The Food & Drug Administration's recent approval of process analytical technology (PAT) for use in the pharmaceutical industry is being hailed by drug manufacturers because it encourages process ...

In the context of current good manufacturing practice (cGMP), a number of pharmaceutical manufacturers are incorporating Process Analytical Technologies (PAT), Quality by Design (QbD), or Process ...

Expansive growth in the gene and cell therapy (GCT) space has led to developers and manufacturers facing a multitude of challenges on the road to commercialization. To overcome issues associated with ...

Process analytical technology (PAT) has reshaped how biomanufacturers monitor and control production, moving quality assurance from end-of-batch laboratory testing into continuous, real-time ...

Cell therapy developers need purpose-built process monitoring technologies, according to researchers who say better systems would accelerate manufacturing and reduce costs. The conclusion is based on ...

Process analytical technology (PAT) describes the FDA-endorsed framework for measuring and controlling pharmaceutical manufacturing processes through real-time data collection and analysis. The FDA's ...

Business process analysis (BPA) is a methodology that helps organizations deeply examine internal processes to find opportunities for improvement. BPA helps to identify processes that can be made more ...