PAT: In-Depth Focus 2014

• A cultural change is needed for PAT to achieve manufacturing excellence
  Prabir Basu, Pharmaceutical Manufacturing, OPEX and cGMP Consultant and CPhI Panel Member
  Process Analytical Technology (PAT) greatly enhances the drug development process and is a much-needed process advancement to the pharmaceutical industry. CPhI panel member Prabir Basu summarises his thoughts on how PAT can be used to help push forward standards in manufacturing practices. He believes that for PAT to fully achieve its potential, cultural changes are needed across the industry, since on its own, it is just a tool and needs to be used in conjunction with other measures and a wider culture of achieving excellence…
• The role of PAT in biopharmaceuticals production
  João A. Lopes, University of Lisbon
  This article discusses the latest achievements in the implementation of Process Analytical Technology (PAT) to assist in the monitoring of biopharmaceuticals manufacturing processes. Biopharmaceuticals can still currently be considered as a major challenge to the pharmaceutical manufacturer. Their production raises considerable risks associated with robustness and cost effectiveness of supply chains. This couples with the increasing growth of personalised and stratified medicines and even the need to reduce investment capital and production costs. Ensuring PAT systems and related underpinning science are both flexible and performant for biopharmaceuticals production processes is a major challenge…
• PAT Roundtable
  Moderators: Professor David Littlejohn, Department of Pure and Applied Chemistry, Centre for Process Analytics and Control Technology, University of Strathclyde and Professor Julian Morris Technical Director, Centre for Process Analytics and Control Technology
  With contributions from Peter Traynor (Global Sales Lead for Mass Spectrometers, Thermo Fisher), Denise Root (Marketing Manager for NIRSystems at Metrohm USA), Katherine A. Bakeev (Director, Application Support Services, B&W Tek), Alan Hoffmeister (Global Field Technical, Manager, Charles River, Endotoxin and Microbian Detection)