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

While machine learning (ML) has made significant contributions to the biopharmaceutical
field, its applications are still in the early stages in terms of providing direct support for quality …

The biopharmaceutical industries are continuously faced with the pressure to reduce the
development costs and accelerate development time scales. The traditional approach of …

The biopharmaceutical market has experienced a tremendous growth in the last years.
However, this growth should be balanced considering the difficulty in bioproduct …

In a decade when Industry 4.0 and quality by design are major technology drivers of
biopharma, automated and adaptive process monitoring and control are inevitable …

In process engineering, two paradigms of modeling approaches exist: the mechanistic and
the data-driven approaches with the former being completely based on knowledge while the …

Despite the advent of many new therapies, therapeutic monoclonal antibodies remain a
prominent biologics product, with a market value of billions of dollars annually. A variety of …

Continuous processing has been garnering much interest lately for production of
biopharmaceutical products. Purported benefits include higher productivity (10-15X) …

This paper reviews the key building blocks needed to develop a mechanistic model for use
as an operational production tool. The Chinese Hamster Ovary (CHO) cell, one of the most …

Highlights•RS establishes itself as a leading technology for monitoring and control of
CPPs.•The technology shows promise in measuring cell type and differentiation of …