1 / 7

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.

tadhg
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

More Related