January 15th 2024
A review of advances in mRNA analysis using LC and LC–MS.
December 12th 2023
Scientists from Fudan University in Shanghai, China created a system for reducing retention-time variations in metabolomic analysis using ultrahigh-performance liquid-chromatography coupled with mass spectrometry (UPLC-MS).
December 1st 2023
An introduction from our guest editors.
Innovative native separation strategies coupled with native mass spectrometry techniques to characterize biopharmaceuticals close to their natural state
The authors discuss key findings from recent biosimilarity assessments they conducted on biosimilars of granulocyte-colony-stimulating factor (G-CSF),
insulin glargine, rituximab, and trastuzumab.
Capillary Electrophoresis–Mass Spectrometry for the Analysis of Biopharmaceuticals
An overview of the important and versatile role that capillary electrophoresis coupled to mass spectrometry plays n biopharmaceutical analysis.
CE–MS using noncovalent coated capillaries provides advantages for purity and stability analysis of biopharmaceuticals.
Analytical Tools for Enabling Process Analytical Technology (PAT) Applications in Biotechnology
For PAT, you need to choose the right analytical methods. Here's how.
Current Applications of UHPLC in Biotechnology Part II: Proteins and Glycans
A discussion of how UHPLC is used to conduct intact protein–antibody analysis and glycoprofiling to characterize biopharmaceutical drugs
Current Applications of UHPLC in Biotechnology Today, Part I (Peptide Mapping and Amino Acid Analysis)
A description of the use of UHPLC in the biopharmaceutical industry to characterize drug substances through peptide mapping and amino acid analysis
Glycoproteins and Biotechnology — Recombinant Biopharmaceutical Products: Identification, Characterization, and Chemical Equivalency?
Glycoproteins appear to have become the most common biopharmaceutical product today, and they also seem to be increasing in popularity and importance with time.
Popular Cell Expression Systems in the Biotechnology Industry
The authors describe the most common cell-based protein expression systems and purification strategies used in the biotechnology industry.
Analytical Tools for Characterization of Biotechnology Products and Processes
In the first installment of LCGC's newest column, the authors address the topic of analytical biotechnology.
Analytical Method Validation for Biotechnology Proteins, Peptides, and Antibodies
The authors explore how true (complete) method validation of biopharmaceuticals must be forthcoming.
Impurity Determinations for Biotechnology-Derived Biopharmaceuticals and Related Products
This installment of "Validation Viewpoint" column addresses, in the hopes of clarifying what the biopharmaceutical industry is required to do today to identify and quantify impurities in their biotech, proteinaceous products.
Targeted Quantitative Protein Analysis in Human Serum Using High-Resolution Multiple Selected Reaction Monitoring Assays
A common endpoint for a biomarker discovery experiment is a list of putative marker proteins. The next step is then to perform targeted quantitative measurements of these proteins in an expanded patient population to assess their validity as markers. Analytical accuracy and precision are required for unambiguous quantitative analysis of targeted proteins from very complex mixtures. Wide dynamic range and high sensitivity are critical for detecting low-abundance proteins. Such an assay also is appropriate for "targeted discovery" experiments, where the goal is to quantitate a large number (up to hundreds) of known proteins in a complex sample.
Validation in Biotechnology and Well-Characterized Biopharmaceutical Products
This article describes the current situation in FDA-regulated areas, as well as characterization of these products. Finally,the author discusses the various stages of early- and late-phase product developments.
Separation Technology in Drug Discovery
In this first installment of this new column, editor Tim Wehr explores the evolution of drug discovery and the analytical challenges that lie ahead.
2 Commerce Drive Cranbury, NJ 08512