Bioproduction (part of CPHI) 2022

Join us for the following session, and learn more about our technologies first hand with Pall Experts. Take the opportunity to meet us on booth 91H35 Hall 9.1.

Tuesday  November 1, 2022 @ 12:30 CET

Manufacturing Strategy Stream

Process Intensification – from Antibodies to Viral Vectors

Abstract

"Over the past decade, various companies have started the implementation of continuous and connected process technologies in cGMP manufacturing. Most implementations of continuous production technologies target enhanced manufacturing efficiencies for monoclonal antibodies.

In this presentation, we will review the drivers for process intensification and how different manufacturing environments may require different solutions. For this purpose, a more holistic perspective on process intensification is chosen. This includes the primary process flow consisting of a series of (connected or disconnected) unit operations. The second and third dimension along which the drivers for process intensification are reviewed are the supply of materials and buffers and data management. The fourth aspect that will be addressed is sometimes referred to as process portability, which involves scale-up from bench to clinical and commercial manufacturing and technology transfer between various manufacturing sites.

We will review solutions to address all aspects of process intensification within the context of a monoclonal antibody manufacturing platform. In addition to this, we will discuss how process intensification has helped bringing a viral vector-based vaccine to market in very short time. During process development and organization of technology transfer, many choices were made to reduce “muda” and accelerate development, scale up and technology transfer to a network of manufacturing sites across the globe.”