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Issue #3 2016 – Digital edition
In this issue: Biosimilars, Regulation, Packaging, Microfluidics, Microbiology, PAT, Antibiotic Resistance, and much more...
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Issue 3 2016
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Microbiology: In-Depth Focus 2016
In this Microbiology In-Depth Focus: Risk-based microbiological testing; Improving microbiological assurance for bioburden testing; Microbiology Roundtable...
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Pharmaceutical Packaging In-Depth Focus 2016
In this Pharmaceutical Packaging In-Depth Focus: End-to-end verification of the medicines supply chain; Understanding the financial implications of the upcoming falsified medicines regulations; Point of view on the evolution of labelling and packaging.
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Biosimilars – future prospects
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…
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Regulatory Insight: Pharma sector – long a target for antitrust enforcers
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…
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Microfluidics in cell-to-cell signalling measurements
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…
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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…
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Antibiotics resistance Q&A
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…
