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 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

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

Dillon Theatre, School of Chemistry 17 and 18 June 2014 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

Dillon Theatre, School of Chemistry 17 and 18 June 2014 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

Dillon Theatre, School of Chemistry 17 and 18 June 2014 Process Development and Scale-Up in the Pharmaceutical Industry Wednesday 18 June Session 3 Chair 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

Dillon Theatre, School of Chemistry 17 and 18 June 2014 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