Transforming Technology Transfer and Recipe Management: From Spreadsheets to Standardized Practices

Dynamic Information Now for Everyone©2008 JustSystems

Transforming Technology Transfer Transforming Technology Transfer and Recipe Managementand Recipe Management

From Spreadsheets to Standardized PracticesFrom Spreadsheets to Standardized Practices

Paul Wlodarczyk, VP Solutions Consulting, JustSystems

DocTrain Life Sciences

24 June 2008

2Dynamic Information Now for Everyone©2008 JustSystems

Business Imperative: Top ThreeBusiness Imperative: Top ThreeLife Science Innovation Goals for 2012 Life Science Innovation Goals for 2012 1. Leverage scientific/ technological advances to assure superior

therapeutic outcomes in their target patient population.

2. Improve acquisitions/ alliance / licensing management processes to improve agility in bringing new products to market.

3. Decrease the concept-to-patient lifecycle from the current 7-11 years to 5-7 years

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

ProductProduct

DemandDemand SupplySupply


ProcessDefinition

Pilot Scale

Early Development Late Development

Project Management

LIMS / SDMS

QMS / CAPA

Lab Scale

ElectronicLab

Notebooks

Users

Project Operations

Scientists Chemists

BiologistsPharmacistsEngineers

TechniciansOperators

Support

Analytical

Quality

MES

ERP

PLM

Development Management

TechTransfer

Clinical I Clinical II Clinical III

Commercial

Experiments

Process UnitProcedures

Product Life CycleProduct Life Cycle

Commercial Scale

Source: Mike Power, BearingPointProductProduct



Business Processes Impacting Time-to-Market:Business Processes Impacting Time-to-Market:Early Stage Product and Process Innovation Early Stage Product and Process Innovation

Knowledge of Knowledge of FutureFuture Manufacturing Manufacturing EnvironmentEnvironment

• Result = foundation of process knowledge• Goal = predict manufacturing performance under

commercial operating conditions

Manage Process

Knowledge Creation

Knowledge Knowledge of Chemistry,of Chemistry,Microbiology,Microbiology,PhysicsPhysics

ProcessProcessRequirementsRequirements• Meets cGMP?Meets cGMP?• Safe?Safe?• CommerciallyCommercially viable?viable?

common information modelsManage Process

Knowledge Discovery

Early Stage Product and Process Development: Lab to Bench Scale Pilot

Source: Alison Smith, AMR Research

Rapid IterationsRapid Iterations

ProductProduct



ProductProduct


Business Processes Impacting Time-to-Market: Business Processes Impacting Time-to-Market: Late Stage Process Development Late Stage Process Development through Ramp to Commercial Manufacturingthrough Ramp to Commercial Manufacturing

Foundation of Foundation of preliminary preliminary process process knowledgeknowledge

Experience in Experience in ExistingExistingManufacturing Manufacturing EnvironmentEnvironment

Process ImprovementsProcess Improvements• Improves yield?Improves yield?• Reduces variability?Reduces variability?• Commercially Commercially

viable?viable?

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


Opportunity to use ISA-88 recipe as the common information

model for process definitions?

““Master Data”: Master Data”: Coordination Points for ManufacturingCoordination Points for Manufacturinginclude both Product and Process include both Product and Process

Supply

Demand

Product Design/FormulationDesign/Formulation

Marketing CollateralMarketing Collateral

Service DocsService DocsData SyncData Sync

E-CommerceE-Commerce

Order Acquisition & ManagementOrder Acquisition & Management

Supply ChainSupply ChainPlanning (mBOM, Routing)Planning (mBOM, Routing)

Sourcing & ProcurementSourcing & Procurement

ProductPackage Design/ Label Package Design/ Label

ClaimsClaims

Recipe ManagementRecipe Management

Detailed RoutingDetailed Routing

Bill of EquipmentBill of Equipment

Bill of ProcessBill of Process

Bill of Compliance/ CoABill of Compliance/ CoA

Bill of TestBill of Test

Asset MaintenanceAsset Maintenance

Bill of MaterialsBill of Materials

Process SpecificationsProcess Specifications

Process EngineeringProcess Engineering

Maintenance PlansMaintenance Plans

SOPsSOPs

Asset Performance ManagementAsset Performance Management





comm

on information m

odels


ISA-88 OperationsISA-88 OperationsIce Cream Recipe ExampleIce 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)


A Solution for Faster Time to MarketA Solution for Faster Time to Market

• Process Definition Management• Define all recipes in a common

information model• Build a library of Reusable Manufacturing

Actions• Assemble new Recipes from components

in library

• Benefits:• Standardize on Good Manufacturing

Practices• Feedback loop from Manufacturing to

Development• Improved technology transfer• Process Knowledge Management • Bottom line: Quality by Design, Faster

time to market

Development Process Library

Execution Systems

Operator Instructions

Submission Ready Components

Contract Manufacturing

Structured Data Sources

Common Steps & Actions

Common Steps & Actions

Commercial Process Library


Key Use Cases in Key Use Cases in Process Definition Management Process Definition Management

1. Create Reusable Manufacturing Actions (RMAs)

2. Author Process Definitions (“Recipes”)3. Document Process Parameters4. Transfer Technology 5. Manage Knowledge

Create Reusable

Manufacturing Actions

Author Process

Definitions

Document Process

Parameters

Transfer Technology

Manage Knowledge


Create Reusable Manufacturing ActionsCreate Reusable Manufacturing Actions

• Challenges:• Process Definition Management requires reuse of codified content

(RMAs or recipe building blocks)

• No best practice for representing recipes and RMAs outside of manufacturing

• No method for implementing reuse

Impacts:Benefits of recipe normalization are not achieved during Discovery and Clinical phases of lifecycle – time and money left on the table

Create Reusable


Author Process

Definitions

Document Process

Parameters

Transfer Technology

Manage Knowledge


Author Process Definitions (“Recipes”)Author Process Definitions (“Recipes”)

• Challenges:• No practice for representing process definitions outside of Batch Control

(where ISA-88 is the standard)

• No “purpose-built” tools – just spreadsheets and flowcharts

• Automation requires custom development

• Parameters and flows managed as large documents

Impacts: Low authoring productivity. Authoring recipes takes months.Difficult to track changes at an elemental level. No audit trailAutomation requires software development and maintenance

Create Reusable


Author Process

Definitions

Document Process

Parameters

Transfer Technology

Manage Knowledge


Document Process ParametersDocument Process Parameters

• Challenges:• Parameters authored separately from process flows • Spreadsheets are the current best practice – but are 1000s of rows long• No way to link to or standardize “Bills of X”• No established best practice for regulatory reporting of CTQ / KTQs

Impacts:Low authoring productivity, no way to track/maintain parameters

No element-level change management or audit trail

Disconnected from systems of record

Difficulty supporting Quality by Design

Create Reusable


Author Process

Definitions

Document Process

Parameters

Transfer Technology

Manage Knowledge


Technology TransferTechnology Transfer

• Challenges:• Process definitions are represented in human-readable documents, not

available as data

• Recipes need to be manually entered into Batch Control and execution systems

Impact:Ineffective and inefficient technology transfer

QualityYieldCycle time

Create Reusable


Author Process

Definitions

Document Process

Parameters

Transfer Technology

Manage Knowledge


Process Knowledge ManagementProcess Knowledge Management

• Challenges:• Document-based approaches to recipe representation

• Discovery requires full-text keyword search

Impacts:Barriers to information discovery and knowledge sharing

Sharing of Good Manufacturing Practices is manual, uneven – lost productivity, gains are not repeatable

No common method of representing “manufacturing process IP”

No mechanism for IP management

Create Reusable


Author Process

Definitions

Document Process

Parameters

Transfer Technology

Manage Knowledge


What is the Recipe for What is the Recipe for Addressing these Issues?Addressing these Issues?

• Create a purpose-built process definition editor

• Make documents “componentized”

• Enable valuable content to be extracted and reused from recipes (for knowledge management, RMA, etc.)

• Use SFC flowcharts as the means for navigating and accessing the process parameters

• Make recipes “machine readable”


Solution: Solution: xfy Process Definitionxfy Process Definition

• ANSI/ISA 88 for standard look and feel for the “flowchart” user experience

• Click on flowchart elements to define critical parameters in forms-based dialogs

• BatchML for data representation• Purpose-built process definition

editor supports key use cases

Create Reusable


Author Process

Definitions

Document Process

Parameters

Transfer Technology

Manage Knowledge


What is ISA-88 (“S88”)?What is ISA-88 (“S88”)?

• Standard for:• Graphical representation of batch manufacturing

processes• Data representation

• Three models: physical, process, and control• Widely adopted in Batch Control and MES systems,

so familiar to process engineers

Impact:Easy to use notationStandardizes the representation of recipes upstream of manufacturing steps in the lifecycle


What is BatchML?What is BatchML?

• Standard maintained by the World Batch Forum for XML representation of data for all three ISA-88 models

• Machine readable – supports transfer of ISA-88 data between systems

• As an XML format, can be “rendered” to human-readable forms (e.g. a user interface or documents or both)

Impact:Captures all ISA-88 data including flows and parameters in a single format

Can be rendered to GUI as ISA-88, trees, forms; or to documents including eCTD for submissions, batch records, etc.

Provides a mechanism for content reuse – Recipe Building Blocks – which is critical to recipe normalization

Solves the technology transfer problem


The xfy Process Definition SolutionThe xfy Process Definition Solution

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


ProcessDefinition

Pilot Scale

Early Development Late Development

Project Management

LIMS / SDMS

QMS / CAPA

Lab Scale

ElectronicLab

Notebooks

Users

Project Operations

Scientists Chemists

BiologistsPharmacistsEngineers

TechniciansOperators

Support

Analytical

Quality

MES

ERP

PLM

Development Management

TechTransfer

Clinical I Clinical II Clinical III

Commercial

Experiments

Process UnitProcedures

Product Life CycleProduct Life Cycle

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


xfy Process Definition Editor

Key Benefits• More rapidly create, edit, visualize, reuse data in recipes• Create / capture / reuse process knowledge • Facilitate Quality by Design• Improve CTD submissions• Improve technology transfer• Collaborate with CMOs• Accelerate time-to-market


• Global Presence• 1,000 employees, FY ‘07 revenues of $110M

• HQ in Japan, offices in North America (NJ, Vancouver) and Europe (London)

• Our Experience• Established in 1979

• Market leader with over 2,500 customers

• Our Expertise• Global provider of desktop productivity,

information management, consumer & enterprise software

• Framework for XML-based content creation, integration, visualization and delivery

• Our Financial Strength• Established and growing company

2,500 Customers,Marquee Brands

JustSystems


For more information

• Visit our website:• http://na.justsystems.com/lifesciences

• Email us:• [email protected]

• Call us:• (866) 793-1542