In this study, two separate methods were developed and validated for two different products to track three leachables; cyclohexanone, propylene glycol monoethyl ether acetate (PGMEEA), and propylene glycol monomethyl ether ...

No abstract

Orphan Drugs are a critical resource for those suffering from rare diseases and there is an urgent need for many new drugs to address the thousands of serious rare conditions which affect millions of people across the ...

In the thirty years since the first biopharmaceuticals were approved for use in humans, the choice of expression system for new biopharmaceuticals has remained largely unchanged and is still mainly determined by the necessity ...

Biopharmaceutical companies are under increasing pressure to meet the market demand from patients. Despite a high growth sector within the life sciences sector, the same types of manufacturing methods have been employed ...

Novel hybrid drugs have emerged as a promising new anticancer strategy. A hybrid drug is a compound in which two active ‘parent’ drugs are linked to create a single molecular entity with a multimodal action. The main ...

The focus of this research is in the area of medical device registration and market access in China. Such a study is important as China is one of the largest markets for medical devices in the world making it an important ...

This research focused on the challenges experienced by Regulatory Affairs professionals working in the Medtech industry. Initial brainstorming with regulatory colleagues who have greater than ten years’ experience identified ...