SFI CASE STUDY SOILD STATE PHARMACEUTICAL CLUSTER

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SFI CASE STUDYSOILD STATE PHARMACEUTICAL CLUSTER

• B Keaveny
• 23rd June 2009

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Contents

• HCI
• HCI Vision
• SFI and the Solid State Pharmaceutical Cluster
• Industry Support
• SSPC Activities
• Conclusion

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Helsinn Chemicals Ireland Ltd.

• HCI is a modern high-quality API manufacturing
  finishing plant
• Synthesis of small molecule APIs up to 1MT scale.
• HCI is an EU-certified GMP manufacturer of APIs
  and is also registered to supply API to the
  Japanese market.
• Facility covers an area of 8,000 sq. m. on a site
  of 18,500 sq. m.
• HCI benefits from the highly favourable corporate
  tax structures and research grants available in
  Ireland.

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HCIs Value Proposition Unique Primary and
Secondary Manufacturing Capability

• To bridge the DS-DP gap Competitive advantage
• Gain unique expertise in this area, underpinned
  by powder technology
• The traditional disconnect between primary and
  secondary manufacturing leads to operational
  inefficiencies.
• E.g. part-formulate up to tabletting, providing a
  1-stop shop
• Simpler project management and easier technology
  transfer
• Added value for supplier, cheaper for customer
• Faster product to market
• Knowledge of secondary manufacturing facilitates
  the supply of API that is more suited to
  formulation

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SFI and the Solid State Pharmaceutical Cluster

• Solid State Pharmaceutical Cluster (SSPC)
• Funded by Science Foundation Ireland who will
  allocate 1.4B between 2007-2013 to academic
  research teams 
• SSPC secured 5-7M to address industrial solid
  state needs, over a 5 year programme
• Involves vibrant research groups in 5 key
  universities
• Supported by 10 industrial sponsors
• Provides training for industrial supporters,
  basic and applied research (PhDs and post-docs),
  as well as a central forum for addressing solid
  state issues

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Solid State Pharmaceutical Cluster

• Industry sponsors
• Significant flexibility in sponsorship form
• Mixture of cash and in-kind contributions
• HCIs approach is based on
• Supporting PhD student, Chem Eng Dept, UCD
• Specialist project work, School of Pharmacy, TCD
• Helsinn man hours, translated into costs, in
  support of the two projects
• Key issue of IP needs to be fully addressed up
  front

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Solid State Pharmaceutical Cluster

• Solid State Pharmaceutical Cluster (SSPC)
• The three key activities for 2009 in the SSPC
  are
• Establishment of Best Practice in the solid state
  area
• Technical Meetings
• Training

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Solid State Pharmaceutical Cluster

• Establishment of Best Practice in the solid state
  area
• Governed by a steering committee, this initiative
  has a key objective of establishing best practice
  by year end 2009
• Powder Handling Powder charging, movement,
  sampling, packaging and containment.
• Particle Management Sieving, milling,
  de-lumping, micronisation, nanonisation, roll
  compaction and blending.
• Powder Properties Techniques used to understand
  pharma particles at the particulate and bulk
  levels will be assembled, studied and assessed.
• Safety Current industrial standards for managing
  powder safety, encompassing all issues from
  exposure to explosion, will be studied and
  surveyed.
• Storage Acceptable storage systems, set against
  the backdrop of the regulatory requirements for
  product stability, will be assessed

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Solid State Pharmaceutical Cluster

• Technical Meetings
• Meetings take the form of academic and post
  grad/post doc lectures on areas of research, as
  well as Best Practice team updates.
• UCC in Q4 2008 - presentations from software
  companies, to establish the technology for the
  Best Practice web site, as well as initiation of
  the Best Practice programme
• NUIG in Q1 2009 - presentations on
  crystallisation/polymorph case studies, all
  delivered by academic speakers.
• Training
• Three training sessions to date
• Covered solid state fundamentals, from
  crystallisation to pre-formulation.

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Solid State Pharmaceutical Cluster

• Conclusion
• Effective collaboration between academia and
  industry
• Targeted research in key areas
• Strong financial support from SFI
• Significant benefits for participating industry
  sponsors
• Benefits for HCI
• Subsidized and targeted RD programs
• Extends the HCI technology base at minimal cost
• Enhances brand image and reputation