Biopharmaceutical developers should introduce risk-based, phase-appropriate characterization strategies for quality control ...

Early-phase clinical trials are undergoing a quiet but consequential transformation. Once considered a relatively narrow checkpoint focused on basic safety and tolerability, these early-phase studies ...

This Brush Up is sponsored by MilliporeSigma. Learn more about therapeutic synthesis pathways. Drug development is a process that spans many years, from the initial phase of identifying potential drug ...

As resources become less accessible – both in terms of funding and personnel - smaller or emerging sponsors are unlikely to have a large Chemistry, Manufacturing and Controls (CMC) group. In fact, in ...

Conducting product development in formalized stages provides direction, minimizes waste and increases the chances that the product will be well-received by the market. We endorse an approach that ...

Value stream management involves people in the organization to examine workflows and other processes to ensure they are deriving the maximum value from their efforts while eliminating waste — of ...