E&L and stability studies
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.
Biomanufacturing specialities
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.
Navigating supply chain volatility
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.
Comment: Methane pyrolysis
Historically, methane pyrolysis has been a field dominated by startups and small and medium-sized enterprises (SMEs). Monolith is the most commercially advanced company, while other notable players, such as Hazer Group, Modern Hydrogen and Graphitic Energy, are emerging across various pyrolysis pathways.
Persistent infrastructure identity
Picture the qualification closeout of a new API manufacturing suite or specialty chemical production unit. Years of engineering and compliance work have produced process hazard analyses, P&ID validation packages, equipment qualification protocols, containment integrity test records, and regulatory submission dossiers. That documentation is the most complete technical and regulatory portrait the facility will ever have. The process keeps running. Its compliance memory does not.
Comment: Creating a quality culture
To operate successfully in a Good Manufacturing Practice (GMP) regulated contract testing environment, an organisation needs more than documented procedures and validated systems. Sustained compliance depends on the culture that surrounds those systems and shapes how people apply them every day.
Comment: Turquoise hydrogen
Blue and green hydrogen often dominate the conversation of low-carbon hydrogen. Meanwhile, turquoise hydrogen, sitting between blue and green, is quietly gaining momentum. This raises key questions: what is turquoise hydrogen, how mature are its technologies, and how close is it to commercial deployment?
Comment: Evolving purchasing priorities
Over the last decade, business procurement has evolved significantly. Previously focused on achieving the best outcome in terms of performance and cost, procurement is now an increasingly strategic corporate function, with any new purchase needing to aid business performance and meet increasingly stringent compliance, sustainability and governance targets. Recent developments in AI and data processing are accelerating this evolution.
Comment: Particles and EU Law
Let’s talk about… dust – fine particles that are carried in the air – and how it is or should be regulated under European Union rules. Putting dust together with legal considerations is not the most obvious flex but we can simplify it to this: on the assumption that dust gets into our lungs, does it cause an adverse effect such the EU regulator needs to step in?
Comment: Global medicine use
Increasing usage of medicines, and the associated amount being spent, have become central issues in health policy and international trade discussions in recent years, including the potential reshaping of global markets and drug pricing that is being proposed by the US administration.