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

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Dillon Theatre, School of Chemistry

NUI Galway

Galway

Ireland

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Description

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. (Collected as cash or cheque on registration.)

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)

Directions:

http://www.nuigalway.ie/about-us/contact-us/how-to-find-us.html


Itinerary / Course outline

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)

Session 2

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

Session 3

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)

Session 4

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

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Date and Time

Location

Dillon Theatre, School of Chemistry

NUI Galway

Galway

Ireland

View Map

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