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 ...

The process monitoring market is set to grow from $5.51 billion to $13.30 billion by 2032. With regulators raising expectations around in-process controls, real-time monitoring, and lifecycle ...

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 ...

A fundamental component of modern electronic goods is the semiconductor. More powerful, faster and smaller processors are in constant demand for many services and goods because of the advent of the ...