Introduction The identification and graphical representation of process design space are
critical in locating not only feasible but also optimum operating variable ranges and design …

This case study outlines an application of quality by design principles to a drug substance
manufacturing process. A hybrid process chemistry model consisting of mechanistic and …

Methodologies to determine the Design Space of a pharmaceutical product, within which
continuous improvement can be implemented and postapproval changes in material …

To find the design space (DS) of a pharmaceutical process, quantification of the “assurance
of quality” for the product under development is required. In this study, latent‐variable …

To increase manufacturing flexibility and system understanding in pharmaceutical
development, the FDA launched the quality by design (QbD) initiative. Within QbD, the …

Feasibility analysis is a mathematical technique that can be used to assist the identification
of the design space (DS) of a pharmaceutical process, given the availability of a process …

The design space (DS) is defined as the combination of materials and process conditions
which provides assurance of quality for a pharmaceutical product (eg purity, potency …

The Process Analytical Technology initiative and Quality by Design paradigm have led to
changes in the guidelines and views of how to develop drug manufacturing processes. On …

As one of the most influential industries in public health and the global economy, the
pharmaceutical industry is facing multiple challenges in drug research, development and …

The design of biopharmaceutical processes is predominantly driven by the domain of
experimental process design. This approach can be further improved by combining multiple …