1. Master Class: Process Development and Scale-Up in the Pharmaceutical Industry
Module CH 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 ( )
Dillon Theatre, School of Chemistry 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 and 18 June 2014

4. 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
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)
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
Lunch Soup and sandwiches (An Bhialann)
Dillon Theatre, School of Chemistry and 18 June 2014

5. 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 and 18 June 2014

6. 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 and 18 June 2014

7. 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 and 18 June 2014