Despite it introducing inefficiencies, increasing risks and delaying regulatory approval, extractables and leachables (E&L) are still frequently tested in isolation from stability studies. However, integrating E&L testing directly into stability programmes offers a proactive route to de-risk development, accelerates timelines and better satisfies global regulators.
Speciality chemical biomanufacturing is entering a pivotal phase, driven by advances in synthetic biology and the urgent demand for more sustainable production. Cell-free platforms decouple biological synthesis from the constraints of living cells, enabling higher tolerance to toxicity and more precise control over reaction conditions.
The global supply chain is no stranger to disruption, but the compounding effects of the current geopolitical situation in the Middle East have exposed profound vulnerabilities in how we manufacture and distribute essential goods.