Now showing items 1-10 of 39
An investigation into the leaching of volatiles from a container closure system into ophthalmic solutions
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 ...
The effects of laser welding on biodegradable materials
A Review of recently Approved Orphan Designation Biological Drugs /
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 ...
Plethora of Potential Platforms: a review of current and future trends in expression system choice in the biopharmaceutical industry /
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 ...
A Structured Analysis of the Novel Technologies used to alleviate bottlenecks in Biopharmaceutical Manufacturing /
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 ...
An in vitro investigation of the antitumour efficacy of novel hybrids containing artemisinin, porphyrin, or naphthalimide derivatives /
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 ...
An analysis of medical device registration and market access in China /
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 ...
Investigation into the challenges encountered by regulatory affairs professionals working in the Medtech industry /
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 ...