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Current activities of the USP general chapters

24 August 2016 | By

From a microbiological perspective, pharmaceutical products fall into two categories – nonsterile and sterile. For both categories manufacturers must eliminate, or minimise, potential health risks to patients related to microorganisms and the toxins they produce, whilst maintaining product quality. Many contributing factors may affect the quality of a medicine or…

Application of LCMS in small-molecule drug development

24 August 2016 | By , ,

As a technology, mass spectrometry (MS) has evolved to the point where it is used throughout the drug development process. In particular, when MS is coupled with high-performance liquid chromatography (HPLC) it adds an orthogonal detection function for sample analysis and provides unique capabilities for pharmaceutical analysis, such as sensitivity,…

Characterising therapeutic antibodies and ADCs using mass spectrometry

24 August 2016 | By

Since the 1970s, the advent of biotechnology has resulted in the development and commercialisation of many therapeutic proteins, including antibodies and antibody fragments, for the treatment of human diseases. Examples include antibody treatments for autoimmune diseases (for example, adalimumab [Humira®] for rheumatoid arthritis), cancers (such as trastuzumab [Herceptin®] for breast…

Hepatitis C: commitment to a cure

28 July 2016 | By Niamh Louise Marriott, Digital Content Producer

To find out more about Hepititis C, European Pharmaceutical Review spoke with Raquel Peck, CEO of the World Hepatitis Alliance and discovered exactly what it is being done to combat this widespread global health issue...

Biosimilars – future prospects

30 June 2016 | By

Biologically-derived drugs, such as proteins, peptides and monoclonal antibodies (mABs), are playing an increasingly important role in global healthcare. It was recently reported that mAB therapeutics sell for over $50 billion globally. However, one of the major downsides of biological therapeutics is their significantly greater costs compared with small molecule…

Regulatory Insight: Pharma sector – long a target for antitrust enforcers

30 June 2016 | By ,

Many features of the pharmaceutical sector make it prone to antitrust scrutiny. Intellectual property rights, in particular patents, and the promise of monopoly rents while patents remain valid, play a crucial role in incentivising new product research and development. On the other hand, the European Commission and the various national…

Microfluidics in cell-to-cell signalling measurements

30 June 2016 | By ,

Hormones are secreted molecules that carry biological information between cells. This type of cell-to-cell communication is vital to human life, and its dysregulation often underlies disease. In fact, the largest known class of cell surface receptors involved in hormone communication, G-protein coupled receptors, are also the largest class of known…

PAT Series: Recent achievements in NIR-based on-line monitoring of lyophilisation processes

30 June 2016 | By Adrian Funke - Bayer Pharma AG / Reinhard Gross, Stephan Tosch and Albert Tulke - Bayer Technology GmbH

Process analytical technology (PAT), namely near-infrared (NIR) and Raman spectroscopy, has already been shown to be a useful tool for monitoring, analysing and optimising the complex process of lyophilisation. The latter process is especially challenging in the case of biopharmaceutical formulations due to the instability of active ingredients, leading to…

Antibiotics resistance Q&A

30 June 2016 | By

With the rise in drug-resistant bacterial infections heralding a new, dark era of medicine, antibiotics alternatives could one day become the first-line defence against infectious diseases. With the urgent need to find new approaches clear, Caroline Richards, Editor of European Pharmaceutical Review, interviewed Dr. Bjorn Herpers, Chief Medical Advisor of…

EU Referendum: Tell us what you think…

20 June 2016 | By Caroline Richards, Editor, European Pharmaceutical Review

With only days to go until Britain holds a referendum on its EU membership, we can't help but wonder how you feel...