Capability GSK Cork has over 17 years experience in the - - PowerPoint PPT Presentation

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Capability GSK Cork has over 17 years experience in the - - PowerPoint PPT Presentation

DOING BUSINESS IN IRELAND Irelands corporation tax rate of 12.5% is amongst the lowest in the world and compares very favourably with other countries Ireland also has a favourable holding company regime and is an attractive location to


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DOING BUSINESS IN IRELAND

  • Ireland’s corporation tax rate of 12.5% is amongst the lowest in

the world and compares very favourably with other countries

  • Ireland also has a favourable holding company regime and is an

attractive location to establish corporate support / hub activities

  • A 25% tax credit can be claimed for R&D expenditure. Ireland

also has a network of double taxation treaties

  • Government support is available for capital projects, employment

grants and research and development activities

  • Ireland is the only English speaking member of both the EU

and Euro Zone

  • GSK Cork is located 15 minutes from Cork International Airport
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GSK Cork - High Containment Capability

GSK Cork has over 17 years experience in the manufacture of High Containment products. The site had 2 high containment buildings

  • Building 5 is a state of the art small scale facility (commissioned in 2007) designed for the

handling , manufacture and testing of highly potent compounds.

  • Building 8 is a state of the art small to medium facility (commissioned in 1999) designed for the

handling , manufacture and testing of small to medium scale OHC4/OHC5 compounds In addition to our high containment facilities the site has signiicant experience in the maintenance and cleaning of a modern high containment facility. The required Environmental, Health and Safety and Medical Surveillance procedures associated with high containment

  • perations are well deined and familiar to all personnel.

Currently there is free capacity in these facilities to accommodate business development

  • pportunities that exist for the development and manufacture of highly potent products e.g.

cytotoxic materials. GSK Cork is interested in partnering with company’s that require a high containment state of the art facility and expertly trained staff.

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GSK Cork –Technical Transfer Capability

GSK Cork has extensive experience in the introduction of New Chemical Entities (NCE) from R&D Recently Cork has completed 3 business opportunities transfers. The experience from the NCE transfers has enhanced key attributes of a process against previous performance at other sites Some examples of where GSK Cork has added value to customers Yield increase by up to 5% per stage of a process manufactured Throughput increased by 15% by optimising iltration and drying operations Safer plant operation Equivalent or better quality performance Process optimisation through targeted development work

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Small Scale High Containment Plant - Building 5

  • A small scale multipurpose processing plant for API’s and Intermediate stages
  • OHC 5(< 1mg/m

3) capability and highly lexible processing module

  • < 30 nanograms/m3 demonstrated
  • 6 Gloveboxes
  • Dedicated development & QC analytical laboratory
  • 2 Glass Lined and 1 Hastelloy reactor vessels
  • Hydrogenator
  • 5L to 44L scale of wet end processing
  • 1 Hastelloy Filter Dryer
  • Remote manual or batch sequence operation with electronic batch record
  • Batch size 300g to 4.5kg (Process dependant)

Building 5

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Small Scale High Containment Plant - Building 5 Processing Equipment

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FDR-1 0.035 m2 Hast RV-2 44L GLCS HTK-1 25L GLCS Receivers

Dispensing Area

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Hydrogenation manifold

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Drum Charge Stations X 4 Vent to Inert Header via HEPA filter

Upper Level External

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GB-1 316L SS 1 x gaf Duty/Standby filters GB-2 316L SS RV-1 44L Hast C22 GB-3 316L SS 2 x cartridge filters RCV-1 200L GLCS RCV - 2 200L GLCS

Lower Level

GB-4 316L SS Waste Drum Filling Containment System

Utilities area

3 x Gloveboxes and 2 x fumehoods Solvent Charging fumehood (pressure kettles) RV-3 44L GLCS r

GMP QC Analytical Lab + Development Lab

Building 5

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Material Dispensing- BLD 5

Material Charging- BLD 5

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Primary Processing Area- BLD 5 High Containment Laboratory- BLD 5

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Medium Scale High Containment Plant

  • Building 8
  • A small to medium scale multipurpose processing plant for API
  • OHC 5 (< 1mg/m3) containment for charging and offload
  • 4 Glass Lined reactor vessels
  • 20L to 400L scale of wet end processing
  • Dedicated scrubber
  • 1 Hastelloy Filter Dryer (0.3m 2)
  • 1 Solids filter
  • Contained filter Glovebox
  • Dedicated development & QC analytical laboratory
  • Remote manual or batch sequence operation with electronic batch record
  • Batch size 9kg to 40kg (Process dependant)
  • Typical Capacity 1MT to 14MT

(Process dependant)

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Small Scale High Containment Plant - Building 8 Processing Equipment

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Dispensary

RV-1 250L GLCS RV3 400L GLCS RCV2 630L GLCS RCV1 630L GLCS

Ground floor First floor

FDR1 0.22m2 C22

Drum Charging

Venting available to scrubber & incinerator Bulk Solvents:

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RV4 400L GLCS Filter 1 0.3m2 C22 GB4 GB5 GB1 GB2

1st Floor Mezz 2nd Floor

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RV-2 GLCS 250L GB3 (Filters)

Drum Discharger

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HTK3 316L 1275L

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HTK4 316L 1275L

Pressure Kettle Charging

Fume Hood for odorous Charging

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HTK 1 SS PFA Lined 20L

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HTK 2 SS 120L

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Material Dispensing- BLD 5

Material Dispensing- BLD 8 Material Charging- BLD 8

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Primary Processing Area- BLD 8 High Containment Laboratory- BLB 8