Master Class: Process Development and Scale-Up in the Pharmaceutical Industry Module CH510 26 and 27 April 2018 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” active drug ingredients (APIs) 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 26 and 27 April 2018

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 26 and 27 April 2018

Process Development and Scale-Up in the Pharmaceutical Industry Thursday 26 April Session 1 Chair Patrick O’Leary (Head of School of Chemistry, NUIG) 08.30 Registration 09.15 Welcome & Introduction Patrick O’Leary (NUIG) 09.30 Process Research and Development. Part 1. Peter J. Harrington (University of Colorado at Boulder) 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 Greg Donegan (Roche) Scope and requirements of technology transfer 12.45 Lunch Soup and sandwiches (College Bar) Dillon Theatre, School of Chemistry 26 and 27 April 2018

Dillon Theatre, School of Chemistry 26 and 27 April 2018 Process Development and Scale-Up in the Pharmaceutical Industry Thursday 26 April Session 2 Chair TBA 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 Eileen Ashall (Boston Scientific) 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 26 and 27 April 2018

Process Development and Scale-Up in the Pharmaceutical Industry Friday 27 April Session 3 Chair TBA 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 (College Bar) Dillon Theatre, School of Chemistry 26 and 27 April 2018

Process Development and Scale-Up in the Pharmaceutical Industry Friday 27 April Session 4 Chair TBA 13.30 Solid State Properties of APIs Denise Croker (UL) Critical properties and test methods 14.15 Crystallisation and control of solid state properties Brian O’Sullivan (APC) 15.15 Break Tea and coffee (Concourse) 15.30 Case studies of process and product quality improvements arising from crystallisation optimisation John O’Reilly (NUIG) 16.30 Continuous processes for manufacture of APIs Colm O’Mahony (Eli Lilly) 17.30 Close Dillon Theatre, School of Chemistry 26 and 27 April 2018