This issue includes an investigation into the potential for continuous production lines in biopharma, information on new guidance released by China on their regulatory processes and an assessment of the FMD to improve the drug supply chain. Also within the issue are articles on nanomedicine development, monoclonal antibodies and pharmaceutical…
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In this issue we explore reasons behind critical key drug shortages in the EU, whether viability methods effectively detect all viable organisms and how companies can future-proof their digital technologies ahead of Brexit. Also included are articles on higher order protein structure, FMD compliance and Raman spectroscopy.
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…
In this issue we look at the challenges of shipping temperature-controlled products, the potential use of blockchain for pharma, and using MALDI-TOF for identification of peptides in suspected illegal medicinal products. The edition also includes articles on aseptic containment, legal advice on licensing negotiations and an In-Depth Focus article from…
In this issue: Navigating roadblocks to clinical success: decision-making from molecule to clinic, Raman spectroscopy for the qualitative analysis of falsified and substandard medicines, and an overview of risk assessments for elemental impurities: implementation of ICH Q3D guidelines.
In this issue: LC-MS multi-attribute methods for the characterising and QC testing therapeutics, integrating data from Quality Control and Production to enable fast and informed decisions, and Solid-state NMR spectroscopy: using freeze drying to predict the stability of biological products.
In this issue: DNA microarray for detecting, identifying and determining antimicrobial-resistant bacteria; the advantages of single-use technology and a framework for an implementation strategy; risk management when designing chemical safety assessments for pharmaceutical packaging systems.