Production of recombinant proteins for use as pharmaceuticals, so-called biopharmaceuticals, is a multi-billion dollar industry. Many different cell factories are used for the production of biopharmaceuticals, but the yeast Saccharomyces cerevisiae is an important cell factory as it is used for production of several large volume products. Insulin and insulin analogs are by far the dominating bi...

Mammalian cell expression has become the dominant recombinant protein production system for clinical applications because of its capacity for post-translational modification and human protein-like molecular structure assembly. While expression and production have been fully developed and Chinese hamster ovary cells are used for the majority of products both on the market and in clinical develop...

mammalian expression systems, due to their capacity in post-translational modification, are preferred systems for biopharmaceutical protein production. several recombinant protein systems have been introduced to the market, most of which are under clinical development. in spite of significant improvements such as cell line engineering, introducing novel expression methods, gene silencing and pr...

A group of the DECHEMA working “Single-Use Technology in Biopharmaceutical Manufacture” is investigating potential use single-use systems for cellular agricultural applications. The preliminary results are summarized this article.

2015 Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals. These studies are a key component of risk mitigation to reduce the potential for iatrogenic transmission of pathogenic viruses. This paper reviews regulatory guidance and practical strategies for designing viral clearance studies. Essential elements of a developmental pha...