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Master Class: Process Development and Scale-Up in the Pharmaceutical Industry

Master Class: Process Development and Scale-Up in the Pharmaceutical Industry. Module CH510 17 and 18 June 2014. School of Chemistry. Process Development and Scale-Up in the Pharmaceutical Industry.

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Master Class: Process Development and Scale-Up in the Pharmaceutical Industry

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  1. Master Class: Process Development and Scale-Up in the Pharmaceutical Industry • Module CH510 17 and 18 June 2014 School of Chemistry

  2. Process Development and Scale-Up in the Pharmaceutical Industry • As part of their structured PhD programme, NUI Galway’s School of Chemistry, in association with SSPC in UL, are providing a 2-day course on the development and scale-up of organic syntheses for the commercial manufacture of drug substances. The course will • Focus on synthetic processes for “small molecule” drugs and address the organic, physical and analytical chemistry involved. • Cover process selection and development, technology transfer and on-going optimisation with reference to the safety, environmental, engineering, quality and regulatory disciplines involved. • Use real examples to illustrate the subject. • The course will be delivered by • Industrial practitioners • Is aimed at: • PhD students in chemistry and related disciplines. • There will be a fee of €100 for non-NUIG attendees. • Applications to dennis.smith@nuigalway.ie (087-6775481) Dillon Theatre, School of Chemistry 17 and 18 June 2014

  3. Process Development and Scale-Up in the Pharmaceutical Industry • On completion of the course, students will: • Understand the considerations involved in designing a chemical process suitable for industrial manufacturing • Appreciate the scientific disciplines involved in bringing a chemical process from laboratory to industrial scale • Be familiar with the organic chemistry involved in the manufacture of some significant current drugs • Be able to rationalise and discuss the mechanisms of organic reactions involved in the synthesis of drugs • Appreciate the importance of the physical properties of APIs and understand approaches and techniques for their control • ECTS Credits: • 5 (on successful completion of assigned course work) Dillon Theatre, School of Chemistry 17 and 18 June 2014

  4. Process Development and Scale-Up in the Pharmaceutical Industry • Tuesday 17 June • Session 1 Chair Prof Paul V. Murphy (Head of School of Chemistry, NUIG) • 09.00 Registration • 09.15 Welcome & Introduction Prof Paul V. Murphy (NUIG) • 09.30 Process Research and Development. Part 1. Peter J. Harrington (University of Denver) • Synthesis of Lipitor • 10.30 Break Tea and coffee (Concourse) • 11.00 Process Research and Development. Part 2. Peter J. Harrington • 12.00 Technology Transfer to Manufacturing Facility John O’Callaghan (Roche) • Scope and requirements of technology transfer • 12.45 Lunch Soup and sandwiches (An Bhialann) Dillon Theatre, School of Chemistry 17 and 18 June 2014

  5. Process Development and Scale-Up in the Pharmaceutical Industry • Tuesday 17 June • Session 2 Chair Dr Fawaz Aldabbagh (NUI Galway) • 13.30 Quality Assurance Clare Desbonnet (Roche) • Regulatory obligations • Process validation • 14.30 Analytical Controls Patricia Clancy (Roche) • Specifications and test methods for drug substances • In-process controls and process analytical technology (PAT) • 15.30 Break Tea and coffee (Concourse) • 16.00 Chemical Engineering Aspects Eoin Cleary (Roche) • Selection and sizing of equipment • Process flow and process “fits” • 17.00 Process safety management Bill Fleming (Fleming Professional) • Risk identification • Quantified risk assessment • 18.00 Close Dillon Theatre, School of Chemistry 17 and 18 June 2014

  6. Process Development and Scale-Up in the Pharmaceutical Industry • Wednesday 18 June • Session 3Chair Dr Niall Geraghty (NUI Galway) • 9.00 Safety Testing Michael Kennedy (SPDS Ltd) • Chemical reaction hazard assessment • Dust and electrostatic hazard assessment • Vent sizing • 10.00 Environmental Management Seamus O’Grady (Roche) • Licence requirements (ELVs) • Waste minimisation • 11.00 Break Tea and coffee (Concourse) • 11.30 Process Optimisation at the Manufacturing Facility Dennis Smith (NUIG) • Approaches to on-going development • Case study - Mycophenolate Mofetil • 12.30 Lunch Soup and sandwiches (An Bhialann) Dillon Theatre, School of Chemistry 17 and 18 June 2014

  7. Process Development and Scale-Up in the Pharmaceutical Industry • Wednesday 18 June • Session 4 Prof Kieran Hodnett (UL/SSPC) • 13.30 Solid State Properties of APIs Denise Croker (UL) • Critical properties and test methods • 14.15 Solid state properties and manufacturing John Collins (UL/SSPC) • The impact of solid state properties on operations • Operational technologies for control of solid state properties • 15.15 Break Tea and coffee (Concourse) • 15.30 Crystallisation and control of solid state properties Mark Barrett (APC/SSPC) • 16.30 Case studies of process and product quality improvements arising from • crystallisation optimisation John O’Reilly (Roche) • 17.30 Close Dillon Theatre, School of Chemistry 17 and 18 June 2014

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