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Pharmaceutical and biotech companies together offer life-changing or, more appropriately, life-saving medicines and materials containing medicines for patients across the world. To ensure demand is met and patients’ health is not compromised, it is essential a strong and secure supply chain is in place to support the drug development lifecycle.…
The Merck v. Shionogi case of 2017 laid the groundwork for further establishing compulsory licensing as a strategic tool in Germany, particularly in pharma patent litigation. A recent decision in a proceeding brought by Sanofi now provides more guidance on the threshold for obtaining such a compulsory license. This article…
Active pharmaceutical ingredients (APIs) have been established in the pharmaceutical industry over the course of many years. Containment technologies – ie, those strategies developed to contain the APIs – and qualification practices based on API powder containment have primarily been based on health and safety issues related to operator exposure…
The pharmaceutical industry has increasingly voiced its concerns about the possibility of a no-deal Brexit and its impact on supplies and access to medicines. Here, the European Medicines Agency (EMA) gives some last-minute advice to pharma companies ahead of March 2019.
High-throughput mass spectrometry (MS)-based proteomics approaches have developed enormously in recent years and are continuing to do so. The current trend sees proteomics being used by academia and industry to tackle intricate biological questions, often in conjunction with other high-throughput “omics” disciplines such as genomics, transcriptomics and metabolomics. Within the…
Andrew Meyers has travelled across many countries designing, auditing, investigating and correcting failures in temperature supply chains. In this article he explores some examples of his observations from the field.
This In-Depth Focus looks at safe, child resistant and sustainable packaging, and examines the supply chain of temperature controlled packaging.
For decades, near-infrared (NIR) spectroscopy has been an invaluable tool within the laboratory and, interestingly, despite all the excellent instrumentation and technologies introduced for process control, NIR is still the most popular and mature technique available. This article will discuss the impact of NIR in pharmaceuticals from the perspective of…
Strong regimentation and economic interests demand the development and implementation of new techniques for process control and analysis in the pharmaceutical industry. The extensive analysis of all deployed materials, intermediates and products leads to a higher degree of process stability and can contribute to a faster compensation for deviations, especially…
Child safety, and specifically protection from poisoning, is a crucial factor in medicine packaging. In this article, Stephen Wilkins, Chairman of the Child-Safe Packaging Group, discusses the standards that govern child-safe packaging, as well as the importance of ‘ease of opening’ for elderly adults...
NIR technology has been used in the pharmaceutical industry for nearly two decades, but the major driver for its use over the last 10 years was recommendations made by the FDA and other regulating authorities.
In this issue: identification of peptides and proteins in suspected illegal medicinal products using MALDI-TOF-MS, and open data policies in proteomics.
Matrix-assisted laser desorption/ionisation (MALDI) time-of-flight (TOF) mass spectrometry (MS) has proven to be an excellent technique for identification of illegally distributed peptides and proteins for human use. The identification of proteins is mainly based on peptide mass fingerprinting (PMF) – ie, the bottom-up approach – while the small proteins and…
This near-infrared spectroscopy In-Depth Focus looks at online drying process control of pharmaceutical intermediates and how NIR has moved on from the lab.
In this edition of our 'Guide to' series we look at analytical testing instruments from SUEZ.
