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IDA Ireland / PharmaChemical Ireland Symposium The Road to Integrated Development and Manufacturing Jacintha Griffin Wyeth Newbridge September 23 rd 2009. Overview. The Road to Integrated Development & Manufacturing From technical transfer to Co-development - PowerPoint PPT Presentation

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  • IDA Ireland / PharmaChemical Ireland Symposium

    The Road to Integrated Development and Manufacturing

    Jacintha GriffinWyeth Newbridge

    September 23rd 2009

  • Overview The Road to Integrated Development & Manufacturing

    From technical transfer to Co-development

    Pharmaceutical Development Centre (PDC) business case

    PDC Newbridge Capability, facility and approach to integrated development & manufacturing

    Development and Manufacturing Model - Future Opportunities and Challenges

  • Wyeth Newbridge The Road to Integrated Development & Manufacturing1992 - 200320042005200720082009Technical Transfers & Process OptimisationCo-Development & Clinical Trial SuppliesPDC Concept ApprovalNew products organization & PDCs in OperationNewbridge PDC Construction StartNewbridge PDC Opens

  • Pharmaceutical Development Centre (PDC) Integrated Development and ManufacturingBusiness Case and Fiscal SupportsCritical Supports in Justifying Business Case for Development centre:

    Proven technical capability of supporting a large portfolio of solid dosage products

    Demonstrated capability in collaborating with corporate R&D - Co-development

    Collaboration with the IMB for rapid application, audit and receipt of IMP licence

    Process optimization for marketed product portfolio - Quality by re-Design

    Changing regulatory environment impact of ICH Q8, 9, 10

    Government, IDA mandate and supportR&D Tax Credit System & capability grants12.5% Corporation TaxIP Royalty Scheme

  • PDC Charter and value proposition

  • PDC NewbridgeMulti-Purpose Multi- Product cGMP Module

    Pilot Scale 5-50kg 1/10th the commercial scale of pipeline products

    Small Scale (

  • Molecular

    Particulate

    Bulk powder

    Final dosage form

    Spectroscopic: NIROther chemical: Analysis to support physical characterisation (GQAD)Crystallographic: X-Ray Powder Diffraction (with Controlled Humidity Chamber)Microscopic: Scanning Electron Microscopy, Optical Microscopy, Image AnalysisThermal: Differential Scanning Calorimetry, Thermogravimetric AnalysisMicromeritic: Specific Surface Area, Dynamic Vapour Sorption, Particle Size AnalysisMechanical: Texture AnalysisFlow: Powder RheometryAgglomeration: Air Jet SievingMoisture: Loss on Drying, Water ActivityDensity: Bulk and Tapped Density, Helium Pycnometry, Envelope DensityCoating Layer Thickness: Terahertz Pulsed ImagingTablet Dimensions: Tablet AutotesterFocus on Capability Process Characterisation

  • PAT & Data Management Infrastructure 1 5kg & 5 50kg EquipmentProcess Char. LabLIMSSAP ERPBMSPAT Tools

  • Newbridge PDC CompetenciesCross Functional Team with Qualifications, Subject Matter Expertise and Practical Experience in:Material SciencePowder Properties, Spectroscopic TechniquesFormulation DesignPharmaceutics, Drug development, PharmacokineticsProcess Design & Process EngineeringProcess developmentAnalytical Method Design and Development Spectroscopic Techniques, QbD for methodsScale-up Expertise, Operational excellence and Lean manufacturing methodologiesProcess Analytical Technology and Chemometrics expertiseIT, Automation and Data ManagementSoftware Programming, Automation and Control SystemsQuality and ComplianceRegulatory understanding and application of CFR, GMP and ICH Q8, Q9 and Q10

  • Organisational structure to deliver successNew Products and Process Development (NPPD) Accountable for all new product activities from Proof of Concept (PoC)

    Key operating principles:Quality by Design and Quality Risk Management principles embedded

    API and Drug product accountabilities

    Broad scope clinical relevance and manufacturing optimization

    Smart Development - Do more with less API using QbD and DoEs

    Drive Finished Product dosage to support standardized technology platforms

    PDC network part of NPPD

  • CorporateR&D PipelinePipelinePuerto RicoPDC

    Newbridge PDCProcess Knowledge 3rd Party

    Puerto RicoNewbridge, IrelandNew Products & Process Development (NPPD) and PDC Network

  • Building blocks for integrated Development & ManufacturingUsing Quality Risk Management techniques to drive the level of development activities required to yield the highest level of scientific knowledge

    Understand inputs - physical characterisation techniques

    Structured development programme - Understand Design space and interdependencies through DOEs

    Data management infrastructure - design allows for the ability to Acquire, Analyse, Archive and Report Product and Process Data

    Advanced chemometrics and statistical modelling to interrogate and understand data

    Process Analytical Technology (PAT) for real time monitoring, prediction and control of quality attributes

    Elimination of science of scale through knowledge management, model creation & Management

    Regulatory filing (Design & Control space) and elimination of post approval changes

  • PDC Co-location with ManufacturingA Win - Win

    Development co-located with manufacturing at commercial site -

    Enhanced technical expertise to support both marketed and pipeline portfolios

    Seamless knowledge transfer from late stage development through to commercial

    Manufacturing requirements and input earlier into development programme

    Influences standardized technology platform selection

    Technical training and site upskilling

    Reduction in regulatory complexity Learn before filing

    Deployment of PAT with a purpose Pull not Push

  • Looking to the futureFuture OpportunitiesLeverage from Competence Centres/Clusters Solid state Pharmaceutical cluster (SSPC) etc

    Build RD&I reputation IP, publications, conferences

    Business Process Innovation

    RTR & Continuous Manufacturing

    Industry ChallengesAvailability of personnel with cross functional skills

    Alignment and harmonisation of regulatory requirements of EMEA / Japan / FDA & other global markets

  • Summary

    Build on manufacturing expertise and proven track recordTech, transfers, scale up, operational excellence

    Build and deliver on business caseDrive an integrated & innovative approach to development and manufacturingFocus on smart development and manufacturing excellenceScience driving complianceSimple PAT solutions

    Grow a highly skilled, cross functional TeamDiverse backgrounds formulation & process development, automation, statistics, chemometrics, analytics & engineering

    Overall result: Enhanced process knowledge -Defined targets & ranges for CPP and CQA Enhanced robustness, reduced COGs, elimination of scale up issues

  • Thank You

    Questions?