Chapter 23: Case Study for the Implementation and Utilization of a Technology Platform for Sterile-Grade Filtration

Abstract

Sterile-grade filtration is a key unit operation during processing of biotherapeutics. However, selecting the optimal filter type and configuration could be a challenging task. Here we present a case study of a systematic risk-based approach for establishing a sterile filtration technology platform following Quality by Design. Since a technology platform can be considered an ideal form of prior knowledge, it is discussed how it can be leveraged to justify a reduced product-specific testing for future molecules.