Brian Davies

Quality by design and PAT approaches are increasingly being used for the biotech manufacturing of medicines. Complex manufacturing processes can not only be controlled using PAT principles, but optimized with respect to both product quality and economic value. This column describes how the fermentation process is often the first to benefit from this type of implementation.

The PAT market is developing and evolving rapidly as pharmaceutical firms strive to implement the framework set in place by the regulators. As with all new markets, people will engage at different times, at differing rates, and for different reasons. This editorial seeks to treat PAT in classical marketing terms, describing four phases of the PAT market evolution and discussing how the PAT market will likely mature.

Measuring, understanding and ultimately controlling manufacturing processes offers pharmaceutical companies a route to greatly enhance the business effectiveness of both their product development process and facilities. PAT creates technological, business process and regulatory frameworks to enable this. This paper looks at a PAT overview within the context of developing and manufacturing a tablet product, highlighting the potential of FT-NIR spectroscopy.

A look at how process analytical technology promises to be the most radical change in pharmaceutical manufacturing in 30 years...