At CPHI 2026, Testo will showcase digital solutions for monitoring, compliance, and supply chain transparency in the pharmaceutical industry.
Manufacturers are facing a new generation of nitrosamine challenges as NDSRIs demand more sophisticated analytical and risk management strategies.
How can cell and gene therapy manufacturers move programmes forward faster without compromising quality, scalability or regulatory readiness?
Following his opening keynote at this year’s Advanced Therapies Europe conference in Barcelona, Professor Jacob George, MHRA Chief Medical & Scientific Officer, explores the evolving regulatory landscape for advanced therapy medicinal products.
As biologic drug formats grow more sophisticated, scalable success depends on embedding manufacturability, analytics and quality thinking into molecular design from the very beginning of development.
At CPHI 2026, Testo will showcase digital solutions for monitoring, compliance, and supply chain transparency in the pharmaceutical industry.
Following her presentation at Advanced Therapies Europe, Charlotte Serra navigates the complexities of decentralised cell therapy manufacturing.
Target protein degraders offer therapeutic potential, yet their high potency, poor solubility and ultra-low administered doses place significant demands on formulation science, analytical capability, containment and scalable manufacture. Successful development requires solubility enhancement, particle engineering, excipient design, high-potency containment and process development to be considered together from the earliest programme stages.
Manufacturers are facing a new generation of nitrosamine challenges as NDSRIs demand more sophisticated analytical and risk management strategies.
As patent cliffs threaten hundreds of billions in drug revenues and M&A activity reshapes the industry, the companies best placed to capitalise on pharma’s great reshuffling will be those that have standardised their manufacturing operations, unified their asset management and integrated quality systems capable of satisfying an increasingly demanding multi-regulator environment.
Pharmaceutical and chemical manufacturing facilities present some of the most demanding lighting challenges in industry, combining explosive atmospheres, stringent hygiene requirements and complex regulatory requirements. Raytec examines how explosion-protected LED solutions are redefining safety, performance and compliance across hazardous area applications.
Pharmaceutical quality control laboratories face growing pressure to strengthen data integrity as regulators scrutinise incomplete records, manual data entry, and disconnected systems.
As biotherapeutic manufacturing accelerates, rapid PCR-based methods are enabling manufacturers to detect mycoplasma contamination sooner. However, realising their full potential requires robust validation, risk-based implementation and integration with a wider contamination-control strategy.
A hybrid model built into commercial software and running a self-driving bioreactor has found that unmeasured cellular waste, not the usual metabolites, throttles perfusion yields.
EPR’s 2026 nitrosamines report covers the key developments in manufacturing, quality, regulation, analytical development and beyond.
Tim Sandle explores the main factors that influence particle accumulation in pharmaceutical cleanrooms, advising how best to control risks and minimise operator contamination.
The definitive guide to transitioning from manual, offline batch testing to automated, continuous biomanufacturing.
Cam-driven technology optimises the compaction process by maintaining consistent tablet hardness across turret speeds, enabling robust, scalable manufacturing of capping-prone blends.
Europe’s first dedicated framework for artificial intelligence in GMP manufacturing is close to finalisation and it is more demanding and more consequential than many manufacturers may currently appreciate.
A technical deep dive from Thermo Fisher Scientific reveals how closed-loop Raman spectroscopy is delivering measurable gains in mAb titer, product quality and downstream efficiency—while enabling fully autonomous perfusion processes running continuously for 19 days.