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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
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Articles
Microbiology In-Depth Focus 2019
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…
Expert View: Advancing bacterial endotoxin testing with recombinant Factor C
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.
It’s not just about the science: microbiological analysis
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…
Biopharma Processing & Development In-Depth Focus 2019
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.
Guide To Testing
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.
Formulation In-Depth Focus 2019
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?
European Pharmaceutical Review Issue 2 2019
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…
Is the pharma sector ready for a ‘no-deal’ Brexit?
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.
Paving the way to a bright future for single-use bioprocessing
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.…
Compulsory licenses in Germany: a tool for licensing negotiations?
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…
Aseptic containment strategies to meet challenges of processing new highly toxic and biologically hazardous sterile medicinal products and therapies
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 potential of blockchain in a regulatory environment
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…
Preparing for a no-deal Brexit
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.
Open data policies in proteomics are starting to revolutionise the field
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…
Temperature-controlled packaging
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.
