This work presents a bird's eye view depicting current trends in the pharmaceutical industry
and the role of mathematical modeling in process design and operation within the …

This manuscript discusses the role of process systems engineering (PSE) in ensuring quality
manufacturing of Mesenchymal Stem Cells (MSCs) through seeding, cultivation, and …

This paper provides an overview of concepts and computational approaches for the
evaluation of feasibility/flexibility and how they can be used for process design and process …

Continuous manufacturing of small molecules finds increasing application in developing
novel processes due to its significant advantages. The development of these processes is …

Current seeding processes of mesenchymal stem cells (MSC) in 2D in vitro culture systems
rely on the experience and practice of experimentalists. A systematic understanding of the …

Human-induced pluripotent stem cell (hiPSC)-derived cardiomyocytes have potential
applications in regenerative medicine. The quality by design (QbD) approach enables the …

The authors have developed and improved a mathematical model that de-scribes the impact
of errors in determining the structure of the approximating function on the results of the …

Implementation of the design space (DS) is a scientific concept for ensuring quality to be
submitted as a part of the regulatory filing of a drug product for approval to market. An …

This work presents an image‐based hybrid model incorporating the initial spatial distribution
for mesenchymal stem cell (MSC) cultivation process design. First, three levels of seeding …

Introduction Preparing a uniform cell population in high–density seeding of adherent human
induced pluripotent stem cells (hiPSC) requires stable culture conditions and consistent …