Special Issues-10-09-2020

Special Issues

Reshaping The Landscape

October 09, 2020

From the Editor

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An introduction from guest editors, Koen Sandra and Davy Guillarme, on this special supple-ment from LCGC Europe focusing on recent developments in biopharmaceutical analysis.

Exploring Capillary Electrophoresis–Mass Spectrometry for the In-Depth Intact Native Analysis of Cysteine-Conjugated Antibody-Drug Conjugates

October 09, 2020

Features

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This article explores the potential of microchip capillary electrophoresis–mass spectrometry (CE–MS) for the characterization of intact biopharmaceuticals, and how this technique can effectively be employed to monitor essential quality attributes of interest.

In Search of The Needle in The Mariana Trench: Host Cell Proteins and the Problem of Dynamic Range

October 09, 2020

Features

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This article explores the analytical challenges associated with HCP monitoring and reviews recent advances in HCP characterization, with special emphasis on high performance liquid chromatography mass spectrometry (HPLC–MS)-based methods and HCP enrichment techniques.

Analytical Separation Methods for Therapeutic Oligonucleotides

October 09, 2020

Features

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The diverse nature of oligonucleotide therapeutics leads to the requirement for multiple separation methods to characterize quality attributes. Highly chemically-modified to improve efficacy and resilience to nucleases, they are challenging to analyse using a single method. This article discusses multiple chromatographic separation methods, and the benefits of mass spectrometry (MS).

Physicochemical Methods for Vectors and Ancillary Materials in Cellular and Gene Therapies

October 09, 2020

Features

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Cellular and gene therapies (CGTs) have contributed significantly to the improvement of clinical outcomes for patients in the recent years. This paper discusses a range of physicochemical methods that play an important role in the difficult characterization of viral vectors, to meet the unique needs of CGT manufacturing process development, process and product characterization, and the quality control testing of these materials.

Rapid Adeno-Associated Virus Genome Integrity Analysis by Capillary Gel Electrophoresis

October 09, 2020

Features

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In this paper, two adeno-associated virus (AAV) genome integrity analysis workflows are introduced; a standard sample preparation protocol and an accelerated procedure, both utilizing capillary gel electrophoresis with laser induced fluorescent detection (CGE–LIF) to analyze the released nucleic acids.