演讲题目
生物药物生产车间污染控制的案例研究

Michael Ahern

爱尔兰都柏林理工大学 计算科学系主任

Professor Mike Ahern was educated in University College Cork, Ireland and received a Bachelor of Science (honours) degree in Chemistry. He graduated with a PhD in Physical Chemistry which was awarded in 1986. Mike continued his academic studies and received a Diploma in Business Management from Trinity College Dublin in 1989 and a research Masters in Engineering in 1991 from Dublin City University.

He was employed after completing his PhD as a postdoc in a joint project with Philips (The Netherlands) and Siemens (Germany) investigating the engineering properties of electro chromic and photo chromic materials produced by a low temperature reactive magnetron sputtering process.

For a period of nearly three years he worked with the Ceramics Department of the Irish Institute for Research and Standards to establish a physical vapour deposition research and testing base. This department was instrumental in developing the Programme for Advanced Technology (PAT) in Advanced Materials and in assisting Irish companies develop applied research for product improvement purposes. Later Mike worked in a manufacturing company as a formulation chemist and was involved in a number of scale-up projects in Ireland and in the USA.
He joined The Technological University of Dublin (formerly the Institute of Technology Tallaght) as the Head of Department of Science in 1992 and has worked in the capacity of Academic Registrar and is currently the Dean of the Faculty of Science & Computing.

Mike has worked with the large pharmaceutical and biopharmaceutical companies in Ireland over the last number of years. His specialisation is in workforce development and he has had a number of EU projects in this area. He has also interests in formulation science, problem solving and good manufacturing practice.

Abstract
In the biotechnology manufacturing sector the key aspects of aseptic manufacture, contamination control and monitoring together with satisfactory problem resolution are at the forefront of today’s highly regulated biologics industry.

This presentation will address the issue of CAPA (Corrective and Preventive Actions) arising from a Case Study of a persistent bacterial contamination problem in a leading biopharmaceutical manufacturing plant.

A broad outline of the manufacturing process will be presented. Initially the Case Study will recount the efforts made in understanding the source of the contamination and the reasons underpinning the persistent nature of the contamination. The tools employed in this phase of the investigation will also be featured in the discussion. Additionally the series of Corrective Actions (short term actions) that arose will be presented. Finally the nature of the longer term Preventive Actions will be addressed.

The Preventive Actions have resonances both in the medium and long term for a biopharmaceutical manufacturing plant.

The role played by the Technological University of Dublin (Tallaght Campus) in every aspect of the Case Study will be highlighted.