Gsk Plc · LSE:GSK
Gsk — GlaxoSmithKline — Technical Presentation (November 2010)
46 slides from Gsk's technical presentation, November 2010
Slide 1: GlaxoSmithKline Cork – Capacity & Capability
GlaxoSmithKline Cork – Capacity & Capability November 2010
Slide 2: GSK Cork Presentation Contents
GSK Cork Presentation Contents Section 1 • Site Role • Facilities Overview • Key Strengths & Capabilities Section 2 • Available Manufacturing Facilities & Capacity • Pilot Plant and Milling Facilities Section 3 • New Product Introduction Capability • Operational Excellence Capability • Supporting Te
Slide 3: GSK Cork Presentation Contents
GSK Cork Presentation Contents Section 1 • Site Role • Facilities Overview • Key Strengths & Capabilities
Slide 4: GSK Cork - Background
GSK Cork - Background Operations commenced 1975 Site role within GSK: New Product Introduction & Global Supply • Clinical supplies and scale up in co-located R&D Pilot Plant • Industrialisation of New Products to provide supplies for validation and launch and to develop the final most cost effective
Slide 5: do more, feel better, live longer
do more feel better live longer
Slide 6: Land in Use at GSK Cork – 70 acres
Land in Use at GSK Cork – 70 acres
Slide 7: Land Available at GSK Cork – 85 acres
Land Available at GSK Cork – 85 acres
Slide 8: Facilities at GSK Cork – 155 acres
7 Production buildings 269,297 Litres capacity 19 Modules 61 reactors (30-16,000 Litres) 23 isolation devices OHC 2-5 containment Facilities at GSK Cork – 155 acres
Slide 9: Central Milling Facility
Central milling facility (OHC3-10µg/m3) Module 1: Air Classifier Mill (100ZPS) Module 2: High Speed Hammer Mill Module 3: Wet Bead Milling / Spraydrying Facility Central Milling Facility
Slide 10: R&D Pilot Plant
Building 9 R&D Pilot Plant R&D Pilot Plant
Slide 11: Environmental Facilities
Environmental Facilities Waste water treatment Incinerators & one thermal oxidiser VOC Abatement / Scrubbing System Solvent and waste storage Solvent recovery plants Chemical treatment Waste heat to steam generation plant Environmental Facilities
Slide 12: Utilities
Utilities Full range of steam (from incinerator heat recovery), hot water, cooling water, brine Single fluid heat transfer system in new plants Purified water plants. On site Nitrogen generators 20 kV electrical supply Utilities
Slide 13: Other Facilities
Other facilities Quality Control & development laboratories Research & Development Lab Physical Properties Lab Offices / locker rooms Cafeteria Meeting Rooms Document Archive Other Facilities
Slide 14: GSK Cork – Key Strengths and Capabilities
GSK Cork – Key Strengths and Capabilities Compliance • 12 FDA Inspections, 11 with zero findings on form 483 • Strong audit compliance with Environmental Protection Agency and Health & Safety Authority Integrated R&D/Product Transfers • Co-location of R&D Pilot Plant - 7 yrs of Phase 2/3 manufacture
Slide 15: GSK Cork – Employees
GSK Cork – Employees Total Number of employees: • GSK Cork Site employees: 367 • Technical Shared Service employees based at Cork: 40 • R&D Cork employees: 32 • Others (above site, universities, etc): 24 Qualifications*: • PhD/Masters degree ~ 56 • BSc/3rd level ~ 130 • Process Operators/Crafts ~ 18
Slide 16: GSK Cork Presentation Contents
GSK Cork Presentation Contents Section 2 • Available Manufacturing Facilities & Capacity • Pilot Plant and Milling Facilities • Slides 18 to 37 give a summary of the facilities that could be made available for external / sharing business. These facilities are backed up by significant technical capab
Slide 17: API & Intermediate Plant - Building 3 Module 2
API & Intermediate Plant - Building 3 Module 2 • A large scale multipurpose processing plant for API’s and Intermediate stages • Built in 2007 at a cost of €70M Building 3 Module 2 • Highly flexible processing module – API or Intermediate finishing areas • 1 Glass Lined and 1 Hastelloy reactor vesse
Slide 18: API & Intermediate Plant - Building 3 Module 2 Processing Equipment
API & Intermediate Plant - Building 3 Module 2 Processing Equipment Solids Charging Room (Visual Contained M 3rd Plant Room Charging System) WHTK 1 (Combivac Vacuum Pumps/ 1000L Bulk Solvent Manifold Nitrogen Recirculation System) 316L SS Dedicated Purified Water Generation Plant Building 3 [Located
Slide 19: API & Intermediate Plant - Building 2
API & Intermediate Plant - Building 2 • A medium/large scale multipurpose processing plant for API’s and Intermediate stages Building 2 • Highly flexible processing module – API and Intermediate finishing areas • 4 Glass Lined and 3 Hastelloy reactor vessels • 1,500L to 7,500L scale of wet end proce
Slide 20: API and Intermediate Plant Building 2 Processing Equipment
API and Intermediate Plant Building 2 Processing Equipment Roof Vent Manifolding to Scrubber / Incinerator Bulk Solvent Manifold HTK-1 M 250L 2nd GLCS Building 2 RV-2 8000L M RV-1 GLCS 6300L M Lasentec HC22 or PTS Turbidity Temp Loop GB-1 316L FDR-1 FDR-2 1st HTK-2 RV-3 6300L RV-4 6300L RV-5 4500L 3
Slide 21: API or Intermediate Plant - Building 7
API or Intermediate Plant - Building 7 Building 7 • A medium scale multipurpose processing plant for API and Intermediate stages • 2 Glass Lined reactor vessels • 1000L to 4000L scale of wet end processing • 1 Stainless Steel Filter Dryer (1.5m2) • 1 glovebox for contained charging • 1 glovebox for
Slide 22: API or Intermediate Plant – Building 7 Processing Equipment
API or Intermediate Plant – Building 7 Processing Equipment 2nd Floor Vent Manifolding to Incinerator HTK-12 1300L M GLCS GB-2 316L Sampling G’Box RV-1 GB-1 Building 7 RV-2 316L Solvent Manifold: 4000L 7000L IMS; THF; EtAc; GLCS GLCS M M Toluene; Acetone; Methanol; Process Water 1st Floor FDR-1 1,5
Slide 23: Intermediate Plant - Building 6
Intermediate Plant - Building 6 • A medium to large scale multipurpose processing plant for Building 6 Intermediate stages • 4 Glass Lined reactor vessels • 2,000L to 8,000L scale of wet end processing • 1 Hastelloy Filter Dryer (3m2) and 1 Stainless Steel Filter Dryer (3m2) • 2 gloveboxes for conta
Slide 24: Intermediate Plant – Building 6 Processing Equipment
Intermediate Plant – Building 6 Processing Equipment 2nd Floor HTK-3 1600L HTK-4 M GLCS M 600L 316L SS HTK-1 Building 6 M 2165L 316L SS HTK-2 GB-1 M 450L 316L GB-2 316L Vent Manifolding to Incinerator GLCS FDR-1 FDR-2 1st Floor 3.0 m2 3.0 m2 Wiped Filter-1 Film RV-1 RV-2 HC22 316L SS M 1.6m2 RV-3 Ev
Slide 25: Intermediate Plant - Building 1 Module 33
Intermediate Plant - Building 1 Module 33 Building 1 Module 33 • A medium/large scale multipurpose processing plant for Intermediates stages • 1 Glass Lined and 1 Hastelloy reactor vessels • 1,500L to 6,000L scale of wet end processing • Can operate with module 32 or as a stand alone module • 1 Stai
Slide 26: Intermediate Plant - Building 1 Module 33 Processing Equipment
Intermediate Plant - Building 1 Module 33 Processing Equipment Venting available to HCL Scrubber & FDR1 incinerator 3m2 HTK1 1000L 316L M GLCS Building 1 Bulk Solvents: Module 33 Third floor RV1 M 6300L GLCS Second Discharge Area floor Drum Charging booth HTK2 RV2 500L M 6300L 316 SS Hast C22 First
Slide 27: Intermediate Plant - Building 1 Module 3
Intermediate Plant - Building 1 Module 3 Building 1 Module 3 • A medium/large scale multipurpose processing plant for intermediate stages, currently used for GSK products with up to 50% capacity available • 4 Glass Lined and 2 Hastelloy reactor vessels • 1,000L to 6,300L scale of wet end processing
Slide 28: Intermediate Plant - Building 1 Module 3 Processing Equipment
Intermediate Plant - Building 1 Module 3 Processing Equipment 2nd Venting to Incinerator HTK1 HTK 2 RV 1 HTK3 RV2 Bulk Solvent Manifold 250L 2500L 4000L 2500L 6300L Building 1 GLCS GLCS GLCS GLCS GLCS Module 3 FDR1 Turbidity 2 X Charge booths 6.0 m2 M M M M 2X PTS Charge Booths 316L SS 316L SS Mass
Slide 29: Small Scale High Containment Plant - Building 5
Small Scale High Containment Plant - Building 5 Building 5 • A small scale multipurpose processing plant for API’s and Intermediate stages • OHC 5 (< 1 g/m3) capability and highly flexible processing module • 6 Gloveboxes • Dedicated development & QC analytical laboratory • 2 Glass Lined and 1 Haste
Slide 30: Small Scale High Containment Plant - Building 5 Processing Equipment
Small Scale High Containment Plant - Building 5 Processing Equipment 3 x Gloveboxes and 2 x fumehoods GMP QC Analytical Lab Dispensing + Utilities area Solvent Charging fumehood (pressure kettles) Area Development Lab Building 5 Vent to Inert Header via HEPA filter GB-1 316L SS Upper Level 1 x gaf G
Slide 31: Summary of Pilot Plant & Milling Facilities Available
Summary of Pilot Plant & Milling Facilities Available
Slide 32: R&D Pilot Plant
R&D Pilot Plant • Contains 2 modules with up to 2,500 Litre reactors • Highly flexible for multiple chemistries– can introduce products within 4 weeks and at less than €50-100K capex • Suitable for introducing new products to the site, scale up/development and clinical supplies • Flexible quality sy
Slide 33: Proof Copy Only
Proof Copy Only Not For Use 22.06.04
Slide 34: Dry Milling Suite
Dry Milling Suite • Meets GMP standards for final milling and handling of API (class 100,000) • Segregated suite with 3 Floors • Air Classifier Mill (316L SS) and final kegging/packaging through a glovebox • Suitable for products with exposure limits to 10 micrograms/m3
Slide 35: Dry Milling Suite Processing Equipment
Dry Milling Suite Processing Equipment
Slide 36: Wet Bead Milling / Spraydrying Suite
Wet Bead Milling / Spraydrying Suite • Segregated suite suitable for wet bead milling and spraydrying of API and excipients • Patented GSK Technology • 3 Floors • 11 Wet Bead Mills • Spray drier (316L SS PSD3 NIRO) • Capacity of 15 - 20MT API equivalent per annum
Slide 37: GSK Cork Presentation Contents
GSK Cork Presentation Contents Section 3 • New Product Introduction Capability • Operational Excellence Capability • Supporting Technology & Physical Properties Laboratory Capability
Slide 38: New Product Introduction Capability
New Product Introduction Capability •Very strong record for introduction of new products – Experienced technical staff •Co-located R&D Pilot Plant – Clinical Manufacture for phase 2/3 and validation to support launch – Highly flexible facility, suitable for process development and scale up •Flexible
Slide 39: Operational Excellence Capability
Operational Excellence Capability • Master Blackbelt: 2 • Blackbelt Certified: 3 • Blackbelts in training: 4 • Greenbelt Trained: 94 – Certified: 62 • Advocate* Trained: >220 – Certified: 180 *3 levels • OE builds smarter, simpler and sustainable processes and ways of working • OE reduces variation,
Slide 40: Supporting Technology
Supporting Technology • The plant is highly automated with Delta V batch software control. For some processes the eBR system is used to generate an Electronic Batch Report. • Sophisticated temperature control • The production plant is designed for quick changeover between products by allowing each v
Slide 41: Physical Properties Laboratory Capability
Physical Properties Laboratory Capability Cork have a range of techniques that can be used to assess: • Physical nature of the material – Optical Microscopy – Scanning Electron Microscopy (SEM) – X-Ray Diffraction – Tap Bulk Density (TBD) – Particle size measurement (Malvern and Sympatec instruments
Slide 42: Laboratories
Laboratories Quality Test Laboratory Physical Property Laboratory •Classic wet chemistry techniques •PSA – Particle size analysis (Malvern •TLC Mastersizer S, 2000 and Sympatec Helos) •Melting Point •SEM – Scanning electron microscopy (LEO EVO 40XVP) •FT-IR, ATR •XRPD – X-ray powder diffraction (PAN
Slide 43: Other Laboratory Facilities
Other Laboratory Facilities • Chemistry – Jacketed vessels – Multimax (facilitating DOE) – Hydrogenation facilities • Engineering – 0.03m2 filter-dryer – 10Lt and 15Lt jacketed vessels – Solvent recovery rig – Facility to wheel equipment in for trials
Slide 44: GSK Cork Presentation Contents
GSK Cork Presentation Contents Section 4 • Environmental & Solvent Recovery Capability
Slide 45: Environmental Operations
Environmental Operations • There is an extensive environmental operation on site. • The following activities are carried out: – High temperature Incineration (2 Plants) with surplus capacity – Waste Water Biological Treatment – Chemical Treatment – Solvent Recovery( see next slide) – Storage of liqu
Slide 46: Solvent Recovery
Solvent Recovery • There are two large solvent recovery plants on site (1 Multi Purpose Unit & 1 Batch Recovery Unit) with extensive spare capacity. • These units are fully automated. • Solvents (e.g. Toluene, IPA, Methanol, Ethyl Acetate, Acetone, Heptane, Methylene Dichloride) have been recovered
GlaxoSmithKline — Technical Presentation (November 2010) on 6ix