FERMENTATION CAPABILITIES. Sep 7, 2016

Transcription

1 FERMENTATION CAPABILITIES Sep 7, 2016

2 AbbVie: A Leading Global Biopharmaceutical Company AbbVie established independently from Abbott Laboratories in January 2013 A publically traded company (NYSE ticker ABBV) ABBVIE TRADITIONAL PHARMA A GLOBAL BIOPHARMACEUTICAL COMPANY BIOTECH The expertise, financial stability and resources to effectively commercialize products FOCUSED PASSIONATE REMARKABLE IMPACT The focus, culture and innovative spirit to achieve breakthrough science AbbVie Company Confidential

3 AbbVie: Corporate Overview Sales: $22.8B (YE 2015) Experience: People: Plants: Biopharmaceutical organization with leading scientific experience 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 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 Company Confidential

4 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

5 AbbVie: Manufacturing Locations 1 Ludwigshaven, Germany 4 Campoverde, Italy 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 AbbVie Company Confidential

6 NORTH CHICAGO FERMENTATION OPERATIONS

7 AbbVie: North Chicago at a Glance History: Started as Abbott manufacturing site in 1920 s and started fermentation in 1940 s. Size: Purpose: People: Products: Customers: ~ 0.75 km 2 (180 acres) - HQ for AbbVie Operations and Tolling - Fermentation Operations - Primary QA release site for region - Pharmaceutical R&D ~1,500 employees at the Site ~400 Employees Supporting Fermentation Majority are for contract customers ~40 Different Types of Products in Powder or Liquid Forms >50 different customers served AbbVie Company Confidential

8 Site Infrastructure 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 Waste Treatment Anaerobic and aerobic basins for treatment prior to sending to public treatment On-Site Hazardous Waste Management Odor control AbbVie Company Confidential

9 Cell Banks & Inoculum 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 AbbVie Company Confidential

10 Fermentation Fermenters 38 total fermenters Sizes ranging from m 3 Total capacity > 3000 m 3 Primary size is 135 m 3 Additional Tankage Seed tanks (1 to 12 m 3 ) Feed tanks Formulation tanks Sterilizers Media sterilizers (continuous) Seed media sterilizer Monitoring/Controls OSI-PI software for web based access Temp, agitation, ph, DO, off gas. Oil sterilizer AbbVie Company Confidential

11 Downstream Processing Extraction Whole Broth Extraction Podbielniak Liquid-Liquid Extractors Westfalia Liquid-Liquid Extractors Broth Separation Scroll Decanters Microfiltration Disk Stack Centrifuges Belt Filter AbbVie Company Confidential

12 Downstream Processing 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) AbbVie Company Confidential

13 Downstream Processing Purification Chromatography Ion Exchange (Adsorption) Ultrafiltration Decolorization Sweco Sifters AbbVie Company Confidential

14 Downstream Processing 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 AbbVie Company Confidential

15 Technical Transfer and Development AbbVie offers the full spectrum of fermentation development capabilities including: Strain improvement via classical and recombinant techniques Strain Improvement 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. Fermentation Process Development and Characterization Robust & Efficient Manufacturing Process and Product Method Development Method development and validation for analytical, microbiological and cleaning methods Recovery Process Development 60+ years developing and optimizing fermentation manufacturing processes AbbVie Company Confidential

16 Pilot Plant 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 AbbVie Company Confidential

17 Analytical and Microbiological Testing 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. AbbVie Company Confidential

18 OSHA Recordable Lost Time Injuries Near Misses Spills Capabilities. Performance. Commitment. Measuring Excellence Environmental Quality Scheduling Health & Safety 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 On-Time Delivery to Approved Stock On-Time Purchase and Receipt of Materials On-Time Start On-Time Finish On-Time Release 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 AbbVie Company Confidential

19 EH&S 5 Number of Occurrences OSHA Recordable Lost Time Injuries YTD AbbVie Company Confidential

20 Quality 2 Number of Non-Conforming Lots 100.0% 99.5% % Right the First Time % 98.5% YTD 98.0% YTD Greater than 1000 fermentation runs per year Excludes fermentation runs lost due to foreign growth AbbVie Company Confidential

21 Productivity 5.0% 4.0% % Foreign Growth 3.0% 2.0% 1.0% 0.0% Greater than 1000 fermentation runs per year AbbVie Company Confidential

22 Scheduling 100.0% 97.0% 94.0% 91.0% 88.0% % On-Time Delivery to Approved Finished Goods 85.0% YTD Greater than 1000 fermentation runs per year AbbVie Company Confidential

23 Business Excellence 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 AbbVie Company Confidential

24 Security 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 Personnel Policies and routine training on handling of confidential information Employees required to sign a confidential agreement upon hiring. Cyber All computers are virus protected All shared sites password protected with restricted access AbbVie Company Confidential

25 Customer Experience Proposal Stage: Program execution: Initial evaluation for site fit EH&S Organism Scale Commercial Process Evaluation for equipment fit Commercial pricing estimate Capex estimates 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 Tech Transfer Proposal Tailored to customers needs; can include detailed activities with substages Timelines Defined success criteria Letter of Intent/Supply Agreement LOI enables immediate transfer Project governance Communication Routine meetings Face to face visits/telecon/webex Sharepoint site development Elevation strategy Engaged senior leadership AbbVie Company Confidential

26 AbbVie Fermentation Your Preferred Partner 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 AbbVie Company Confidential

27 AbbVie Contract Manufacturing 1401 Sheridan Road North Chicago, IL USA USA: Outside USA: