PAT - Articles and news items

PAT supplement (free to view)

Latest issue, Supplements / 15 December 2011 / Terry McMahon (PAI Partners), Dr. Marianna Machin, Dr. Lorenz Liesum, Dr. Antonio Peinado (Novartis Pharma AG), Ravindra Dhumal, Tim Gough (Centre for Pharmaceutical Engineering Science, University of Bradford)

The historical development of the FDA’s PAT initiative and its present course (Terry McMahon, PAI Partners)

Implementation of modelling approaches in the QbD framework: Examples from the Novartis experience (Dr. Marianna Machin, Dr. Lorenz Liesum and Dr. Antonio Peinado, Novartis Pharma AG)

Challenges in development and implementation of spectroscopic techniques as PAT Analysers (Ravindra Dhumal and Tim Gough, Centre for Pharmaceutical Engineering Science, University of Bradford) (more…)

PAT & QbD Supplement (free to view)

Issue 3 2011 / 20 June 2011 / Magida Zeaiter - GlaxoSmithKline, Mark Morton - Phoenix Scientific Services, Joachim Ermer - Head of Quality Control Services Frankfurt Chemistry - Sanofi

Featuring articles: “A basis for innovation and continuous improvement of process understanding and control in pharmaceutical product development” by Magida Zeaiter, GlaxoSmithKline, “Flexible processing assures product quality” by Mark Morton, Phoenix Scientific Services and “Quality by design: A lifecycle concept for pharmaceutical analysis” by Joachim Ermer, Head of Quality Control Services Frankfurt Chemistry, Sanofi. (more…)

Market leaders Expo Technologies, Umetrics provide better PAT tool connectivity

Featured news, News / 18 April 2011 / Expo Technologies LLC

Expo Technologies (St. Louis, MO) and Umetrics Inc. (San Jose, CA), industry leaders in providing tools for Pharma PAT, announce the release of Expo’s NovaMath 5.0 with capability to use models built in SIMCA- P+ by the SIMCA-QP tool. This capability allows process measurement devices controlled by Expo’s NovaPAC/NovaMath applications to run Umetrics’ SIMCA- P+ models, in real time.

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Applying PAT in pharmaceutical processes

Issue 5 2010 / 1 November 2010 / Mario Hellings, Tom Van den Kerkhof, Jeroen Geens and Steve Mehrman, Johnson & Johnson

As cited by the FDA, “Process Analytical Technology (PAT) is a system for designing, analysing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.”1 The main goal of PAT is to gain a deep understanding of manufacturing processes and to learn how to control them1. When processes are understood, opportunities for continuous improvement (quality and efficiency), cycle time reduction, cost reduction and QC lab test replacement arise. In this article, the strategy of Johnson & Johnson Pharmaceutical Research & Development (J&J PRD) towards the implementation of PAT in Pharmaceutical Process Development is explained and elucidated by case studies. (more…)

Process Analytical Technology: An industry perspective

Issue 4 2010 / 19 August 2010 / Uwe Kirschner, General Manager, Sentronic GmbH, Rick E. Cooley, Market Development Manager - Process Analytics, Dionex Corporation, Rebecca Vangenechten, Business Development, Siemens Headquarters Pharma and Kjell François, Project Leader in PAT

Process Analytical Technology (PAT) is a system for designing, analysing and controlling pharmaceutical manufacturing processes through measurements of critical quality and performance attributes of raw and processed materials to ensure final product quality, the idea of which is to become more efficient while reducing over-processing, enhancing efficiency and minimising waste. In this roundtable, three leading pharmaceutical PAT companies offer their opinions on why PAT is becoming more and more essential to the pharmaceutical industry. (more…)

Article 3: The implementation of rapid microbiological methods

Issue 3 2010, Past issues / 24 June 2010 / Michael J. Miller, Ph.D., President, Microbiology Consultants, LLC

This is the third in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method. This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorisation. (more…)

Raman spectroscopy for the analysis of drug products and drug manufacturing processes

Issue 2 2010 / 9 May 2010 / Prof. Thomas De Beer, Assistant-Professor, Process Analytical Technology, Faculty of Pharmaceutical Sciences, University of Ghent

This article aims at supplying a concise overview on the application of Raman spectroscopic analysis methods within the pharmaceutical drug product manufacturing world. Firstly, there will be a focus on the rapid and nondestructive off-line analysis feasibility of Raman spectroscopy for final drug products. Herewith, several possible sources of error will be discussed. Secondly, the applicability of Raman spectroscopy for in-process monitoring of drug product production processes will be highlighted. In addition, the tendency within the pharmaceutical industry to move from batch processing towards continuous manufacturing will be envisaged. (more…)

‘Pharmaceutical Industry / University’ R&D collaboration on Process Analytical Technologies

Issue 2 2010 / 9 May 2010 / Professor Nicolas Abatzoglou, Chair, PAT in Pharmaceutical Engineering, Department of Chemical and Biotechnological Engineering, Université de Sherbrooke

Process analytical technologies (PAT) are mature and well advanced in the classical chemical industry. Many successful industry/university R&D collaborations are aimed at the development of analytical methods and their application in process control. However, PAT in the pharmaceutical industry is a rather new field. It is precisely this latter reality that makes many scientists, scientists-engineers and other practitioners sceptical about the possibility and the usefulness of establishing similar R&D collaborations between industry and academia. (more…)

Contributing to the Sustainability of the UK Chemicals and Pharmaceuticals Industries

Industry Focus 2010, Past issues / 22 February 2010 /

The Centre for Process Analytics and Control Technology (CPACT) is a unique industry-driven multi-disciplinary research and development club that was formed in 1997 by the Departments of Pure and Applied Chemistry at the University of Strathclyde, the Department of Chemical and Process Engineering at the University of Newcastle and the Department of Chemistry at the University of Hull, together with 18 member companies. (more…)

Process Analytical Technology (PAT) in Freeze Drying: Tunable Diode Laser Absorption Spectroscopy as an evolving tool for Cycle Monitoring

Issue 6 2009, Past issues / 12 December 2009 /

The most important critical product parameter during a freeze-drying process is the product temperature at the ice sublimation interface, Tp₁. Once the product temperature in this area of interest exceeds the critical formulation temperature (typically denoted as “collapse temperature”, Tc) during primary drying, a stepwise loss of the cake structure may be observed_2,3. This, in turn, can greatly impact the product quality attributes with regard to product appearance, reconstitution times, sub-visible particles and residual moisture content₄. (more…)

Real-time NIR monitoring of pharmaceutical blending processes with multivariate quantitative models

Issue 5 2009, Past issues / 9 October 2009 /

Process analytical technology (PAT) initiatives are now an integral part of developmental efforts in the pharmaceutical industry. Many technical and scientific papers and even dedicated sections appear regularly in several pharmaceutical manufacturing publications. They may be part of a quality by design (QbD) project to better identify and understand critical process parameters. The need and plus value of PAT is usually well-recognised and understood through establishment of the design space of a unit process. However, monitoring and control methodology and PAT protocols are still undefined, and there is no global consensus yet. It is on these grounds that ASTM started working groups focusing on the elaboration of standards in model building and process monitoring with PAT. (more…)

QbD and PAT: From Science to Compliance

Issue 4 2009, Past issues / 30 July 2009 /

Boards of health like the Food and Drug Administration and European Medicines Agency and ICH guidelines Q8, Q9 and Q10, provide a framework for Quality by Design (QbD) that fully integrates drug substance and drug product development with the principles of Quality Risk Management (QRM), Process Analytical Technology (PAT) and Quality Systems (QS). QbD may begin as early as drug substance engineering and could extend to formulation and process development. (more…)