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The third instalment in this series provides an overview of modern practices of separation science in small-molecule drug development. It highlights approaches in high performance liquid chromatography (HPLC) method development and physical or chemical characterization to support process chemistry and formulation development, and for assessment or control of clinical trial materials. The roles of separation scientists in analytical development and salient chromatographic methodology trends are also discussed.

LGC Standards has been awarded a Responsible Sourcing status by Sedex for its Standards division in Germany. A non-profit membership organization, Sedex is dedicated to improving responsible and ethical business practices in global supply chains.

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Researchers from the USA have developed a simple and derivatization-free gas chromatography (GC) method for the quantitative analysis of oleic acid and related fatty acids.

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Researchers from Universidade Federal de Minas Gerais, Brazil, have used multiple analytical techniques including IEC and ATR‑FTIR spectroscopy to investigate bovine meat adulteration.

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Monoclonal antibody (mAb) treatment is among the most effective method of diagnosis and treatment of a broad range of diseases, including autoimmune disorders, cardiovascular diseases, infectious diseases, cancer, and inflammation. There is an extensive development pipeline for protein and mAb therapeutics, emphasizing the need for innovative and efficient analytical tools that result in faster analysis times. This article explores the use of supermacroporous particles for the analysis of mAbs.

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To mark the Chromatographic Society’s 60th birthday, The Column interviewed the current President of The Chromatographic Society, Dr. Paul Ferguson, and Associate Principal Scientist for Separation Science at AstraZeneca, Macclesfield, UK, on the past, present, and future of the Chromatographic Society - and separation science.

The increased use of electronic data and computerized systems has introduced new challenges to maintaining data integrity. With regulated companies under increased scrutiny by regulatory authorities, companies need to ensure they have a thorough understanding of their regulated systems and how to assess them for gaps. Waters will provide insight on the current focus for data integrity with specific examples of how to monitor Waters Empower data. We will also provide additional tools and services that can help prepare for internal and external audits.