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FERMENTATION CAPABILITIES Sep 7, 2016
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Page 1: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

FERMENTATION CAPABILITIES

Sep 7, 2016

Page 2: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

AbbVie: A Leading Global Biopharmaceutical Company

AbbVie | Company Confidential © 2016 2

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)

Page 3: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

AbbVie: Corporate Overview

AbbVie | Company Confidential © 2016 3

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

Page 4: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

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

AbbVie | Company Confidential © 2016 4

Page 5: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

AbbVie: Manufacturing Locations

AbbVie | Company Confidential © 2016 5

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

Page 6: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

NORTH CHICAGO FERMENTATION OPERATIONS

Page 7: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

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

AbbVie | Company Confidential © 2016 7

Page 8: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

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

AbbVie | Company Confidential © 2016 8

Page 9: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

Capabilities. Performance. Commitment. Cell Banks & Inoculum

AbbVie | Company Confidential © 2016 9

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

Page 10: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

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

AbbVie | Company Confidential © 2016

Monitoring/Controls OSI-PI software for web based access Temp, agitation, pH, DO, off gas.

10

Page 11: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

Broth Separation

Scroll Decanters

Microfiltration

Disk Stack Centrifuges

Belt Filter

Capabilities. Performance. Commitment. Downstream Processing

AbbVie | Company Confidential © 2016 11

Extraction

Whole Broth Extraction Podbielniak Liquid-Liquid Extractors

Westfalia Liquid-Liquid Extractors

Page 12: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... 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

AbbVie | Company Confidential © 2016 12

Page 13: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

Purification

Chromatography Ion Exchange (Adsorption)

Ultrafiltration

Decolorization

Sweco Sifters

Capabilities. Performance. Commitment. Downstream Processing

AbbVie | Company Confidential © 2016 13

Page 14: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

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

AbbVie | Company Confidential © 2016 14

Page 15: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

AbbVie offers the full spectrum of fermentation development capabilities including:

Robust & Efficient

Manufacturing Process and

Product

Capabilities. Performance. Commitment. Technical Transfer and Development

AbbVie | Company Confidential © 2016 15

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

Page 16: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

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

AbbVie | Company Confidential © 2016 16

Page 17: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

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

AbbVie | Company Confidential © 2016 17

Page 18: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

• 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.

AbbVie | Company Confidential © 2016 18

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

Page 19: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

Capabilities. Performance. Commitment. EH&S

AbbVie | Company Confidential © 2016 19

1

0

2

5

4

3

2013 2014 2015 2016 YTD

Num

ber o

f Occ

urre

nces

OSHA Recordable

Lost Time Injuries

Page 20: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

Capabilities. Performance. Commitment. Quality

AbbVie | Company Confidential © 2016

• 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

Page 21: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

Capabilities. Performance. Commitment. Productivity

AbbVie | Company Confidential © 2016 21

% 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

Page 22: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

Capabilities. Performance. Commitment. Scheduling

AbbVie | Company Confidential © 2016 22

% 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

Page 23: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

Capabilities. Performance. Commitment. Business Excellence

AbbVie | Company Confidential © 2016 23

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

Page 24: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

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

AbbVie | Company Confidential © 2016 24

Cyber All computers are virus protected

All shared sites password protected with restricted access

Page 25: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

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

AbbVie | Company Confidential © 2016 25

Page 26: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

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

AbbVie | Company Confidential © 2016 26

Page 27: AbbVie Spec & Agro 2016 - AbbVie Contract Manufacturing · Downstream Processing . ... Whole Broth Extraction : Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors

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


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