Spray Drying: Scale-Up and Manufacturing

Abstract

In this work, Sect. 8.1 describes a scale-up methodology for spray drying processes based on scientific first principles, simulation models, and process characterization techniques. Special attention is given to the selection of right scale of spray dryer for any given processes and product demands, and also to the ancillary equipment. The main concerns and challenges involved in the establishment of an industrial process are discussed and exemplified with real-case examples. Several modeling tools are introduced and their usefulness and relevance in different stages of process development, viz. product and process familiarization, scale-up trials, and process intensification, are exemplified. The benefits of this methodology and of the mechanistic description during process development are also discussed.

Section 8.2 illustrates a case study consisting in the development of a spray-dried dispersion process for a late-stage candidate. The spray drying process was developed under a quality by design (QbD) approach at a large commercial-scale unit. The goal of this section is to highlight some important stages of the methodology (risk assessment, statistical and mechanistic modeling, and design space analysis and verification), emphasizing the benefits and the challenges that can emerge when processes are developed under QbD.