Traditionally, vaccine manufacture has accounted for a huge amount of aseptic production. In recent years, there has been a larger focus on novel biologic therapies, of which the majority are ...

Currently, bioprocess monitoring and control systems rely on infrequent and time-consuming offline sampling methods. This can lead to loopholes in data and major gaps in knowledge, as well as ...

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This article outlines improvements and changes to non‐viable particle monitoring (NVP), sometimes referred to as total particulate monitoring, which during aseptic processing, is a regulatory ...

Editor’s note: This article is the third in a series to help practitioners learn about the AICPA’s new quality management standards and prepare to implement them. The new final standards on quality ...

Efficiently and effectively producing a biotherapeutic depends on monitoring the bioprocess, but that’s not easy. Although samples can be drawn from a bioreactor and analyzed offline, that can be ...

Monitoring total organic carbon (TOC) (i.e., organics monitoring) is an excellent method for ensuring your industrial processes are under control and your equipment is protected. The goal is to ...