Expert Forum - PAT for API and Biotech, Switzerland

Attended by clients from leading multi-national pharmaceutical companies, discussion focused on critical considerations including data integration, process validation and new methodologies for control parameters.

PM Group experts Keith Morris, Smart Manufacturing and Bryan Humphreys, PAT Specialist, led the forum. Local indepth market knowledge was provided by our Swiss team - Angela D’Urso, Head of Engineering; Roberto Viggiano, Head of CQV and Fergal O’Neill, Operations Manager.

“Design development is a process embracing quality. Regulatory awareness at this early project stage is now critical. To understand the changing environment, open discussion and knowledge-sharing in forums like these is so important.

We are already planning our next Expert Forum on Simulation in May 2024 and will share more on that soon.”

Angela D’Urso, Head of Engineering, Switzerland.

The discussion included many aspects and benefits of PAT, such as:

• Use of PAT in process development, from scale-up to commercial manufacturing.
• How PAT gives process owners the ability to deliver accurate inline/online measurements of critical process parameters (e.g. crystallizations)
• Developing an understanding in through online data interpretation of these measurements.
• Using PAT data to predict and control the process at critical process steps
• How PAT can help ensure product quality while reducing processing cost and cycle times
• How PAT facilitates fast and effective decision making

About PM Group's Expert Forum

The objective of our Expert Forum is to create a technical community to discuss in an open environment, key areas for design development and support around regulatory processes.