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AbbVie: A Leading Global Biopharmaceutical Company
TRADITIONAL PHARMA
BIOTECH
The expertise, financial stability and resources to effectively commercialize products
The focus, culture and innovative spirit to achieve breakthrough science
FOCUSED
PASSIONATE
REMARKABLE IMPACT
ABBVIE
A GLOBAL BIOPHARMACEUTICAL
COMPANY
BIOTECH TRADITIONAL PHARMA
AbbVie established independently from Abbott Laboratories in January 2013 A publically traded company (NYSE ticker ABBV)
AbbVie: Corporate Overview Sales: $19.96B (YE 2014)
Experience: Biopharmaceutical organization with leading scientific experience People: 28,000+ employees Global understanding: 30 commercial products in 170+ countries
>120+ years of pharmaceutical development and manufacturing Offer both specialized and standard type manufacturing
Plants: 12 State-of the-art global manufacturing facilities
North America & Europe (Singapore under construction)
Reliability: Exceptional Quality, Regulatory and Delivery track record
Long term Vision: Investing in success
Therapeutic Areas of Focus: Immunology, Kidney Disease, Liver Disease, Neuroscience and Oncology
AbbVie Contract Manufacturing Organization (CMO) Toll Manufacturing
Embedded CMO business unit built on a strong foundation and broad manufacturing capabilities.
Commitment. o Sales: > $500MM/year o > 25 years of CMO experience o Global Operation o Top 10 CMO globally on revenue basis
Markets served: o Pharmaceuticals o Nutraceuticals o Food additive o Chemical applications
Key CMO Differentiator: Broad Service Menu and Deep Technical Depth
Capabilities. Development & Manufacturing: - Biologics (Monoclonal Antibody) - APIs (Small Molecule) - Classical Microbial Fermentation - Drug Product - Hot Melt Extrusion (HME) Service Consolidation - Potent (API and Drug Product) with top performing CMO - Prefilled Syringes - Controlled Drug (DEA) - Packaging
Performance. Industry Recognized Reliability. - 2011-2014 CMO Life Sciences Leadership Award - Ranked within the top 3% of CMOs globally
AbbVie Contract Manufacturing / Toll Manufacturing Commitment. Capabilities. Performance.
Confidential
AbbVie Manufacturing Sites Commitment. Capabilities. Performance.
Drug Product Lake County, IL USA Barceloneta, Puerto Rico Campoverde, Italy Ludwigshafen, Germany Sligo, Ireland Cork, Ireland Wyandotte, MI USA
Fermentation (Classical) North Chicago, IL USA
Biologics (Monoclonal Antibodies )
Worcester, MA USA Barceloneta, Puerto Rico
APIs Campoverde, Italy Sligo, Ireland North Chicago, IL USA Wyandotte, MI USA
AbbVie Client Management Commitment. Capabilities. Performance.
Proposal Stage: Evaluate existing Process Description
Perform Facility Fit Evaluation: compare process and process parameters to existing equipment, capacities, capabilities to identify:
– Existing equipment that can be used as is
– Equipment that needs to be modified prior to use
– Equipment that needs to be purchased
– Unit operations that need to be optimized to fit facility
– New raw materials – EH&S evaluation
Create detailed project plan and budget
Program execution: Manage the successful implementation of
projects into manufacturing
Achieve Contract Commitments
Provide effective communication between Customer and AbbVie
Develop Project Plan and Schedule
Form Commercial Project Team
Facilitate Team Meetings
Transfer detailed project information and data
Track progress, action items and project milestones
Transition to Account Management after Commercial Launch
Confidential
Class A Certification (2007/2011/2014) based on Oliver Wight Manufacturing Philosophy
KPIs in place to monitor business processes
Master Production Schedule conformance
Supply Plan Achievement
Data Accuracy
New Product Introduction Milestone Achievement
Perfect Index
Right First Time
EHS Index
Customer Service
Days on Hand
Commitment. Capabilities. Performance.
Business Processes established New Product Introduction
Master Production Scheduling
Material Ordering and Inventory Management
Monthly Management Reporting System Continuous Improvement Tools Utilized Kaizen RCPS – Root Cause Problem Solving 5S Six Sigma Total Productive Maintenance Program
Dedicated Internal Business Excellence Organization
AbbVie Continuous Improvement
Operational Excellence
• Perfect Index
• Safety Performance
• Operational Excellence
• Maintenance Excellence (MEP)
• Quality Index
• Scheduling Index
• Zero Loss Time and OSHA driven by focused improvement plans
Customer Satisfaction
• No backorder to patients
• Achieving customer service levels > 98% . On time and in full order fulfillment
• Flawless Execution of Launches
• Equipment investment
• Quarterly Business Reviews
• Cost Improvement Programs (CIP)
Assurance of Supply
• Regulatory and customer inspections
• Zero High Impact Complaints
• Zero Product Actions
• Monthly management and customer reviews of deliveries
Commitment. Capabilities. Performance. Performance
AbbVie CMO
Benefits to our Partners Dedicated CMO with Broad Service Menu and Deep Technical Depth, impact on:
Time Cost Resource
Diverse Manufacturing Network for ease in global launch and supply Reliable supplier with superior quality record WE INVITE YOU TO DRAW ON ABBVIE’s CMO EXPERIENCE visit us at ChemSpec booth # A01 or at www.abbviecontractmfg.com