The development and application of emerging technologies of Industry 4.0 enable the
realization of digital twins (DT), which facilitates the transformation of the manufacturing …

Abstract Process Analytical Technology (PAT) instruments include analyzers capable of
measuring physical and chemical process parameters and key attributes with the goal of …

Biopharmaceuticals have revolutionized the field of medicine in the types of active
ingredient molecules and treatable indications. Adoption of Quality by Design and Process …

The growing biopharmaceutical industry has reached a level of maturity that allows for the
monitoring of numerous key variables for both process characterization and outcome …

This manuscript provides an in-depth review of the significance of quality control in herbal
medication products, focusing on its role in maintaining efficiency and safety. With a …

Biotherapeutic products, particularly complex products such as monoclonal antibodies
(mAbs), have as many as 20–30 critical quality attributes (CQAs), thereby requiring a …

There is a need for sensing technologies that can continuously monitor concentration levels
of critical biomolecules in applications such as patient care, fundamental biological …

Among the greatest challenges in soft sensor development for bioprocesses are variable
process lengths, multiple process phases, and erroneous model inputs due to sensor faults …

Biopharmaceutical production has recently begun transitioning toward the construction of
highly advanced, digitalised production facilities, as per Industry Revolution 4.0 or smart …

Today's biomanufacturing processes are still operated based on experience, and thus can
hardly cope with increasing bioprocess complexity. Recently, there is a growing interest in …