The global coronavirus pandemic continues to restrict public life worldwide. An effective
means of limiting the pandemic is vaccination. Messenger ribonucleic acid (mRNA) vaccines …

Despite great efforts to develop a vaccine against human immunodeficiency virus (HIV),
which causes AIDS if untreated, no approved HIV vaccine is available to date. A promising …

The development and adoption of digital twins (DT) for Quality-by-Design (QbD)-based
processes with flexible operating points within a proven acceptable range (PAR) and …

Population balance models (PBM) have been widely used to model the twin-screw wet
granulation (TSWG) in the continuous manufacturing of solid dosage forms. However, some …

Quality-by-Design (QbD) is demanded by regulatory authorities in biopharmaceutical
production. Within the QbD frame advanced process control (APC), facilitated through …

This in-depth study looks into how artificial intelligence (AI) could be used to make
formulation development easier in fluidized bed processes (FBP). FBP is complex and …

Population balance models (PBMs) have been widely studied for the simulation of
continuous twin-screw wet granulation. Due to the limited data availability and …

Continuous powder mixing offers many advantages over batch processes, but its industrial
implementation requires control of transient phases due to startup or variations in operating …

Purpose Powder feeding is a vital unit operation in the continuous manufacturing of
pharmaceutical products. Loss-in-weight twin-screw feeders are commonly used in …

This chapter presents a design framework and associated new assessment tools for solid
drug product manufacturing processes. The framework describes the design flow in the form …