Lactate production is monitored in industrial processes as a crucial metabolite for cultured
mammalian cells. Typically lactate is strongly produced during the exponential growth phase, …

This work investigates the insights and understanding which can be deduced from predictive
process models for the product quality of a monoclonal antibody based on designed high‐…

Quality by Design (QbD) is a new approach to the development of recombinant therapeutic
protein products that promotes a better understanding of the product and its manufacturing …

The manufacturing of recombinant protein is traditionally divided in two main steps:
upstream (cell culture and synthesis of the target protein) and downstream (purification and …

An innovative high-throughput medium development method based on media blending was
successfully used to improve the performance of a Chinese hamster ovary fed-batch …

Rational and high‐throughput optimization of mammalian cell culture media has a great
potential to modulate recombinant protein product quality. We present a process design method …

A host‐cell‐related proteolytic activity was identified in a recombinant Fc‐fusion protein
production process. This report describes the strategy applied to characterize and isolate the …

Clinical efficacy and safety of recombinant proteins are closely associated with their structural
characteristics. The major quality attributes comprise glycosylation, charge variants (…

Integrated continuous manufacturing is entering the biopharmaceutical industry. The main
drivers range from improved economics, manufacturing flexibility, and more consistent …

Mammalian cell perfusion cultures are gaining renewed interest as an alternative to
traditional fed‐batch processes for the production of therapeutic proteins, such as monoclonal …