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

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Roberta Hicks
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1 Master Class: Process Development and Scale-Up in the Pharmaceutical Industry Module CH510 School of Chemistry 21 and 22 April 2016

2 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 ( )

3 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)

4 Thursday 21 April Session 1 Chair Prof Paul V. Murphy (Head of School of Chemistry, NUIG) Registration Welcome & Introduction Prof Paul V. Murphy (NUIG) Process Research and Development. Part 1. Peter J. Harrington (University of Denver) Synthesis of Lipitor Break Tea and coffee (Concourse) Process Research and Development. Part 2. Peter J. Harrington Technology Transfer to Manufacturing Facility John O Callaghan (Roche) Scope and requirements of technology transfer Lunch Soup and sandwiches (An Bhialann)

5 Thursday 21 April Session 2 Chair Dr Fawaz Aldabbagh (NUIG) Quality Assurance Clare Desbonnet (Roche) Regulatory obligations Process validation Analytical Controls Patricia Clancy (Roche) Specifications and test methods for drug substances In-process controls and process analytical technology (PAT) Break Tea and coffee (Concourse) Chemical Engineering Aspects Eileen Ashall (Roche) Selection and sizing of equipment Process flow and process fits Process safety management Bill Fleming (Fleming Professional) Risk identification Quantified risk assessment Close

6 Friday 22 April Session 3 Chair Dr Patrick O Leary (NUIG) 9.00 Safety Testing Michael Kennedy (SPDS Ltd) Chemical reaction hazard assessment Dust and electrostatic hazard assessment Vent sizing Environmental Management Seamus O Grady (Roche) Licence requirements (ELVs) Waste minimisation Break Tea and coffee (Concourse) Process Optimisation at the Manufacturing Facility Dennis Smith (NUIG) Approaches to on-going development Case study - Mycophenolate Mofetil Lunch Soup and sandwiches (An Bhialann)

7 Friday 22 April Session 4 Chair Prof Kieran Hodnett (UL/SSPC) Solid State Properties of APIs Denise Croker (UL) Critical properties and test methods Solid state properties and manufacturing John Collins (GSK) The impact of solid state properties on operations Operational technologies for control of solid state properties Break Tea and coffee (Concourse) Crystallisation and control of solid state properties Mark Barrett (APC) Case studies of process and product quality improvements arising from crystallisation optimisation John O Reilly (Roche) Close

ORGANIC PROCESS RESEARCH & DEVELOPMENT JUNE Toronto, Canada. The Leading Process Chemistry Conference and Exhibition

ORGANIC PROCESS RESEARCH & DEVELOPMENT JUNE Toronto, Canada. The Leading Process Chemistry Conference and Exhibition Invoice (if different to delegate address) PROCESS RESEARCH 17-19 June 2019, Alphora Research Inc, 17-19 June 2019, Visit, email, +44 1435 873062 Invoice (if different to delegate address) 17-19 June 2019,