Scale-up is one of the toughest challenges facing today’s pharmaceutical and biopharmaceutical manufacturers with industry trends indicating a rapid increase in the number of new biologicals and new potent compounds.

These developments, and others, are fueling an increased demand for scalable processes, information sharing and additional regulatory insight early in product development.There is a need scientifically and economically within the industry to share understandings of variable drivers and design space effecting scale-up instead of treating expensive and time consuming trial and error discovery as a trade secret.

The SWE Successful Process Scale-up for Pharmaceutical and Biologics Development Conference is a roadmap of information regarding experiences in choosing tools, technologies and advanced regulatory methods for optimization of scale-up. This includes, transdermal products, oral controlled release, lyophilized parenteral products, pre-mixed solutions and more.