072604.1 Moore 1

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BioIreland Conference Nov 2006
Centocor A Case Study for Biomanufacturing in
Ireland Paul Treacy Vice-President General
Manager Centocor Biologics
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Contents

• Johnson Johnson in Ireland
• Centocor Cork Project Scope
• Lessons Learned

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Johnson Johnson The Company

• Most broadbased healthcare company in the World
• 2005 Revenues 50.51 Billion
• 115,000 employees
• Manufacturing Operations in Europe, North
  America, South America, Australia, and Asia
• Annual RD expenditure 4 Billion

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Johnson Johnson Ireland

• Celebrated 70 years in Ireland in 2005
• 6 manufacturing operations in Ireland
• Over 2000 Employees

Medical Devices
Pharma Chem
Biotechnology

• DePuy
• Cordis
• Vistakon

• Janssen
• Alza

• Centocor

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Cork Plant Scope

• Greenfield Manufacturing Site
• JJs 5th bulk Biotech plant
• Multi Product Capable
• Capital spend 735 Million
• Capable of producing 480 Kgs Product per Year
• New Generation of Products
• CNTO 148 (Next Generation of REMICADE)
• CNTO 1275
• Other New Molecular Entities currently in RD
  pipeline
• Employment 311 permanent staff contractors
• 60-70 of employees will be 3rd level qualified,
  10 will be 4th level qualified.

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Cork Plant Timeline
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Building Schematics
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August 2005
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September 05
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November 05
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BioIreland Conference Nov 2006
Application of Lessons Learned (Why are large
scale bio/pharma construction projects so
difficult to execute?)
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Learning From Past Mistakes

• Most common mistake involving large
  Biotech/pharma construction projects has been the
  failure to have experienced users involved in the
  initial design of the plant.
• Second most common mistake is not adequately
  capturing user input and translating it into the
  engineering design and construction
• The third most common mistake is not giving the
  same priority to developing operational readiness
  as is given to project construction and
  qualification
• gt Why have these simple mistakes been repeated
  over and over again?

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Learning From Past Mistakes

• The principal reason why users are not involved
  early in plant design is due to differing
  abilities of various project groupings to
  mobilize
• gt Contract Design Houses, Construction Companies
  Owner Engineering depts can invariably mobilize
  much faster than user groups

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Traditional Project Mobilization
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User Input

• Not having Appropriate and Timely user input can
  lead to
• Schedule impacts due to redesign and rework
• Cost overruns due to redesign and rework
• Processes that are difficult to validate
• Capacity that is less than expected
• Quality and compliance levels that are not to
  required standards

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Centocor Plant Mobilization Solution
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Temporary User Concept
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Learning From Past Mistakes

• Most common mistake involving large
  Biotech/pharma construction projects has been the
  failure to have experienced users involved in the
  initial design of the plant.
• Second most common mistake is not adequately
  capturing user input and translating it into the
  engineering design and construction
• The third most common mistake is not giving the
  same priority to developing operational
  readinness as is given to project construction
  and qualification

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Capturing the Voice of the Customer

• How can we ensure that the voice of the customer
  is captured?

• Use of Design Excellence
• A method for systematically capturing and
  integrating user input into the design,
  construction and validation effort.

• Janssen P3 was the first large-scale
  manufacturing construction project in JJ to
  employ Design Excellence
• Centocor Cork is the 2nd project.

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Use of Design Excellence
Voice of the Customer
Stakeholders
Customers/Users
GMP Requirements
Non-GMP Requirements
High Level requirements
Low Level requirements
URS
DeX Scorecard
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Benefits of Design Excellence
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Learning From Past Mistakes

• Most common mistake involving large
  Biotech/pharma construction projects has been the
  failure to have experienced users involved in the
  initial design of the plant.
• Second most common mistake is not adequately
  capturing user input and translating it into the
  engineering design and construction
• The third most common mistake is not giving the
  same priority to developing operational readiness
  as is given to plant construction and
  qualification

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Integrated Project Management
Project Master schedule is divided into the
following Sub-Projects
But..there is something missing! The schedule
above concentrates predominately on building the
plant. The critical missing piece is preparing
the plant to operate in an efficient,
cost-effective and compliant fashion when it is
handed over.
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Merge Operational Readiness Effort into Master
Project Schedule
Project Directors
Site Leadership Team
Operational Readiness Teams

• Construction
• Tech Transfer

• Identify
• Tasks
• Milestones
• Interdependances
• Resources

BioCork Integrated Schedule
Merge
Fully Integrated Project/Plant Management Process
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Fully Integrated Project Schedule
Master Project Schedule
Commissioning
Qualification Validation
Operational Readiness
Construction
Design
Operational Readiness Teams
Project Directors
Owners/users
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Operational Readiness Teamsexamples

• EHS Steering
• EHS Committee
• Sarbanes Oxley
• Maintenance Exellence
• Change Management (system development)
• Deviation Management (system development)
• Process Mapping
• Process Information Systems

• Training
• Communications
• Documentation
• Labelling
• SAP Preventative Maintenance
• HR Time attendance
• SAP ERP
• Records Management
• Asset Management
• Vendor Management

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Progress To Date

• Currently starting Commissioning
• Project is on schedule
• Project is on budget