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Nuclear magnetic resonance (NMR) spectroscopy is a technique that most have heard of but many avoid, especially when dealing with larger biological macromolecules. Why? The common wisdom is that NMR can be complicated, expensive and involves quantum physics and complex equations. In the fast-paced industrial biopharmaceutical environment there may be…
A survey by the Internal Investigations Forum has highlighted vast differences in the quantity and quality of complaint reports globally and that companies need to nurture trust to improve internal relations. Here, Gary Giampetruzzi, Thomas Hauser and Jenny Pu provide an analysis of the results, including where there are areas…
Over the past decade, the pharmaceutical industry has witnessed rapid growth in outsourcing services, driven by various factors including the growth of small molecules, increasing API complexities and the need to optimise costs. Here, Peter DeYoung shares his thoughts on the key trends he expects to see in the contract…
Analogous to nuclear magnetic resonance spectroscopy, EPR measures electron spins, rather than those of atomic nuclei. Its investigative power has always offered unique insight, but it seems that only now is the technique coming into its own.
The ever-increasing demand for cannabis-based products requires US state regulators to set guidelines that ensure products are safe for human use. However, as medicinal cannabis moves forward at a rapidly increasing pace, regulations are falling behind. Here, Robert Thomas discusses the many inconsistencies across US states for monitoring levels of…
There are currently major seismic shifts happening in the pharmaceutical sector that are disrupting the status quo. Some of the most notable changes are the rise in biosimilars, the downward pressure on pricing, increased global spending and advances in technology, all of which are impacting the logistics sector and affecting…
Enhancing the production of pharmaceutical tablets is extremely important in modern manufacturing processes and companies will go to great lengths to ensure production runs efficiently in order to stay competitive. As time and capital implications become drivers within the production of solid dosage forms, investigation into improving production methods is…
Glidants and lubricants are important additives in the production of solid dosage formulations. This article compares the results of various methods to characterise the flowability of blends, demonstrating the importance of considering the impacts that glidants may have, not only on the flowability of blends, but the physical attributes of…
Polyelectrolyte multilayers (PEMs) are promising drug carriers with potential applications in the delivery of poorly soluble drugs. In this article, Sumayah Abdul-Jabbar and Paul Royall discuss the approaches for PEM construction and drug release and detail several applications of multilayered particles in therapeutics.
Extractables and Leachables Safety Information Exchange (ELSIE) has been the most influential industry group in developing guidelines for extractables and leachables. In the wake of the ICH convening a new group to develop a concept paper and business plan on their Q3E Impurity Guideline, Dave Elder discusses the strides that…
The recombinant Factor C (rFC) assay has been developed to help alleviate the pressures of a growing demand for the Limulus amoebocyte lysate (LAL) assay. Here, Sven Deutschmann and Johannes Reich discuss the advantages of rFC and its recent recognition by the European Pharmacopoeia as an alternative endotoxin test.
Any envisioning of ‘the future’ of testing contains elements extrapolated from the past.
In this guide to Analytical Testing, SUEZ explains how to maximise efficiency without compromising on quality.
Dr Finn Bauer discusses how Merck KGaA and its SAFC® portfolio brand is addressing drug formulator challenges.
In the light of recent media coverage about product recalls – particularly resulting from the detection and presence of NDMA – this article outlines ways to avoid the wide-ranging negative impacts on patients, pharmacies, manufacturers, pharmaceutical companies and health authorities and offers ways to mitigate the risk of future recalls.
