There are numerous opportunities to improve the efficiency of the manufacture and formulation of APIs with the resultant improvement in profitability. In making changes to the process it is unfortunately fairly easy to create a product that will not formulate correctly and therefore does not have the required efficacy.

An understanding of process engineering and the basic unit operations used to manufacture and formulate APIs allows us to carry out a scientific risk assessment and to understand the design space that a process exists within and thereby make us of the Quality by Design approach.

This masterclass will use a number of case studies based on actual process developments and the problems that arose. It also examines areas where basic process engineering principles can be used to define the design space of a pharmaceutical process. It will raise issues that are relevant to all managers, scientists and engineers involved in pharmaceutical and biopharmaceutical development, scale-up and industrialisation processes.

Delegates will be given practical tools and guidance for advancing their business success.