A cascade of high-profile drug recalls and evolving FDA and EMA guidance have pushed nitrosamine risk assessment from a late-stage afterthought to an early-development priority
Aurion Biotech's manufacturing approach to unmodified allogeneic corneal endothelial cells offers a set of hard-won lessons for a cell therapy field still working out how to get from proof-of-concept to broad patient access.
The Synthetic Molecule Process Innovation Phorum brings together major pharma companies, regulators, and CDMOs to build consensus on pressing challenges in small molecule manufacturing.
The field's foundational biology is no longer the limiting factor. What comes next depends on whether the industry can build the manufacturing, commercial, and clinical infrastructure to match what the science already knows how to do.