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The work of a pharmaceutical scientist requires precision, attention to detail and is of vital importance to the safety of products and ultimately patients. This section features insights from experienced scientists who’ve worked extensively in microbiological analysis, developing tests, methods and standards that help establish a foundation for the production…
Emerging recombinant Factor C (rFC) methods have many advantages to offer pharmaceutical quality control, including improved specificity, robustness, efficiency and alignment with 3R principles. First, global manufacturers have validated rFC and pharmacopoeias worldwide are on the move. Here, Karolina Heed provides an industry and regulatory update.
Modernisation of microbiological test methods involves far more than just the science. As new systems and technologies become available it becomes increasingly important that potential users can identify not only the technical requirements, but also the business case. Here, Paul Newby, Alice Laures and Lisa Wysocki from GlaxoSmithKline discuss criteria…
Today’s biopharmaceutical developers need accurate and precise information at all stages of research and development in order to bring safe and effective therapies to patients. This in-depth focus features novel perspectives from industry experts that serve to illustrate which technologies and systems are benefitting this cause.
In this edition of our ‘Guide to’ series, learn how these leading companies’ services and expertise can help you test your pharma/ biopharma products and medical devices.
As today’s scientists continue to identify new biopharmaceutical products with potential to treat a wide array of diseases, formulation remains the determining factor in their success. But what is involved in these increasingly complex formulation processes and how do they impact the packaging and delivery systems?
This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…
With the UK bracing itself for a 'no-deal' Brexit or some other outcome that has not yet been determined, pharma experts discussed the potential effect of Brexit on the supply chain and how to best prepare for it against the upcoming deadline.
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…
Blockchain technologies have the potential to improve transparency, efficiency and reliability of transactions in a heavily regulated pharmaceutical industry. However, there are challenges and limitations. Nikki Withers speaks to Bob Celeste, founder of the Centre for Supply Chain Studies, who has been exploring the potential use of blockchain technology to…
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.
