Associate Director, Drug Product Development GSK Collegeville, Pennsylvania
Process analytical technology (PAT) is a mechanism to design, analyze and control the manufacturing through real time measurements of quality and performance attributes of materials and processes. It is an important component of a Quality by Design (QbD) framework. In this presentation, we will discuss the importance of PAT during development, scale-up and manufacturing of steriles drug product. We will share the applications of PAT solutions at different stages of product manufacturing and their advantages. We will then focus on 3 specific industrial case studies and share advances in PAT tools and their applications for 3 process steps involved during the product development and manufacturing. 1) First case study will discuss the possible ways of real time monitoring of mixing and dissolution of a soluble API during its compounding step. With focus on spectroscopic techniques (Raman, UV/Vis, NIR, others) based PAT tools, coupled with chemometrics modelling, this work will recommend technologies suitable for integration into the manufacturing process for mixing and dissolution monitoring, and the end point detection. 2) Second case study will cover the applications of spectroscopic techniques (Raman, NIR) along with chemometrics for the real time monitoring and determination of mixing end point for pharmaceutical suspensions. 3) Third case study will discuss the recently available laser diffraction, dynamic light scattering and spectroscopy-based PAT tools for real time particle size measurement during the manufacturing of nano and micro suspensions. These 3 case studies will demonstrate the capability of PAT to a) enable the development and deployment of the robust processes, b) provide greater and faster understanding of the process and its scale-up, and c) evaluate final product critical quality attribute real time with a minimum/no perturbation in comparison to the traditional offline analysis. The presentation will finally cover the challenges of PAT deployment at current state (including business drivers, regulatory aspects) and the vision for the future development for the Pharmaceutical Industry.
Learning Objectives:
Understand applications of PAT tools at different stages of steriles drug product manufacturing and their advantages.
Experience 3 industrial case studies discussing the use of PAT tools in 3 different stages of steriles drug product development.
Acknowledge challenges of PAT deployment at current state (including business drivers, regulatory aspects) and the vision for the future development for the Pharmaceutical Industry.
