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Heads Up Analysis Vs High Dimensionality Problems: Using Data Visualization as an Analytical Tool In Advanced Solutions Applied to Manufacturing Data Gloria.

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Presentation on theme: "Heads Up Analysis Vs High Dimensionality Problems: Using Data Visualization as an Analytical Tool In Advanced Solutions Applied to Manufacturing Data Gloria."— Presentation transcript:

1 Heads Up Analysis Vs High Dimensionality Problems: Using Data Visualization as an Analytical Tool In Advanced Solutions Applied to Manufacturing Data Gloria Gadea-Lopez, Ph.D., Genzyme Corporation Robert H. McCafferty, Curvaceous Software International Forum for Process Analytical Chemistry January 15, 2004

2 IFPAC 2004 Application of Parallel Cordinates as Data Mining Tool at Genzyme Gloria Gadea-Lopez, Ph.D.

3 Introduction Genzyme Corporation is the leading manufacturer of sterile Sodium Hyaluronate Genzyme Corporation is the leading manufacturer of sterile Sodium Hyaluronate Unique viscoelastic properties that make it the ingredient of choice for ophtalmic applications and post-surgery antiadhesion products Unique viscoelastic properties that make it the ingredient of choice for ophtalmic applications and post-surgery antiadhesion products Produced under a proprietary Genzyme fermentation and purification method that yields highly purified, exceptional quality material. Produced under a proprietary Genzyme fermentation and purification method that yields highly purified, exceptional quality material.

4 Sodium Hyaluronate (HA) Produced by Genzymes Advanced Biomaterials since 1984 Produced by Genzymes Advanced Biomaterials since 1984 In its natural form, HA typically exists as a sodium salt (sodium hyaluronate), which can form a highly viscous fluid (viscoelastic) with exceptional lubricating qualities. In 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. 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 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.Seprafilm® Genzyme's HA is also being used in commercially available ophthalmic products. Genzyme's HA is also being used in commercially available ophthalmic products. Established and potential applications for HA include: Established and potential applications for HA include: Ophthalmology Ophthalmology Soft tissue implants Soft tissue implants Wound healing Wound healing Viscosupplementation of joints Viscosupplementation of joints Bone regeneration Bone regeneration Surface coatings Surface coatings Moisturizing agents Moisturizing agents Adhesion prevention Adhesion prevention Cell preservation Cell preservation Drug delivery Drug delivery Immunomodulation Immunomodulation

6 Making More and Better HA Process with a lot of history Process with a lot of history Existing legacy of previous facility Existing legacy of previous facility Lessons to be applied to new expanded facility Lessons to be applied to new expanded facility Exercise with Curvaceous Software Exercise with Curvaceous Software Data from 150 batches, 70 variables Data from 150 batches, 70 variables Raw material lot informationRaw material lot information Process conditions for each unit operationProcess conditions for each unit operation Cycle times per batchCycle times per batch Properties of the final product (Quality Control data for release).Properties of the final product (Quality Control data for release).

7 Using Parallel Coordinates - Objectives Discover hidden relationship among process variables that lead to Discover hidden relationship among process variables that lead to Higher yield Higher yield Viscoelastic properties in optimum range Viscoelastic properties in optimum range Prevent process conditions in ranges that lead to adverse results Prevent process conditions in ranges that lead to adverse results Optimize raw material properties Optimize raw material properties Work with suppliers to ensure consistent properties of key raw materials. Work with suppliers to ensure consistent properties of key raw materials.

8 Collecting the Data Information from diverse sources Information from diverse sources Batch records Batch records Raw material information Raw material information Final QC (Certificate of Analysis) Final QC (Certificate of Analysis) Process history resides in MERLIN, Genzymes custom process database. Process history resides in MERLIN, Genzymes custom process database.

9 Biotech Processes are not Flat File Friendly In-Process DataRaw Materials LOT101 Lot Pooling Final Product QC Data Fill/Finish LOT201 LOT202 Purification LOT301 LOT302 LOT303 Lot Splitting Recovery LOT401 LOT402 LOT403 BioReactor Effects on Final Product Quality? Purification

10 Typical Data Analysis Using ODBC, link Merlin and JMP (SAS), Excel, Chart FX, QC Charter Using ODBC, link Merlin and JMP (SAS), Excel, Chart FX, QC Charter Linear regression models Linear regression models Process Capability Process Capability Multivariate with some key properties Multivariate with some key properties Control Charts (Shewhart) Control Charts (Shewhart) Need comprehensive analysis. We know there is more…… 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 Practice Typical Industry Practice Few High Return Processes Fully Understood Few High Return Processes Fully Understood Complex Chain/Hierarchy Of Intricate Unit Processes Complex Chain/Hierarchy Of Intricate Unit Processes Brute Force Numerical Analysis Characterization Method Of Choice Brute Force Numerical Analysis Characterization Method Of Choice Human Intelligence Relegated To Back Seat Human Intelligence Relegated To Back Seat Jungle Of N-Space Impenetrable Jungle Of N-Space Impenetrable New Process Knowledge Latent In Existing Data New Process Knowledge Latent In Existing Data Key To Extraction Engaging Human Mind… Native Curiosity Key To Extraction Engaging Human Mind… Native Curiosity Eyes Primary Path Of Information Input To Human Brain Eyes Primary Path Of Information Input To Human Brain N-Dimensional Visualization Breakthrough Technology N-Dimensional Visualization Breakthrough Technology 3-Dimensional Status Quo Must Be Broken 3-Dimensional Status Quo Must Be Broken

13 Parallel Coordinates Substantial Foundation In N-Dimensional Geometry Substantial Foundation In N-Dimensional Geometry Map N-D Into 2-D Through Coordinate Transform Map N-D Into 2-D Through Coordinate Transform Allow Direct Data Visualization And Manipulation Allow Direct Data Visualization And Manipulation Many Process Variables Simultaneously (30+) Many Process Variables Simultaneously (30+) Mathematically Robust… Zero Information Loss Mathematically Robust… Zero Information Loss No Derived Quantities (Re, Nu, PC, etc.) Required No Derived Quantities (Re, Nu, PC, etc.) Required True Visualization True Visualization Otherwise Unobservable Phenomena Easily Seen Otherwise Unobservable Phenomena Easily Seen Readily Explained Readily Explained

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15 A Single 16-Dimensional Point In Parallel Coordinates

16 Visual Analysis Patterns Formed When Many Points Plotted Patterns Formed When Many Points Plotted Human Brain Superlative Pattern Recognizer Human Brain Superlative Pattern Recognizer Very Good At Seeing The Big Picture Very Good At Seeing The Big Picture Eyes Better Than Algorithms Eyes Better Than Algorithms No Absolute Requirement To Understand No Absolute Requirement To Understand Process Physics Process Physics Mathematics Mathematics Statistics Statistics Process Knowledge Real Key Process Knowledge Real Key Anyone Can Contribute Anyone Can Contribute

17 Applying Good, Better, Best Criteria Uncovers Patterns Sweet Spots - Concentrations Of Yellow - Appearing Sweet Spots - Concentrations Of Yellow - Appearing High X14 (Biosynthesis End Criteria) Clearly Best For Product High X14 (Biosynthesis End Criteria) Clearly Best For Product Nearly All Premium Production From One X3 Level… High X5 Best Nearly All Premium Production From One X3 Level… High X5 Best

18 Delving Into More Variables... Curious Hole In Two Process Variables Curious Hole In Two Process Variables Obvious Bad Range - Poison Zone - For Another Obvious Bad Range - Poison Zone - For Another Clear Relationship Between Two Others, High Values Favored Clear Relationship Between Two Others, High Values Favored

19 Looking At Final Process Results Different Modes Of Process Operation Plainly Visible Different Modes Of Process Operation Plainly Visible Clear Sweet Spot Relationships For Key Time Variables Clear Sweet Spot Relationships For Key Time Variables Fair Correlation Between Lab Measurement & Final Rheology Fair Correlation Between Lab Measurement & Final Rheology

20 Moving To Dynamic Approach… Best Operating Zone Selecting Desired Results (X75) Reveals Pattern Of Behavior Selecting Desired Results (X75) Reveals Pattern Of Behavior Pattern Inherently Incorporates Process Variable Interactions Pattern Inherently Incorporates Process Variable Interactions

21 Process Camera Pattern Of Process Variable Interactions (Red Lines) Used To Derive Working Limits (Green Lines)… Exploited For Control Pattern Of Process Variable Interactions (Red Lines) Used To Derive Working Limits (Green Lines)… Exploited For Control

22 Genzyme Lessons Leverage Standing IT Investment Leverage Standing IT Investment Databases Databases Network Infrastructure Network Infrastructure Harvest New Knowledge From Existing Data Harvest New Knowledge From Existing Data Engage Complementary Visualization Technology Engage Complementary Visualization Technology Analyze Full Span Of Process Data Available Analyze Full Span Of Process Data Available Capitalize On Engineering Knowledge Capitalize On Engineering Knowledge Effectively Mine Existing Records Effectively Mine Existing Records Exploit Gains Exploit Gains Problem Resolution Problem Resolution Response Surface Visualization Response Surface Visualization Process Optimization Process Optimization Dynamic Control Dynamic Control


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