Mycoplasmas (a generic name for Mollicutes) are a predominant bacterial contaminant of
cell culture and cell derived products including viruses. This prokaryote class is …

Acquiring the earliest possible identification of pathogenic microorganisms is critical for
selecting the appropriate antimicrobial therapy in infected patients. We herein report the …

Biopharmaceutical manufacture is transitioning from batch to integrated and continuous
biomanufacturing (ICB). The common framework for most ICB, potentially enables a global …

Animal serum is a common additive for cell culture medium and is often required at 5 to
10%(v/v) for the attachment and growth of primary and continuous anchorage-dependent …

Introduction One of the most challenging safety issues in the manufacture of cell based
medicinal products is the control of microbial risk as cell-based products cannot undergo …

Advanced nucleic acid-based technologies are powerful research tools for novel virus
discovery but need to be standardized for broader applications such as virus detection in …

Using Streptococcus pyogenes as a model, we previously established a stepwise
computational workflow to effectively identify species-specific DNA signatures that could be …

In summary, this chapter reviews the principles of how the current and routine tests detect
adventitious agents, and reviews how novel and emerging methods differ in their detection …

Contamination by viral and microbial agents is a serious risk for biopharmaceuticals
produced by mammalian cell culture processes. In order to effectively mitigate the risk and …

Identifying pathogenic microorganisms as early as possible is critical for selecting the
appropriate antimicrobial therapy in infected patients. We previously reported the …