The Evolution of PAT for Small Molecules

by | Jun 22, 2021

PAT methods (primary, parallel, reference), managing uncertainly, and Control Strategy (engineering control, pharmaceutical control, recipe control)

Are you looking for quality strategies for your small molecule manufacturing? If so, listen to Martin Warman discuss how process analytical technology (PAT) has developed to ensure the highest standards for pharmaceutical manufacturing.

In the presentation, Prof. Martin Warman will take a closer look at the history of PAT. He will explain the types of PAT methods from primary and parallel to reference methods - what type of methods are each, why should you know about them and what are they used for. Managing uncertainly is a key requirement to PAT and Prof. Warman will go on to discuss the various forms of Control Strategy - engineering control, pharmaceutical control and recipe control. He will also provide a series of case studies from batch-wise direct compression to NIR for monitoring blending unit operation.

By watching this presentation you will learn that:

  • PAT is much more than process analytics
  • PAT methods can have various roles in the Control Strategy used to ensure we stay in a state of control
  • there is uncertainty in our knowledge and we need to manage the risk around this uncertainty

Prof. Martin Warman spent 7 years at Vertex, developing the Vertex continuous manufacturing (CM) platform, on which the first approved CM products are manufactured. He has over 25 years’ experience in the field having previously led the Global PAT Development Team, Pfizer Global Manufacturing. Martin plays an active role in ASTM E55, being the technical lead on standards covering sampling, PAT enabled control systems and continuous manufacturing, is on the ISPE PAT Community of Practice (CoP) global steering committee, and chairs the UK Affiliate PAT CoP. At University of Strathclyde, Martin is an Associate Member of Centre for Process Analytics and Control Technology (CPACT) and supports the CMAC Future Manufacturing Research Hub as well as being the Research Director for the Medicines Manufacturing Innovation Centre (MMIC) being built in Renfrewshire, Scotland, where University of Strathclyde are the Strategic Research partner.

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