As blockbusters fade and biologicals or personalised medicines come to the fore, traditional high volume facilities are being replaced by small scale, flexible plants and single-use technologies. Susan Birks reviews the year’s process trends, equipment and analytical tools.
The production facilities of the pharmaceutical world are changing at a faster pace than ever before. This is in part due to the rapid discoveries and progress being made in biotechnology and stem cell technology but also to increasing regulatory and health authority demands for better performing, more sustainable and consistent products. As a result, we are seeing increased use of PAT and Quality by Design (QbD) principles as demanded by the regulators. There is also the ever more critical need to drive down costs.