The Sievers Eclipse* Bacterial Endotoxins Testing (BET) Platform empowers users to be conscious of today’s needs to protect valuable natural resources while still complying with the strict analytical and regulatory requirements drug and device manufacturers must meet.
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Issue 3 2020
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The promise of virally vectored DNA and mRNA vaccines is tremendous in terms of vaccine safety and speed of response to new pathogens. This article explores why these approaches have attracted attention in light of the COVID-19 pandemic and why they are highly appropriate for rapid vaccine development and deployment.
Five patent issues that European biosimilar developers should consider before entering the US market
As patents on originator biologic medicines begin to expire, there are growing opportunities for biosimilars to enter the market at lower prices. Joshua Whitehill, Natasha Daughtrey and Grace Truong discuss key aspects of US patent law that European developers should consider before entering the American market.
In an industry faced with numerous regulatory hurdles, the end-user experience can often be neglected. Nikki Withers spoke to two packaging design experts who discuss their approach to pharmaceutical packaging and why they always have the end user at the forefront of their minds.
The circuit of life: saving on manufacturing, waste and delivery-related supply chain inefficiencies
Many pharmaceutical companies have complicated supply chains that are inefficient and ill-equipped to deal with current demands. This article explores how digitalising the healthcare supply chain can address the pharmaceutical sector's increasing financial-, capacity- and waste-related strains associated with our ageing population and the soaring costs of new treatments.
How implantable systems and microparticle depot injections are meeting the needs of long-acting drug delivery
Implantable systems and microparticle depots are used in many areas of drug delivery to release medicines at a controlled rate within the body. The use of these long-acting dosage forms eliminates the need for frequent administrations via traditional routes of administration, which ensures patient compliance and results in improved outcomes.…
Repurposing existing drugs can be attractive as the process is often less risky, more cost effective and can be undertaken in less time. This article discusses the logic behind drug repurposing and the approaches that are currently being explored.
For over 30 years, pharmaceutical and medical device product release has relied solely on endotoxin assays using Limulus Amebocyte Lysate (LAL). This article addresses the potential risks associated with relying on a single raw material in a fragile supply chain and explores alternative testing options.
Since making its debut in the pharmaceutical setting, the range of applications for which Raman microscopy imaging has been used continues to grow. Here, Harald Fischer, Damon Strom, Miriam Boehmler, Eleni Kallis and Thomas Dieing demonstrate the versatility of confocal Raman imaging by exploring a variety of real-world applications.
As companies race to develop a COVID-19 vaccine, various discussions about patents and ownerships of the vaccine have occurred, especially in light of funding from various governments. This article explores the patent and regulation issues, with a focus on patent extensions and suspensions for global good.
The impact of rapid microbiological methods (RMM) on the scientific community has been widespread and profound. Lucpah Nekati explains how their numerous benefits enable deeper understanding, faster and more easily.
COVID-19 has severely disrupted the lives of many people around the world. In this article, corporate partner Theo Godfrey and competition partner Russell Hoare from the life sciences team at law firm CMS Cameron McKenna Nabarro Olswang LLP consider some issues related to COVID-19 that have impacted life sciences merger…
Adherence to medicines – ie, maintaining consistency and complying with correct dosage – is vital for treatment success, yet patient non-adherence remains a global concern, risking a multitude of consequences for both the patients and healthcare systems. Dave Elder explores the issue of medicine adherence and expounds on current efforts…
High data quality and integrity is critical to ensure successful manufacturing of a drug. This whitepaper discusses how utilisation of software systems such as SampleManager LIMS enables and promotes compliance with regulations for the manufacturing of a drug.
Application note: Pharmaceutical analysis using UV-Vis: compliance with USP Chapter <857> and European pharmacopoeia (Ph. Eur. Chapter 2.2.25)
USP general chapter and Ph. Eur. chapter 2.2.25 guide instrument operational qualification protocols for UV-Vis spectroscopy. This technical note demonstrates how to ensure qualification of the Cary 3500 as per global pharmacopoeias' requirements.