Easier access to information, targeting smaller patient populations, and increased regulatory focus on patient outcomes are driving patient-centric drug development. / read more /
Proactive approaches that consider long-term supply chain security compliance are recommended to ensure companies stay on the right track. / read more /
FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards. / read more /
Although continuous approaches offer significant benefits for some products and processes, batch manufacturing is not going away any time soon. / read more /
The editors explore novel technologies for the formulation, manufacture,
purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.