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Characterisation and quality control of proteinbased biotherapeutics has historically been a lengthy and challenging process due to their complexity and inherent heterogeneity.
This article highlights the 10 most popular news stories published by European Pharmaceutical Review in 2019.
Raman microscopy is well suited to pharmaceutical studies, including the analysis of drug delivery systems and their performance.
Sustainable reagents based on recombinant horseshoe crab Factor C (rFC) provides advances in endotoxin testing.
Over the last decade, Transmission Raman spectroscopy (TRS) has been increasingly implemented in pharmaceutical laboratories as a highspeed, accurate, quantitative analysis solution.
This in-depth focus includes features that examine how microbiologists can advance their methods of study, discuss the regulatory guidelines regarding genotoxic impurities and explore Raman spectroscopy as a non-invasive analysis technique.
Included in this in-depth focus are features on recombinant albumin as a versatile stabiliser and how nanobots will evolve as an effective drug delivery technique.
Within this in-depth focus are articles exploring the potential of gene therapies and manufacturing viral vectors as well as a discussion on recent M&As within the biopharmaceutical industry.
In this in-depth focus are articles on the latest innovations in pharmaceutical packaging design and how to comply with the new EU Medical Device Regulations (MDR) for product labelling.
For companies in highly regulated industries, compliance is second only to survival as a business. Yet why do so many companies struggle with compliance? Dr Rebecca Godfrey explores this issue and provides practical steps that companies can take to ensure best practice.
ICH M9 biopharmaceutics classification system-based biowaivers1 is currently at step 2b and feedback from interested parties is being evaluated.2 This guideline should reach the implementation stage (step 4) during 2020. However, industry still has concerns relating to several key areas of the guidance. Here, Dave Elder summarises these ICH M9…
The current regulatory system for medical devices in the UK, as an EU member state, is complex enough without the uncertainties surrounding Brexit. In this article, legal advisor Paul Ranson reviews the current and forthcoming regimes and how Brexit may impact manufacturers and regulators working in this space.
In this issue are articles that explore the impact of M&As within the life science industry, discuss the security trends for medicinal packaging and investigate genotoxic impurities within pharmaceutical products. Also included are features on nanobot drug delivery systems and Raman as an effective analytical approach.
Dr Mohamedali discusses Canada's stance on medical cannabis and breaks down some misconceptions surrounding cannabinoids, as well as exploring the future for the pharmaceutical ingredient.
Cannabinoids are of growing interest in the pharmaceutical industry. Mark Tucker explains how this class of compounds is viewed across the world and why regulations surrounding them hinder their progress, yet remain necessary.
