The growing complexity and regulatory rigour of combination products has called for increasingly innovative delivery devices. This article looks at the advantages of using an integrated system for these drug-device combination products rather than sourcing components from different suppliers.
Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology they concurrently evaluate whether or not to manufacture the therapies onsite. Here is a guideline of how and when to get started.
Critical quality attributes are fundamental to regulatory compliance in drug development and manufacturing. Learn how surface plasmon resonance has been applied for protein characterization of antibody effector function.
Rocking bioreactor systems can shorten the seed train prior to inoculation and provide optimized growth conditions for sensitive cells. This study presents a robust production of adenovirus using such a system.