METTLER TOLEDO
 

Process Analytical Technology (PAT): The “Official” Language of Pharmaceutical Outsourcing

The application of Process Analytical Technology (PAT) to improve pharmaceutical outsourcing communication is discussed.
English

Case studies presented include: 

  • Drug Product Manufacturing - Real-time batch control of high-shear wet granulation using in-process particle monitoring
  • Process Safety - Standardized thermal analysis using reaction calorimetry to ensure safe process scale-up
  • Active Pharmaceutical Ingredient (API) Manufacturing - In situ reaction monitoring to ensure batch consistency between outsourcing partners
  • Crystallization - Using Process Analytical Technology (PAT) monitoring of batch crystallization to simplify tech transfer between sites
Preview the On-Demand Webinar


Process Analytical Technology (PAT) is a communication tool that can reduce miscommunication that occurs during the transfer of a process to a partner for further development or manufacturing.  Effective PAT provides quantitative measurements of the critical process variables that directly relate to batch success or failure.  By monitoring the batch process in real-time, operators can better ensure that desired batch results are achieved - faster, more repeatable, and with tighter product quality.

As they implement Quality by Design (QbD) guidelines, pharmaceutical companies are becoming more dependent on PAT tools to improve internal communication throughout chemical and product development and manufacturing.  PAT-related data is proving an effective language with which to document and communicate process guidelines and ensure product requirements - between sites and across borders.

As bio-pharmaceutical outsourcing suppliers search for ways to differentiate themselves and improve the efficiency of their own operations, the ability to communicate with the sponsor company in the language of standard PAT methods may prove to be a valuable next step.

Webinar Presenter
Your online presenter, Terry Paul Redman, has over 12 years of experience helping pharmaceutical companies and their partners successfully implement PAT technologies for improved understanding and direct control of critical process parameters in a variety of processes including API synthesis, crystallization, and product formulations.