Presentation on theme: "Heads Up Analysis Vs High Dimensionality Problems: Using Data Visualization as an Analytical Tool In Advanced Solutions Applied to Manufacturing Data."— Presentation transcript:
1 Heads Up Analysis Vs High Dimensionality Problems: Using Data Visualization as an Analytical Tool In Advanced Solutions Applied toManufacturing DataGloria Gadea-Lopez, Ph.D., Genzyme CorporationRobert H. McCafferty, Curvaceous SoftwareInternational Forum for Process Analytical ChemistryJanuary 15, 2004
2 IFPAC 2004Application of Parallel Cordinates as Data Mining Tool at GenzymeGloria Gadea-Lopez, Ph.D.
3 IntroductionGenzyme Corporation is the leading manufacturer of sterile Sodium HyaluronateUnique viscoelastic properties that make it the ingredient of choice for ophtalmic applications and post-surgery antiadhesion productsProduced under a proprietary Genzyme fermentation and purification method that yields highly purified, exceptional quality material.
4 Sodium Hyaluronate (HA) Produced by Genzyme’s Advanced Biomaterials since 1984In its natural form, HA typically exists as a sodium salt (sodium hyaluronate), which can form a highly viscous fluid (viscoelastic) with exceptional lubricating qualities.Plays an important role in a number of physiological functions including, cells protection and lubrication, maintenance of the structural integrity of tissues, transport of molecules, and fluid retention and regulation.
5 Sodium Hyaluronate - Applications Genzyme's Seprafilm®, which is used during surgery as an adjunct intended to reduce the incidence, extent, and severity of post-surgical adhesion formation in the abdominopelvic cavity.Genzyme's HA is also being used in commercially available ophthalmic products.Established and potential applications for HA include:OphthalmologySoft tissue implantsWound healingViscosupplementation of jointsBone regenerationSurface coatingsMoisturizing agentsAdhesion preventionCell preservationDrug deliveryImmunomodulation
6 Making More and Better HA Process with a lot of historyExisting legacy of previous facilityLessons to be applied to new expanded facilityExercise with Curvaceous SoftwareData from 150 batches, 70 variablesRaw material lot informationProcess conditions for each unit operationCycle times per batchProperties of the final product (Quality Control data for release).
7 Using Parallel Coordinates - Objectives Discover “hidden” relationship among process variables that lead toHigher yieldViscoelastic properties in optimum rangePrevent process conditions in ranges that lead to adverse resultsOptimize raw material propertiesWork with suppliers to ensure consistent properties of key raw materials.
8 Collecting the Data Information from diverse sources Batch recordsRaw material informationFinal QC (Certificate of Analysis)Process history resides in MERLIN, Genzyme’s custom process database.
9 Biotech Processes are not “Flat File” Friendly LOT101Lot PoolingFinal Product QC DataFill/FinishPurificationLOT201LOT202PurificationLOT301LOT302LOT303Lot SplittingRecoveryLOT401LOT402LOT403BioReactorEffects on Final Product Quality?In-Process DataRaw Materials
10 Typical Data AnalysisUsing ODBC, link Merlin and JMP (SAS), Excel, Chart FX, QC CharterLinear regression modelsProcess CapabilityMultivariate with some key propertiesControl Charts (Shewhart)Need comprehensive analysis. We know there is more……
11 What N-Space Really Looks Like… And How To Make It Pay In Spades Robert H. McCafferty, Curvaceous Software Limited
12 Beyond The Third Dimension Typical Industry PracticeFew High Return Processes Fully UnderstoodComplex Chain/Hierarchy Of Intricate Unit ProcessesBrute Force Numerical Analysis Characterization Method Of ChoiceHuman Intelligence Relegated To Back SeatJungle Of N-Space ImpenetrableNew Process Knowledge Latent In Existing DataKey To Extraction Engaging Human Mind… Native CuriosityEyes Primary Path Of Information Input To Human BrainN-Dimensional Visualization Breakthrough Technology3-Dimensional Status Quo Must Be Broken
13 Parallel Coordinates Substantial Foundation In N-Dimensional Geometry Map N-D Into 2-D Through Coordinate TransformAllow Direct Data Visualization And ManipulationMany Process Variables Simultaneously (30+)Mathematically Robust… Zero Information LossNo Derived Quantities (Re, Nu, PC, etc.) RequiredTrue VisualizationOtherwise Unobservable Phenomena Easily SeenReadily Explained
15 A Single 16-Dimensional Point In Parallel Coordinates
16 Visual Analysis Patterns Formed When Many Points Plotted Human Brain Superlative Pattern RecognizerVery Good At Seeing The Big PictureEyes Better Than AlgorithmsNo Absolute Requirement To UnderstandProcess PhysicsMathematicsStatisticsProcess Knowledge Real KeyAnyone Can Contribute
17 Applying Good, Better, Best Criteria Uncovers Patterns Sweet Spots - Concentrations Of Yellow - AppearingHigh X14 (Biosynthesis End Criteria) Clearly Best For ProductNearly All Premium Production From One X3 Level… High X5 Best
18 Delving Into More Variables... Curious “Hole” In Two Process VariablesObvious Bad Range - Poison Zone - For AnotherClear Relationship Between Two Others, High Values Favored
19 Looking At Final Process Results Different Modes Of Process Operation Plainly VisibleClear Sweet Spot Relationships For Key Time VariablesFair Correlation Between Lab Measurement & Final Rheology
20 Moving To Dynamic Approach… Best Operating Zone Selecting Desired Results (X75) Reveals Pattern Of BehaviorPattern Inherently Incorporates Process Variable Interactions
21 Process CameraPattern Of Process Variable Interactions (Red Lines) Used To Derive Working Limits (Green Lines)… Exploited For Control
22 Genzyme Lessons Leverage Standing IT Investment DatabasesNetwork InfrastructureHarvest New Knowledge From Existing DataEngage Complementary Visualization TechnologyAnalyze Full Span Of Process Data AvailableCapitalize On Engineering KnowledgeEffectively Mine Existing RecordsExploit GainsProblem ResolutionResponse Surface VisualizationProcess OptimizationDynamic Control