abbvie spec & agro 2016 - abbvie contract manufacturing · downstream processing . ... whole...
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FERMENTATION CAPABILITIES
Sep 7, 2016
AbbVie: A Leading Global Biopharmaceutical Company
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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
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Sales: $22.8B (YE 2015)
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: 13 State-of the-art global manufacturing facilities
North America & Europe & Singapore
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: Toll Manufacturing Embedded business unit built on a strong foundation and broad manufacturing capabilities.
Objective: Commercial manufacturing
Commitment: o Sales > $500 Million/year o More than 25 years of tolling
experience o Global Operation
Markets served: o Agrochemicals o Pharmaceuticals o Nutriceuticals/Dietary Supplements o Food Ingredients o Industrial Applications
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AbbVie: Manufacturing Locations
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1 Ludwigshaven, Germany Campoverde, Italy 4 8 Wyandotte, Michigan, USA
2 Sligo, Ireland 5 Lake County, Illinois, USA 9 Barcelonetta, Puerto Rico 3 Cork, Ireland 6 North Chicago, Illinois, USA 10 Jayuya, Puerto Rico
7 Worcester, Mass., USA
NORTH CHICAGO FERMENTATION OPERATIONS
AbbVie: North Chicago at a Glance History: Started as Abbott manufacturing site
in 1920’s and started fermentation in 1940’s.
Size: ~ 0.75 km2 (180 acres)
Purpose: - HQ for AbbVie Operations and Tolling - Fermentation Operations - Primary QA release site for region - Pharmaceutical R&D
People: ~1,500 employees at the Site ~400 Employees Supporting Fermentation
Products: Majority are for contract customers ~40 Different Types of Products in Powder or Liquid Forms
Customers: >50 different customers served
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Raw Materials • Close proximity to natural raw material
sources • Rail spur for receipt of raw materials • On-site procurement and raw materials
testing on-site
Solvents • On site bulk solvent tank farms with
storage of >2,000,000 Liters • On-site solvent recovery • Able to handle HAP solvents
Utilities • Access to Lake Michigan for cooling
water with back-up chillers • Double-ended grid supplied electricity • Natural gas supply • Steam generation
Capabilities. Performance. Commitment. Site Infrastructure
Waste Treatment • Anaerobic and aerobic basins for
treatment prior to sending to public treatment
• On-Site Hazardous Waste Management • Odor control
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Capabilities. Performance. Commitment. Cell Banks & Inoculum
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Experience with many different types of organisms including: • Actinomycetes • E. coli • Fungi • Bacillus spp.
Currently manufacturing using genetically modified organisms: • Institutional Biosafety Committee review per NIH guidelines • Organisms would need to meet GLSP criteria
Preparation of master and working cell banks: • Compliant with ICH Q7 for API manufacturing • Cell Bank maintenance with backup and redundant equipment/controls
Inoculum process development: • Streamlined, robust processes for consistent inoculum performance.
Strain improvement programs via: • Classical techniques • Recombinant techniques
Fermenters
38 total fermenters Sizes ranging from 19 – 135 m3
Total capacity > 3000 m3
Primary size is 135 m3
Additional Tankage Seed tanks (1 to 12 m3) Feed tanks Formulation tanks
Sterilizers Media sterilizers (continuous) Seed media sterilizer
Oil sterilizer
Capabilities. Performance. Commitment. Fermentation
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Monitoring/Controls OSI-PI software for web based access Temp, agitation, pH, DO, off gas.
10
Broth Separation
Scroll Decanters
Microfiltration
Disk Stack Centrifuges
Belt Filter
Capabilities. Performance. Commitment. Downstream Processing
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Extraction
Whole Broth Extraction Podbielniak Liquid-Liquid Extractors
Westfalia Liquid-Liquid Extractors
Concentration
Reverse Osmosis
Thin Film Evaporation
Flash Evaporators
Mechanical Vapor Recompression (MVR)
Reactors
Large, agitated and jacketed
reactors with sizes ranging
from (1-10 m3)
Capabilities. Performance. Commitment. Downstream Processing
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Purification
Chromatography Ion Exchange (Adsorption)
Ultrafiltration
Decolorization
Sweco Sifters
Capabilities. Performance. Commitment. Downstream Processing
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Filtration & Isolation Cartridge and Depth Filtration
Crystallization
Filter Press Basket Centrifugation
Filter Pot
Drying/Bulk Packaging
Blender Dryers
Fluid Bed Dryers
Tray Dryer
Filter Dryer
Milling
Dry Blending
Capabilities. Performance. Commitment. Downstream Processing
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AbbVie offers the full spectrum of fermentation development capabilities including:
Robust & Efficient
Manufacturing Process and
Product
Capabilities. Performance. Commitment. Technical Transfer and Development
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Strain Improvement
Method Development
• Method development and validation for analytical, microbiological and cleaning methods
Recovery Process Development
Fermentation Process
Development and Characterization
• Strain improvement via classical and recombinant techniques
• Process development and characterization at lab and pilot scales from 10 L – 750 L
• Customizable recovery process development for extraction, crystallization, blending, drying, and milling.
60+ years developing and optimizing fermentation manufacturing processes
Capabilities 56 pilot scale (55 L) fermenters
Permanent staff dedicated to pilot plant operations
Identical software as commercial production (OSI PI): • Temperature, agitation, pH, DO and
off-gas. • Frequently scale directly from 55 L
to 100,000 L commercial scale
Expertise Personnel are expert in process development and scale-up, running hundreds of pilot batches every year
Average experience at the pilot plant is 20+ years
Capabilities. Performance. Commitment. Pilot Plant
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Highly experienced staff provide method development, validation and transfer services, as well as submission, audit and manufacturing support HPLC (reverse/normal phase and ion exchange, with UV/Vis, RI, fluorescence, ECD and ELS detection)
GC (direct injection and headspace analysis with FID and TCD detection)
Ion Chromatography
GC-MS and LC-MS
Spectroscopy (FT-IR, UV/Vis and AA)
ICP-OES and ICP-MS Powder X-Ray Diffraction, TGA and DSC
Optical and Electron Microscopy
Surface Area and Particle Size Analysis
ICH and Development Stability Chambers
Cleaning Methods (LC and TOC)
Microbiology Lab for product testing and facility environmental testing.
Capabilities. Performance. Commitment. Analytical and Microbiological Testing
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• OSHA Recordable
• Lost Time Injuries
• Near Misses
• Spills
• Loss of Primary Containment
• EPA Notice of
Violations
• Right the First Time
• Lot Non-
Conformances • Number of
Exceptions
• Exceptions Closed On-Time
• Number of
Complaints
• Complaint Closure Rate
Measuring Excellence Environmental Quality Scheduling Health & Safety
• On-Time Delivery to Approved Stock
• On-Time
Purchase and Receipt of Materials
• On-Time Start
• On-Time Finish
• On-Time Release
Capabilities. Performance. Commitment.
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Productivity
• Titer by Product
• Recovery Yield
by Product • Foreign
Growth • Equipment
Utilization • Labor
Utilization
Equipment Maintenance • % Repair
Related Downtime
• % PM Scheduling
• PM Completion
On-Time • Spare Parts
Availability
GOAL: On-Time, Consistent Supply to Our Customers
Capabilities. Performance. Commitment. EH&S
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1
0
2
5
4
3
2013 2014 2015 2016 YTD
Num
ber o
f Occ
urre
nces
OSHA Recordable
Lost Time Injuries
Capabilities. Performance. Commitment. Quality
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• Greater than 1000 fermentation runs per year • Excludes fermentation runs lost due to foreign growth
0
1
2
2013 2014 2015 2016 YTD
Number of Non-Conforming Lots
98.0%
98.5%
99.0%
99.5%
100.0%
2013 2014 2015 2016 YTD
% Right the First Time
20
Capabilities. Performance. Commitment. Productivity
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% Foreign Growth 5.0%
4.0%
3.0%
2.0%
1.0%
0.0% 2013 2014 2015 2016
• Greater than 1000 fermentation runs per year
Capabilities. Performance. Commitment. Scheduling
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% On-Time Delivery to Approved Finished Goods
100.0%
97.0%
94.0%
91.0%
88.0%
85.0% 2013 2014 2015 2016 YTD
• Greater than 1000 fermentation runs per year
Capabilities. Performance. Commitment. Business Excellence
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Class A Certification (2007/2011/2014) Based on Oliver Wight manufacturing philosophy
KPIs to ensure performance
Master production schedule conformance
Supply plan achievement
Data accuracy
New product introduction milestone achievement Perfect index
Right the first time
EHS index
Customer service
Days on hand
Business Processes established New product introduction
Master production scheduling
Material ordering and inventory management
Supply and operations planning meetings
Monthly management reporting system
Continuous Improvement Tools Utilized Kaizen Root Cause Problem Solving 5S Six Sigma
Dedicated Internal Business Excellence Organization
Personnel
Policies and routine training on handling of confidential information
Employees required to sign a confidential agreement upon hiring.
AbbVie has many layers to ensure your proprietary information is safe:
Physical 24/7 On-site Security
Gated Site
Video Surveillance
Badge Access For Each Building
Cell Banks Are Under Lock and Key with Restricted Access
Manufacturing Documents in Controlled File Area
Capabilities. Performance. Commitment. Security
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Cyber All computers are virus protected
All shared sites password protected with restricted access
Proposal Stage: Program execution: Initial evaluation for site fit
• EH&S • Organism • Scale • Commercial
Process Evaluation for equipment fit • Commercial pricing estimate • Capex estimates
Tech Transfer Proposal • Tailored to customers needs; can
include detailed activities with sub- stages
• Timelines • Defined success criteria
Letter of Intent/Supply Agreement • LOI enables immediate transfer • Project governance
Manage the successful implementation of products into manufacturing
• Develop project plan and schedule
• Form project team
• Kick-off meeting
• Facilitate team meetings
• Track progress against milestones
• Report to Governance Committee
Communication • Routine meetings
• Face to face visits/telecon/webex
• Sharepoint site development
• Elevation strategy
• Engaged senior leadership
Capabilities. Performance. Commitment. Customer Experience
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Stable and committed partner with 25+ years tolling experience
65+ years of classical fermentation expertise and know-how
Established site infrastructure to ensure reliable supply
Proven ability to consistently meet delivery commitments
Robust compliance and business processes
Excellent environmental, health and safety record
Strong culture of continuous improvement
Trusted partner to maintain confidentiality
Capabilities. Performance. Commitment. AbbVie Fermentation – Your Preferred Partner
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AbbVie Contract Manufacturing 1401 Sheridan Road North Chicago, IL 60064 USA USA: +1 800 240 1043 Outside USA: +1 847 938 8524 [email protected] www.abbviecontractmfg.com