基于风险的审批决定和闯新 用合适的手段进行风险认知, 管理, 及控制 以工艺检测仪表现场测量及控制物质的物理与化学属性, 以达到现时报告的目的. 在产品周期内, 提高对该产品知识及其工艺开发知识的利用 一设计, 分析, 控制生产的体系. 该体系通过现场测量原材料, 生产中物料, 及其工艺流程的关键质量和性能, 而达到保证最终产品质量的目的.

22 CONTROLLED PROCESS Raw materials I n-process m aterial Environm ent Control Strategy Feed forw ard Feed back Process Param eters Real-t ime qualit y m easurem ent ( Real-t ime-release) Variable input Constant output Adaptable process End-product testing

23 ALIGNMENT OF PV APPROACH Product/Process Development Process Validation/PPQ Ongoing/Continued Process Verification Develop Control Strategy based on Product Quality Attributes Demonstrate effectiveness of control and establish variability in commercial manufacture Monitor process performance and variability during product life-cycle CRITICALITY X LIKELIHOOD X DETECTABILITY THESE ACTIVITIES CHARACTERISE RISK TO A PATIENT

24 Relationship Among QbD, ASTM, and PAT Final Product QbI Inspection/Outcome Trend Raw material Intermediates Final Product QbD Control/Process After Fact Just-in-time PAT Real time analysis GEP Root Cause Analysis SME ASTM 2500 Implementation

25 Product Life Cycle Quality & Risk Control Understanding Implementation Product Development Process Development Process Scale-up & Tech Transfer Manufacturing Product Knowledge Process Understanding Best Available Technology Implementation Risk Assessment Risk Assessment Risk Control Risk Control Product Design Space Process Design Space Product Quality Control Strategy Product Quality Control

26 ICH Q9 Quality Risk Management ICH Q9 质量风险管理 Initiate Quality Risk Management Process Formulation & Process design Risk Assessment Risk Identification Process understanding Risk Analysis Manufacturing Concept Process control Concept Ris k C ommun ic ation Risk Control Risk Evaluation Risk Reduction Risk Acceptance unacceptable R is k Manag ement tools Product release Concept Output / Result of the Quality Risk Management Process Regulatory strategy Risk Review Review Events Review the submission

27 The Quality Risk Mmanagement Process Five Steps: 1. Initiation 2. Risk Assessment Risk Identification Risk Analysis Risk Evaluation 3. Risk Control Risk Reduction Risk Acceptance 4. Output/Result 5. Risk Review Review Events Risk Assessment Fundamentals What could go wrong? What are the consequences (severity)? What is the likelihood (probability) it will go wrong?ay f ocus on th Questions: Is the risk above an acceptable level? What can be done to reduce or eliminate risk? If the risk were to be controlled, what is the appropriate balance among benefits, risk, and resources? Are new risk introduces as a identified risks being controlled?

28 Risk Control Activities for controlling risk (numbered by priority): Elimination by design Reduction to acceptable level Further risk analysis

29 Typical Control Hierarchy

30 Biopharmaceutical Manufacturing Automated Controls and Monitoring Systems Typical Scheme for Supporting GMP Unit Operations BMS Non-Validated BMS Validated HVAC Controls Validated EMS Validated Data Historian Validated Plant Utilities Alarms for: Boilers Chillers Waste Neut Electrical Gen Fire Protection Water Storage Utility Supply Natural Gas Electrical Water Process Utilities Alarms for: WFI/PW/PS CIP CDA Process Glycol Nitrogen Oxygen Cold Rooms Freezers Incubators HVAC AHU Blower And Damper Controls Cleanrooms Trending and alarms for: ΔP, T, %RH) Warehouse Raw Materials Finished Product Process Equipment Bioreactors Chromatography

31

32 Smart Integration Bottom up SmartMES Flexible, powerful MES Vision: Facility harmonization SmartSystems Universal or SmartSwitch Controllers SmartParts Intelligent Components

33 SmartParts Plug & Play True plug and play components Automation platform independence Distributed Control Enhanced performance (dynamic range, precision) Reduced cost Managed complexity SmartPump SmartMFC SmartTx

34 SmartSystems: Universal Controllers Universal Controller Concept Physical skid vs Controller Seamless Integration SmartSystems Enable Customer Choice One controller fits all Separate measurement / automation layer from physical skid Skid is defined by vendor Interface example: agitation, weight (load cells), TCU Enable user process using multiple vendor skids Facilitates scale-up/down and mix-and-match of skids Defined by automation USP available now; DSP available Seamless control of process skids from any vendor Finesse G3 Controller Family (Upstream) Development Pre-Clinical Clinical Trial Manufacturing Universal Controllers can adapt to ANY bioreactor from ANY vendor Configure to order G3Lab Universal R&D, small scale Configure to order G3Lite/G3 Pro Pilot through cgmp, large scale Engineer to order G3Flex Modular & Customizable cgmp, Any vessel type/size Full line of controllers for any vessel type or size designed for rapid scale-up and process transfer 21

35 Universal Controllers Universal controllers = flexible usage SmartGlass (1, 3, 7, 15L) SmartVessel (3,15L) SmartRocker (10, 20, 50L) G3Lab Universal Controller Single-Use Bioreactors (up to 250L with VAB) BioProcessing Flexibility Across Platforms & Brands

36 Universal Controllers Control any bioreactor in your process train 1 Thermo Fisher SUB/SUF 84% 2 ATMI 2% 2 Merck Millipore 7% 2 Universal Controller: L Xcellerex 6% 2 Sartorius 1% 2 Notes: 1) Not limited to current bioreactor generations; 2) Percent of 2016 cumulative bioreactor installations

37 SmartSystems: Universal Software Operator Station Universal Software Network for Upstream and Downstream Professional Plus Station Application Station and Historian OPC SERVER TruBio SCADA interface = control and monitor any OPC Compliant equipment Plant LAN DV Controller DeltaV Network OP C Finesse T300 Controller for Glass and SmartRocker Third Party Controllers: Sartorius/Applikon upstream or Palll/GE downstream TruBio native interface = control and monitor any Finesse or DeltaV equipment OP C Analyzers: Nova 100, 300, 400, BioProfile Flex Any OPC Compliant Instruments/Equip ment One common user interface with remote capability Unified process recipe + off-line analytics database A cost effective Control platform DeltaV Software and Network TruBio, TruPur and TruChrom Cost effective DeltaV licensing Both native DeltaV and SCADA versions Modbus comms standard (lowest DST) Fieldbus, Profibus or DeviceNet available TruBio/TruPur/TruChrom features Commercial Off The Shelf (COTS) Highly configurable and expandable Sophisticated control algorithms Parameter update in real-time Sensor redundancy and calibration 26

38 Downstream Harmonization Operator Station Professional Plus Station Application Station and Historian Phase 0: OPC connection Phase 1: SmartSwitch Phase 2: Universal Controllers Plant LAN DV Controller DeltaV Network (Dedicated, redundant process LAN) native native OPC native OPC native native native native native OPC OPC OPC OPC Buffer Prep Centrifugation Clarification Filtration Chromatography (Affinity/CEX/AEX) Ultra-filtration Virus Removal Sterile filtration

39 New Capabilities for the BPD Workflow Upstream Downstream Cell line development and media optimization Mixing, cell culture and fermentation Harvest and collection Purification Bulk storage and final fill Freedom CHO cell lines Process development and media optimization services Gibco cell culture media, feeds, and enhancers Single-use fermentors, bioreactors and mixers POROS harvest and separation products QC and analysis Storage and transport POROS chromatography resins CaptureSelect affinity ligands and resins Storage and transport BPCs, manifolds and containers Shaker flasks and rigid containment BioProcess containers Mycoplasma and viral detection Transfer assemblies Acclimate single-use frozen handling system Production chemicals Sensors insite Integrity Testing System Cell factories GMP warehousing, sampling and lot control Host cell DNA, protein and protein A quantitation Large volume liquids Pump Tower Skids Sensors Software Lab-scale Bioreactors Lab-scale Controllers Software (TruBio) Large volume liquids Sensors Controllers US Controllers/Skids Software (TruPur) DS Controllers/Skids Software (TruChrom) Software (TruBio) SmartFactory Legend Grey text: Legacy BPD capabilities Red text: Finesse expanded capabilities

40 Our Platform cgmp SmartFactory GMP Facility Our under-construction SMART cgmp manufacturing facility at Guangzhou Bio Island, generates Mab materials for clinical trials & commercial launch. Multiple Product Lines Facility for Future Maximum Flexibility, Adaptability, and Expandability Global Compliance

41 Summary Fit for purpose In Line With Corporate Strategy Continuous/Lean Process Smart Facility/ Smart Modulars/ Smart Parts Smart Team/ Smart People Smart System Compliant With Regulations Smart Execution Smart Operation is the Competitive Advantages

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