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As part of EPR’s Women in Pharma series, Dr Jane Osbourn, Vice President of Research & Development, MedImmune, talks to Science Editor Dr Zara Kassam about the importance of breaking through self-imposed barriers…
Crystallisation is a common step in the synthesis of organic compounds used to isolate and purify the desired product. As the importance of crystallisation has increased and chemists improve the processes involved, process analytical technology (PAT) tools can be used to design, analyse, and control them. This article considers the…
In this issue Dave Elder discusses issues around the manufacture of film coatings and Adeyinka Aina and colleagues consider the potential medicinal uses and efficacy of the flavonoids epigallocatechin and epicatechin, which can be extracted from the Spondias mombin plant.
Glucosamine is sold as a food supplement worldwide, but its production is poorly regulated. A direct and reliable method for the quality control of glucosamine in commercial products is of great importance. This article describes a simple, fast and validated ultra-performance liquid chromatography-quadrupole time of flight (UPLC-QToF) for the determination…
The European Pharmacopoeia chapter on methods for microbiological quality control was recently revised to include a number of significant changes. In this In-Depth Focus Michael Miller provides the first part of this two-part review and Kevin Williams discusses a paradigm change in biologics microbiological contaminant control.
In the field of bioanalysis, the use of sample preparation is fundamental to ensuring that data is robust. This article looks at some of the various forms of sample preparation that are commonly used for the pre-treatment of biological fluids and considers the advantages and disadvantages of each approach.
Welcome to European Pharmaceutical Review’s Guide to Outsourcing, the fourth in our series of ‘Guide to…’ supplements. In this edition, five leading companies that provide outsourcing services explain how their portfolio meets current industry needs.
Contaminant detection methods derived from the innate, proinflammatory responses of rabbits and Limulus blood have been used to determine the existence of microbial artefacts in small-molecule drugs (SMDs) and large-volume parenterals (LVPs) for decades...
In this issue: Sample preparation - is it possible to have too much? Developing successful over-the-counter syrup packaging for the highly regulated EU market. In-line process PAT in continous wet granulation, and much more...
As part of EPR’s Women in Pharma series, Lori Reilly, Executive Vice President, Policy, Research & Membership, talks to Science Editor Dr Zara Kassam about the importance of having strong female mentors...
Traceability and serialisation have been the talk of the industry for many years, with regulatory bodies worldwide starting to introduce legislation that will help to eradicate counterfeit medicines from the supply chain.
As part of EPR's Women in Pharma series, Petra Wicklandt, Senior Vice President, Head of Global Chemical and Pharmaceutical Development, Merck, talks to Science Editor Dr Zara Kassam about facing challenges in the pharmaceutical industry and turning them into solutions...
Dante J Marciani, President and CSO of Qantu Therapeutics, reviews the current evidence and controversy in the hunt for a vaccine against Alzheimer's disease and considers the future.
European Pharmacopoeia Chapter 5.1.6, Alternative Methods for Control of Microbiological Quality, was recently revised and published in Ph. Eur. Supplement 9.2. The new chapter comprises a number of significant changes from the original version published in 2006. Prior revisions to a similar chapter and technical report from the USP and…
The quality attributes of manufactured pharmaceutical products include the physical, chemical, and microbiological characteristics of the raw materials, excipients and active pharmaceutical ingredient (API), as well as the final drug product (see Table 1). Absence of microbiological contamination is considered a critical quality attribute due to its potential to dramatically…
