Spectroscopy In-Depth Focus 2016
In this Spectroscopy In-Depth Focus: The benefits of NIRS in monitoring and controlling a crystallisation process; Pharmaceutical applications of terahertz spectroscopy and imaging; and much more...
List view / Grid view
Articles
Approaches in subcutaneous delivery of monoclonal antibodies
Currently, subcutaneous delivery of therapeutic proteins is a fast-growing field, especially for such established modalities as monoclonal antibodies, which require large quantities of drug to be administrated. Different approaches, including high protein concentration, speciality formulations and drug delivery matrices, as well as devices enabling a more rapid administration of larger…
Current activities of the USP general chapters
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
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
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...
Celltrion Healthcare on Remsima and biosimilars
With Remsima being on the market for a year, European Pharmaceutical Review caught up with Celltrion Healthcare to find out more about biosimilars...
Exploring the need for mutation-specific treatments in cystic fibrosis
1 July 2016 | By Caroline Richards, Editor, European Pharmaceutical Review
Here, Caroline Richards, Editor of European Pharmaceutical Review, discusses cystic fibrosis and the treatment options that are currently available or in development...
Issue #3 2016 – Digital edition
In this issue: Biosimilars, Regulation, Packaging, Microfluidics, Microbiology, PAT, Antibiotic Resistance, and much more...
Microbiology: In-Depth Focus 2016
In this Microbiology In-Depth Focus: Risk-based microbiological testing; Improving microbiological assurance for bioburden testing; Microbiology Roundtable...
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.
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…
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…
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…
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…
