Mario Hellings - Articles and news items

PAT Supplement 2013

Process Analytical Technology (PAT): In-depth focus 2013

Issue 6 2013, PAT & QbD, Supplements / 16 December 2013 / Morten Allesø, Anette Seo Torstenson, Mette Bryder and Per Holm, Chemical & Pharmaceutical Research (H. Lundbeck A/S), Anneleen Burggraeve, Tom Van den Kerkhof, Jeroen Geens, Lieve Bijnens and Mario Hellings (Johnson & Johnson)

Presenting a rational approach to QbD-based pharmaceutical development: A roller compaction case study
PAT for pharmaceutical spray drying
PAT Roundtable
Show Preview: IFPAC® 2014

Figure 2 Spray drying. Screenshot of on-line PSD analysis, providing real-time PSD-measurement (top-right) and continuous PSD-monitoring (bottom; d50-orange, d90-blue, d10-green, transmission-red)

Applying PAT in pharmaceutical processes

Issue 5 2010, PAT & QbD / 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.

Applying PAT in Chemical Process Development

Issue 3 2009, Past issues / 29 May 2009 /

As the time-to-market of pharmaceutical products has elongated, while its prices are under big pressure, cost saving is currently essential in the pharmaceutical industry.

PAT: not a purpose in itself

Issue 2 2008, Past issues / 19 March 2008 /

The process analytical technology guidelines have been a hotly debated topic within the pharmaceutical industry ever since they were made public in 2004. This also holds true at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), Division of Janssen Pharmaceutical N.V. In recent years, the company has introduced PAT tools in its manufacturing operations and in its development organisation on a project-by-project basis. Several of these projects have resulted in a better insight into critical manufacturing processes and have led to significant optimisations.


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