[HTML][HTML] Chromatographic strategies for the analytical characterization of adeno-associated virus vector-based gene therapy products

S Fekete, MK Aebischer, M Imiołek, T Graf… - TrAC Trends in …, 2023 - Elsevier
In recent years, the biopharmaceutical industry's interest in gene therapy modalities has
increased dramatically. To warrant their quality during manufacturing and …

Critical challenges and advances in recombinant adeno‐associated virus (rAAV) biomanufacturing

Q Fu, A Polanco, YS Lee, S Yoon - Biotechnology and …, 2023 - Wiley Online Library
Gene therapy is a promising therapeutic approach for genetic and acquired diseases
nowadays. Among DNA delivery vectors, recombinant adeno‐associated virus (rAAV) is one …

Stimulus-responsive assembly of nonviral nucleocapsids

M Hori, A Steinauer, S Tetter, J Hälg, EM Manz… - Nature …, 2024 - nature.com
Controlled assembly of a protein shell around a viral genome is a key step in the life cycle of
many viruses. Here we report a strategy for regulating the co-assembly of nonviral proteins …

N-glycomic profiling of capsid proteins from Adeno-Associated Virus serotypes

Y Xie, M Butler - Glycobiology, 2024 - academic.oup.com
Adeno-associated virus (AAV) vector has become the leading platform for gene delivery.
Each serotype exhibits a different tissue tropism, immunogenicity, and in vivo transduction …

Advances in analytical technologies for emerging drug modalities and their separation challenges in LC-MS systems

M Malarvanan, V Ravichandiran, D Paul - Journal of Chromatography A, 2024 - Elsevier
The last few years have seen a rise in the identification and development of bio-therapeutics
through the use of cutting-edge delivery methods or bio-formulations, which has created bio …

A Novel and Simplified Anion Exchange Flow‐Through Polishing Approach for the Separation of Full From Empty Adeno‐Associated Virus Capsids

F Meierrieks, A Weltken, K Pflanz, A Pickl… - Biotechnology …, 2024 - Wiley Online Library
Adeno‐associated viruses (AAV) are widely used viral vectors for in vivo gene therapy. The
purification of AAV, particularly the separation of genome‐containing from empty AAV …

[HTML][HTML] A Novel Method for Separating Full and Empty Adeno-Associated Viral Capsids Using Ultrafiltration

D Sarmah, SM Husson - Membranes, 2024 - mdpi.com
Adeno-associated viral vectors (AAVs) are the predominant viral vectors used for gene
therapy applications. A significant challenge in obtaining effective doses is removing non …

Mass spectrometry friendly pH-gradient anion exchange chromatography for the separation of full and empty adeno-associated virus (AAV) capsids

F Guapo, F Füssl, L Strasser, J Bones - Analytical Methods, 2023 - pubs.rsc.org
The proportion of full and empty capsids represents a critical quality attribute of adeno-
associated virus (AAV)-based therapeutics. In this study, pH-gradient anion exchange …

An improved high-resolution method for quantitative separation of empty and filled AAV8 capsids by strong anion exchange HPLC

S Schrecke, K McManus, C Moshfegh… - … in Bioengineering and …, 2024 - frontiersin.org
Cell and gene therapy (CGT) is a field of therapeutic medicine that aims to treat, prevent,
and cure diseases using engineered cells (stem cells, immune cells, and differentiated adult …

Membrane chromatography for AAV full capsid enrichment: Process development to scale up

JH Hernandez, K Boenning, A Kavara… - … of Chromatography B, 2024 - Elsevier
The recent FDA approval of several adeno-associated virus (AAV)-based gene therapies is
driving demand for AAV production. One of the biggest AAV manufacturing challenges is …