in t ro du C t io n Since the early introduction of biologic based therapeutics, the presence of protein aggregates can compromise safety and efficacy.1 Given these factors, protein aggregates are typically monitored throughout the production of a biotherapeutic. While a variety of analytical techniques have been used to analyze soluble aggregates, the dominant technique continues to be size-ex...

In recent years, the use and number of biotherapeutics has increased significantly. For these largely protein-based therapies, the quantitation of aggregates is of particular concern given their potential effect on efficacy and immunogenicity. This need has renewed interest in size-exclusion chromatography (SEC). In the following review we will outline the history and background of SEC for the ...

Protein aggregation, where molecules assemble into dimers, trimers, tetramers, or larger multimers, is a common occurrence that can have devastating consequences. Biotherapeutic proteins, such as monoclonal antibodies, can give rise to severe immunological events as a result of aggregation. Therefore, quantitation and monitoring using size exclusion chromatography (SEC) are paramount during man...

This article reports a MEMS (Micro-ElectroMechanical-Systems)-based column separator designed for potential integration with portable medical point-of-care testing (POCT) devices. The MEMS column uses size exclusion chromatography (SEC) to pre-separate raw samples by size, and is made of polydimethylsiloxane (PDMS) fabricated on a glass slide. The MEMS SEC column separates 300 ng/mL of beta-hum...

Investigating translationally active mRNA involves isolating and sequencing RNA directly associated with the ribosome. Traditionally, isolating these complexes involved sucrose gradient ultracentrifugation, which is tedious and technically difficult. ARTseqTM (active RNA translation) Ribosome Profiling Kits provide an alternative method for obtaining ribosome-protected RNA fragments using size-...

Therapeutic monoclonal antibodies (mAbs) represent a milestone in pharmacological development. Their superiority is based on the combination of high specificity, low toxicity, and long half-life that characterizes biologics. If biologics have Achilles' heel, it is their potential immunogenicity. To better understand the impact of the size of immune complexes of mAbs on anti-drug antibody (ADA) ...

This paper deals with the use of tetrabutylammonium fluoride/dimethylsulfoxide (TBAF/DMSO) to characterize the molar mass distribution of non-derivatized cellulosic samples by size exclusion chromatography (SEC). Different cellulose samples with various average degree of polymerization (DP) were first solubilized in this solvent system, with increasing TBAF rates, and then analyzed by SEC coupl...