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A recent study has introduced comprehensive quality control procedures for large-scale plasma proteomics analyses. The research provides valuable insights into optimizing performance, enhancing reproducibility, and ensuring quantitative accuracy in proteomics investigations.

New Procedures Enhance Quality Control for Large-Scale Plasma Proteomics Analyses

 is Group Technical Director of Crawford Scientific Group and CHROMacademy. His background is in pharmaceutical R&D and polymer chemistry, but he has spent the past 20 years in training and consulting, working with Crawford Scientific Group clients to ensure they attain the very best analytical science possible. He has trained and consulted with thousands of analytical chemists globally and is passionate about professional development in separation science, developing CHROMacademy as a means to provide high-quality online education to analytical chemists. His current research interests include HPLC column selectivity codification, advanced automated sample preparation, and LC–MS and GC–MS for materials characterization, especially in the field of extractables and leachables analysis.

Manufacturing capillary gas chromatography (GC) columns is a very complex procedure, with many production factors to consider. In this LCGC Blog, Tony Taylor lists some of the vital components of the GC column-making process.

Capillary GC Column Manufacture – A Troubleshooting Insight

Waters Corporation has purchased Wyatt Technology, expanding both parties' reach in biopharmaceutical development and creating better healthcare technology for all.

Waters Corporation Purchases Wyatt Technology in Billion-Dollar Deal

 is a Full Professor and Shimadzu Distinguished Professor of Analytical Chemistry in the Department of Chemistry & Biochemistry at The University of Texas (UT) at Arlington. He joined the faculty at UT Arlington in 2005 after completing a Ph.D. in Chemistry at Virginia Tech under the direction of Prof. Harold M. McNair and a post-doctoral fellowship at the University of Vienna under Prof. Wolfgang Lindner. Research in the Schug group spans fundamental and applied areas of separation science and mass spectrometry. Schug was named the LCGC Emerging Leader in Chromatography in 2009, and most recently has been named the 2012 American Chemical Society Division of Analytical Chemistry Young Investigator in Separation Science awardee.

If your decision making relies on analytical chemistry, then you want to be confident that the measurements are an accurate representation of the matrix that is being analyzed, and that they are of “publication” quality. But how can you know for sure if the analytical laboratory that you’ve selected is producing reliable data? 

The LCGC Blog: Laboratory Accreditation is Not a Cloak of Infallibility 

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

Qualification and calibration of high performance liquid chromatography (HPLC) chromatographs is a regulatory requirement, but how proscriptive should guidance be?

It’s Qualification, But Not  As We Know It?

Everyone who is reading this column is interested in chromatography, and I want to shine a light on the industrial side of the application space. 

The LCGC Blog: Controlling Retention Time Drift in Industrial Chromatography

As a result of the pharmaceutical cGMP for the 21st century and quality by design (QbD) initiatives championed by regulators, the biopharmaceutical industry has been looking for ways to introduce more automated and higher information content analyses into manufacturing, late-development, and quality control (QC). Mass spectrometry (MS-) based attribute monitoring assays have been proposed as key tools to provide the sensitivity, throughput, selectivity, and flexibility required for monitoring critical product and process attributes for biopharmaceutical production and release. Two analytical workflows, subunit multi-attribute monitoring (MAM) and peptide MAM, have emerged to dominate this discussion, and this article is intended to reflect on the active debates over the needs, challenges, and practical limitations for adopting MS-based attribute monitoring for late-development and QC.

Mass Spectrometry in Late Development and QC: Practical Considerations for Multi-Attribute Monitoring and Beyond

Quantitative determination of the counterions associated with pharmaceutical salts is a mandatory requirement for quality control. While ion chromatography (IC) is the standard technique in most laboratories, capable of delivering excellent sensitivity, specificity and flexibility, there are other simpler and quicker analytical methodologies that may should be considered for this quality control application.

Quality Control Methodologies for Pharmaceutical Counterions

This fourth and last instalment in the “Separation Science in Drug Development” series provides an overview of modern practices of quality control in small-molecule drug development, including activities such as setting specifications, method validation and transfer, release and stability testing, and authoring chemistry, manufacturing, and controls (CMC) sections of regulatory filings.

Separation Science in Drug Development, Part 4: Quality Control

Mass spectrometry (MS) is emerging as a critical tool in biopharmaceutical late stage development, manufacturing, and quality control (QC) environments. The rapid growth of biologics in development, the increasing demand for more robust analytical technologies to directly monitor the critical quality attributes (CQAs) of these new drugs, and longer term industry initiatives aimed at improving quality and productivity, such as quality by design (QbD) regulatory submissions and continuous manufacturing, are all fueling a greater need for mass monitoring with MS.

Quality Control/Quality Assurance (QA/QC) | Topics