1. Master Class: Process Development and Scale-Up in the Pharmaceutical Industry
Module CH and 27 April 2018
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” 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 ( )
Dillon Theatre, School of Chemistry and 27 April 2018

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 27 April 2018

4. 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
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)
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
Lunch Soup and sandwiches (College Bar)
Dillon Theatre, School of Chemistry and 27 April 2018

5. 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 and 27 April 2018

6. 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 and 27 April 2018

7. 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 and 27 April 2018