The manufacturing process for cell and gene therapies is complex and can contain process-related impurities from multiple organisms. A commercial host cell protein (HCP)-ELISA kit is often not ...

Mass spectrometry (MS) is increasingly popular among drug makers keen to ensure that process impurities do not impact the safety or efficacy of their products. The method is used to measure the ...

Pharmaceutical companies encounter numerous challenges during drug development as they strive to demonstrate a product's safety and efficacy. Image Credit: DSI, a PLG Company To achieve this, ...

This white paper discusses developing optimal platform analytical methods with partner CDMOs for effective process impurities clearance in biological drug substances. Get the essential updates shaping ...

Protheragen, an ISO9001 certified supplier of pharmaceutical ingredients and specialty chemicals, announces its expanded suite of end-to-end impurity solutions covering impurity synthesis & isolation, ...

Having intelligent analytical tools can advance the detection of unknown impurities, which is important for ensuring small-molecule ingredient purity. The United States Pharmacopeia (USP) defines an ...

Biotechnology start-ups are often advised to think early about process design to avoid hiccups during scaleup. A clinical-stage gene-therapy developer has taken this approach to heart, saying they’ve ...