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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.

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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."— 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 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.

4 Sodium Hyaluronate (HA)
Produced by Genzyme’s 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. 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: Ophthalmology Soft tissue implants Wound healing Viscosupplementation of joints Bone regeneration Surface coatings Moisturizing agents Adhesion prevention Cell preservation Drug delivery Immunomodulation

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

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

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

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

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

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


15 A Single 16-Dimensional Point In Parallel Coordinates

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

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

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

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

20 Moving To Dynamic Approach… Best Operating Zone
Selecting Desired Results (X75) Reveals Pattern Of Behavior 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

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

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