Stephan Koza | Authors

Articles

Waters - Size-Exclusion Chromatography for the Impurity Analysis of Adeno-Associated Virus Serotypes

Monitoring the size heterogeneity of AAV-based gene therapy therapeutics is potentially important to ensure consistent product quality and efficacy. We demonstrate that the levels of both high-molecular weight (HMW) and low-molecular weight (LMW) impurities in AAV capsid preparations can be separated on a Waters 450 Å Protein BEH SEC column for a series of AAV serotypes.

Waters - An Anion-Exchange Chromatography Method for Monitoring Empty Capsid Content in Adeno-Associated Virus Serotype AAV8

The single-stranded DNA (ssDNA) content of AAV capsids in AAV-based gene therapy preparations impacts the efficacy of this treatment modality. We demonstrate that AAV8 capsids without and with full length ssDNA can be separated and their relative abundances determined on a Waters Protein-Pak Hi Res Q strong anion-exchange column.

Size-Exclusion Ultra Performance Liquid Chromatography Analysis of Insulin

Insulin was the first recombinant pharmaceutical produced. Currently, one of the critical quality control attributes of therapeutic insulin in the US and European Pharmacopoeia (USP and EP) monograph is the level of covalent high molecular weight (HMW) insulin as determined by HPLC size-exclusion chromatography.