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Analytical techniques

 

Solid-state NMR spectroscopy: predicting stability in lyophilised biological products

2 November 2018 | By , ,

The emergence of biological drugs has led to an increase in lyophilised drug products in the market. Lyophilisation is a technique used to stabilise parenteral formulations in a solid form with the goal of producing chemically and physically stable, homogeneous, and high-quality lyo-products.

LC-MS based multi-attribute method for characterisation and QC testing of protein therapeutics

2 November 2018 | By

For several decades mass spectrometry (MS) has been used in the characterisation of protein pharmaceuticals.1-3 However, its use in the laboratory for quality control (QC) product release testing has been quite limited for a number of reasons, for example: instrument complexity and software are not readily amenable to validation, extensive…