Marc Baiget Francesch explains how commensal bacteria can be opportunistic pathogens and why treating them as merely a light threat to cleanrooms can bring disastrous consequences.
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How modern chromatography data systems are improving regulatory compliance in pharmaceutical manufacturing
Delivering confident QA and QC in pharmaceutical manufacturing is of critical importance. This article discusses how the latest chromatography data systems are ensuring compliance with modern regulatory requirements.
Native liquid chromatography coupled to mass spectrometric analysis for the assessment of higher order structures of proteins
The accurate measurement of the molecular mass of proteins is an essential component of protein characterisation. In this article, Ioannis Papayannopoulos discusses the applications of native protein chromatography coupled to mass spectrometry to enable the characterisation of tertiary structures and non-covalent interactions.
This issue focuses on the regulatory challenges associated with increased ventilator demand during COVID-19, as well as articles investigating the use of LC-MS for protein characterisation, improving efficiency with continuous processing and the risks posed by cleanroom contaminants. Other features discuss the continual evolution of solid dosage forms and the…
Over the last few years, biologics have continued to make up an increasing proportion of biopharmaceutical sales and pipeline candidates. Cory E Muraco and Wayne Way discuss current trends in biologics analysis.