Process Definition Management: Using ISA-88 and BatchML as a basis for Process Definitions and Recipe Normalization Paul W...
Business Imperative: Top Three Life Science Innovation Goals for 2012  <ul><li>Leverage scientific/ technological advances...
Product Life Cycle Process Definition Pilot Scale Early Development Late Development Project Management LIMS / SDMS QMS / ...
Business Processes Impacting Time-to-Market: Early Stage Product and Process Innovation  Knowledge of  Future   Manufactur...
Business Processes Impacting Time-to-Market:  Late Stage Process Development  through Ramp to Commercial Manufacturing Fou...
“ Master Data”:  Coordination Points for Manufacturing include both Product and Process  Opportunity to use  ISA-88 recipe...
ISA-88 Operations Ice Cream Recipe Example The Blend Ingredients Operation  -  eight phases associated with blending ingre...
A Solution for Faster Time to Market <ul><li>Process Definition Management </li></ul><ul><ul><li>Define all recipes in a c...
Key Use Cases in  Process Definition Management  <ul><li>Create Reusable Manufacturing Actions (RMAs) </li></ul><ul><li>Au...
Create Reusable Manufacturing Actions <ul><li>Challenges: </li></ul><ul><ul><li>Process Definition Management requires reu...
Author Process Definitions (“Recipes”) <ul><li>Challenges: </li></ul><ul><ul><li>No practice for representing process defi...
Document Process Parameters <ul><li>Challenges: </li></ul><ul><ul><li>Parameters authored separately from process flows  <...
Technology Transfer <ul><li>Challenges: </li></ul><ul><ul><li>Process definitions are represented in human-readable docume...
Process Knowledge Management <ul><li>Challenges: </li></ul><ul><ul><li>Document-based approaches to recipe representation ...
What is the Recipe for  Addressing these Issues? <ul><li>Create a purpose-built process definition editor  </li></ul><ul><...
Solution:  Process Definition Editor <ul><li>ANSI/ISA 88 for standard look and feel for the “flowchart” user experience </...
What is ISA-88 (“S88”)? <ul><li>Standard for: </li></ul><ul><ul><li>Graphical representation of batch manufacturing proces...
What is BatchML? <ul><li>Standard maintained by the World Batch Forum for XML representation of data for all three ISA-88 ...
The Process Definition Editor BatchML storage of recipes and recipe building blocks ISA-88 Editor for visual editing and n...
Product Life Cycle Process Definition Pilot Scale Early Development Late Development Project Management LIMS / SDMS QMS / ...
Proce s s Definition Editor <ul><li>Key Benefits </li></ul><ul><li>More rapidly create, edit, visualize, reuse data in rec...
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Process Definition Management using ISA-88 and BatchML

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  • Process Definition Management using ISA-88 and BatchML

    1. 1. Process Definition Management: Using ISA-88 and BatchML as a basis for Process Definitions and Recipe Normalization Paul Wlodarczyk and Mike Power WBF European Conference 11-13 November 2008
    2. 2. Business Imperative: Top Three Life Science Innovation Goals for 2012 <ul><li>Leverage scientific/ technological advances to assure superior therapeutic outcomes in their target patient population. </li></ul><ul><li>Improve acquisitions/ alliance / licensing management processes to improve agility in bringing new products to market. </li></ul><ul><li>Decrease the concept-to-patient lifecycle from the current 7-11 years to 5-7 years </li></ul>Survey respondents estimated 19% growth in spending on technology to support R&D in 2012; this is slightly higher among branded and generics with estimated growth of 23%. Mid-market Life Sciences companies also plan for more aggressive growth than their larger counterparts, they plan to increase their spending by nearly 30%. Source: AMR Research 2007 Life Sciences Survey Product Demand Supply
    3. 3. Product Life Cycle Process Definition Pilot Scale Early Development Late Development Project Management LIMS / SDMS QMS / CAPA Lab Scale Electronic Lab Notebooks Users Project Operations Scientists Chemists Biologists Pharmacists Engineers Technicians Operators Support Analytical Quality MES ERP PLM Development Management Tech Transfer Clinical I Clinical II Clinical III Commercial Experiments Process Unit Procedures Commercial Scale Source: Mike Power, BearingPoint Product Demand Supply
    4. 4. Business Processes Impacting Time-to-Market: Early Stage Product and Process Innovation Knowledge of Future Manufacturing Environment <ul><li>Result = foundation of process knowledge </li></ul><ul><li>Goal = predict manufacturing performance under commercial operating conditions </li></ul>Manage Process Knowledge Creation Knowledge of Chemistry, Microbiology, Physics <ul><li>Process </li></ul><ul><li>Requirements </li></ul><ul><li>Meets cGMP? </li></ul><ul><li>Safe? </li></ul><ul><li>Commercially </li></ul><ul><li>viable? </li></ul>common information models Manage Process Knowledge Discovery Early Stage Product and Process Development: Lab to Bench Scale Pilot Source: Alison Smith, AMR Research Rapid Iterations Product Demand Supply
    5. 5. Business Processes Impacting Time-to-Market: Late Stage Process Development through Ramp to Commercial Manufacturing Foundation of preliminary process knowledge Experience in Existing Manufacturing Environment <ul><li>Process Improvements </li></ul><ul><li>Improves yield? </li></ul><ul><li>Reduces variability? </li></ul><ul><li>Commercially </li></ul><ul><li>viable? </li></ul>Pilot to Scale Up for Commercial Production Continuous Improvements / Refinements within Design Space 12 – 36 mos. common information models Manage Process Knowledge Sharing Manage Process Knowledge Retention Manage Applying Process Knowledge Opportunity! Source: Alison Smith, AMR Research Product Demand Supply
    6. 6. “ Master Data”: Coordination Points for Manufacturing include both Product and Process Opportunity to use ISA-88 recipe as the common information model for process definitions? Supply Demand Product Design/Formulation Marketing Collateral Service Docs Data Sync E-Commerce Order Acquisition & Management Supply Chain Planning (mBOM, Routing) Sourcing & Procurement Product Package Design/ Label Claims Recipe Management Detailed Routing Bill of Equipment Bill of Process Bill of Compliance/ CoA Bill of Test Asset Maintenance Bill of Materials Process Specifications Process Engineering Maintenance Plans SOPs Asset Performance Management Opportunity to use ISA-88 recipe as the common information model for process definitions? Opportunity to use ISA-88 recipe as the common information model for process definitions? common information models
    7. 7. ISA-88 Operations Ice Cream Recipe Example The Blend Ingredients Operation - eight phases associated with blending ingredients. Note there is no rule on running only one phase at a time. In fact, it is very common for multiple phases to be running simultaneously. Recipe represented in an industry standard ISA-88 SFC (sequential function chart)
    8. 8. A Solution for Faster Time to Market <ul><li>Process Definition Management </li></ul><ul><ul><li>Define all recipes in a common information model </li></ul></ul><ul><ul><li>Build a library of Reusable Manufacturing Actions </li></ul></ul><ul><ul><li>Assemble new Recipes from components in library </li></ul></ul><ul><li>Benefits: </li></ul><ul><ul><li>Standardize on Good Manufacturing Practices </li></ul></ul><ul><ul><li>Feedback loop from Manufacturing to Development </li></ul></ul><ul><ul><li>Improved technology transfer </li></ul></ul><ul><ul><li>Process Knowledge Management </li></ul></ul><ul><ul><li>Bottom line: Quality by Design, Faster time to market </li></ul></ul>Development Process Library Execution Systems Operator Instructions Submission Ready Components Contract Manufacturing Structured Data Sources Common Steps & Actions Common Steps & Actions Commercial Process Library
    9. 9. Key Use Cases in Process Definition Management <ul><li>Create Reusable Manufacturing Actions (RMAs) </li></ul><ul><li>Author Process Definitions (“Recipes”) </li></ul><ul><li>Document Process Parameters </li></ul><ul><li>Transfer Technology </li></ul><ul><li>Manage Knowledge </li></ul>Create Reusable Manufacturing Actions Author Process Definitions Document Process Parameters Transfer Technology Manage Knowledge
    10. 10. Create Reusable Manufacturing Actions <ul><li>Challenges: </li></ul><ul><ul><li>Process Definition Management requires reuse of codified content (RMAs or recipe building blocks) </li></ul></ul><ul><ul><li>No best practice for representing recipes and RMAs outside of manufacturing </li></ul></ul><ul><ul><li>No method for implementing reuse </li></ul></ul><ul><li>Impacts: </li></ul><ul><ul><li>Benefits of recipe normalization are not achieved during Discovery and Clinical phases of lifecycle – time and money left on the table </li></ul></ul>Create Reusable Manufacturing Actions Author Process Definitions Document Process Parameters Transfer Technology Manage Knowledge
    11. 11. Author Process Definitions (“Recipes”) <ul><li>Challenges: </li></ul><ul><ul><li>No practice for representing process definitions outside of Batch Control (where ISA-88 is the standard) </li></ul></ul><ul><ul><li>No “purpose-built” tools – just spreadsheets and flowcharts </li></ul></ul><ul><ul><li>Automation requires custom development </li></ul></ul><ul><ul><li>Parameters and flows managed as large documents </li></ul></ul><ul><li>Impacts : </li></ul><ul><ul><li>Low authoring productivity. Authoring recipes takes months. </li></ul></ul><ul><ul><li>Difficult to track changes at an elemental level. No audit trail </li></ul></ul><ul><ul><li>Automation requires software development and maintenance </li></ul></ul>Create Reusable Manufacturing Actions Author Process Definitions Document Process Parameters Transfer Technology Manage Knowledge
    12. 12. Document Process Parameters <ul><li>Challenges: </li></ul><ul><ul><li>Parameters authored separately from process flows </li></ul></ul><ul><ul><li>Spreadsheets are the current best practice – but are 1000s of rows long </li></ul></ul><ul><ul><li>No way to link to or standardize “Bills of X” </li></ul></ul><ul><ul><li>No established best practice for regulatory reporting of CTQ / KTQs </li></ul></ul><ul><li>Impacts: </li></ul><ul><ul><li>Low authoring productivity, no way to track/maintain parameters </li></ul></ul><ul><ul><li>No element-level change management or audit trail </li></ul></ul><ul><ul><li>Disconnected from systems of record </li></ul></ul><ul><ul><li>Difficulty supporting Quality by Design </li></ul></ul>Create Reusable Manufacturing Actions Author Process Definitions Document Process Parameters Transfer Technology Manage Knowledge
    13. 13. Technology Transfer <ul><li>Challenges: </li></ul><ul><ul><li>Process definitions are represented in human-readable documents, not available as data </li></ul></ul><ul><ul><li>Recipes need to be manually entered into Batch Control and execution systems </li></ul></ul><ul><li>Impact: </li></ul><ul><ul><li>Ineffective and inefficient technology transfer </li></ul></ul><ul><ul><ul><li>Quality </li></ul></ul></ul><ul><ul><ul><li>Yield </li></ul></ul></ul><ul><ul><ul><li>Cycle time </li></ul></ul></ul>Create Reusable Manufacturing Actions Author Process Definitions Document Process Parameters Transfer Technology Manage Knowledge
    14. 14. Process Knowledge Management <ul><li>Challenges: </li></ul><ul><ul><li>Document-based approaches to recipe representation </li></ul></ul><ul><ul><li>Discovery requires full-text keyword search </li></ul></ul><ul><li>Impacts: </li></ul><ul><ul><li>Barriers to information discovery and knowledge sharing </li></ul></ul><ul><ul><li>Sharing of Good Manufacturing Practices is manual, uneven – lost productivity, gains are not repeatable </li></ul></ul><ul><ul><li>No common method of representing “manufacturing process IP” </li></ul></ul><ul><ul><li>No mechanism for IP management </li></ul></ul>Create Reusable Manufacturing Actions Author Process Definitions Document Process Parameters Transfer Technology Manage Knowledge
    15. 15. What is the Recipe for Addressing these Issues? <ul><li>Create a purpose-built process definition editor </li></ul><ul><li>Make documents “componentized” </li></ul><ul><li>Enable valuable content to be extracted and reused from recipes (for knowledge management, RMA, etc.) </li></ul><ul><li>Use SFC flowcharts as the means for navigating and accessing the process parameters </li></ul><ul><li>Make recipes “machine readable” </li></ul>
    16. 16. Solution: Process Definition Editor <ul><li>ANSI/ISA 88 for standard look and feel for the “flowchart” user experience </li></ul><ul><li>Click on flowchart elements to define critical parameters in forms-based dialogs </li></ul><ul><li>BatchML for data representation </li></ul><ul><li>Purpose-built process definition editor supports key use cases </li></ul>Create Reusable Manufacturing Actions Author Process Definitions Document Process Parameters Transfer Technology Manage Knowledge
    17. 17. What is ISA-88 (“S88”)? <ul><li>Standard for: </li></ul><ul><ul><li>Graphical representation of batch manufacturing processes </li></ul></ul><ul><ul><li>Data representation </li></ul></ul><ul><li>Three models: physical, process, and control </li></ul><ul><li>Widely adopted in Batch Control and MES systems, so familiar to process engineers </li></ul><ul><li>Impact: </li></ul><ul><ul><li>Easy to use notation </li></ul></ul><ul><ul><li>Standardizes the representation of recipes upstream of manufacturing steps in the lifecycle </li></ul></ul>
    18. 18. What is BatchML? <ul><li>Standard maintained by the World Batch Forum for XML representation of data for all three ISA-88 models </li></ul><ul><li>Machine readable – supports transfer of ISA-88 data between systems </li></ul><ul><li>As an XML format, can be “rendered” to human-readable forms (e.g. a user interface or documents or both) </li></ul><ul><li>Impact: </li></ul><ul><ul><li>Captures all ISA-88 data including flows and parameters in a single format </li></ul></ul><ul><ul><li>Can be rendered to GUI as ISA-88, trees, forms; or to documents including eCTD for submissions, batch records, etc. </li></ul></ul><ul><ul><li>Provides a mechanism for content reuse – Recipe Building Blocks – which is critical to recipe normalization </li></ul></ul><ul><ul><li>Solves the technology transfer problem </li></ul></ul>
    19. 19. The Process Definition Editor BatchML storage of recipes and recipe building blocks ISA-88 Editor for visual editing and navigation of Process Definitions Drawing palettes for ISA-88 shapes and reusable components Double-click on shapes to drill down, add process parameters
    20. 20. Product Life Cycle Process Definition Pilot Scale Early Development Late Development Project Management LIMS / SDMS QMS / CAPA Lab Scale Electronic Lab Notebooks Users Project Operations Scientists Chemists Biologists Pharmacists Engineers Technicians Operators Support Analytical Quality MES ERP PLM Development Management Tech Transfer Clinical I Clinical II Clinical III Commercial Experiments Process Unit Procedures Commercial Scale Source: Mike Power, BearingPoint Process definition tools facilitate early process development 1 Process definitions refined, tech transfer at every point of scale 2 4 Tech transfer improved through machine-readable BatchML Process definitions transformed into ISA-88 control recipes in MES or Batch Control System 5 Manufacturing knowledge transferred to development through library of reusable process actions 6 ISA-88 recipes used for Description of Manufacturing Process & Process Controls (section 3.2.S.2.2) of CTD. 3
    21. 21. Proce s s Definition Editor <ul><li>Key Benefits </li></ul><ul><li>More rapidly create, edit, visualize, reuse data in recipes </li></ul><ul><li>Create / capture / reuse process knowledge </li></ul><ul><li>Facilitate Quality by Design </li></ul><ul><li>Improve CTD submissions </li></ul><ul><li>Improve technology transfer </li></ul><ul><li>Collaborate with CMOs </li></ul><ul><li>Accelerate time-to-market </li></ul>

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