Assessment of the Degradation Pattern and Extent of PEG Interferon α-2b Using a Stability-Indicating SE-HPLC Assay

Assessment of the Effects of Glycosylation on the Pattern and Kinetics of Degradation of Lenograstim in Comparison to Filgrastim Using a Stability-Indicating Orthogonal Testing Protocol

“…It is also crucial for the development and validation of stability-indicating analysis protocols [14,15]. Such protocols are employed also during drug development stages to provide evidence of how the quality of a drug substance or drug product changes over time in response to a variety of environmental factors [15,16].…”

“…Stability studies and profiling of product and process-related impurities are required by local regulatory authorities and should be monitored not only during production and batch release but also in postmarketing surveillance studies [11,14,15,23].…”

Immunoaffinity extraction using conformation-dependent antibodies coupled to SE-HPLC for the development of stability and potency-indicating assay for quadrivalent human papillomavirus vaccine

“…Reliable analytical tools are crucial for economical process development, production and batch release of biopharmaceuticals [28][29][30]. In the case of the quadrivalent HPV vaccine a robust, precise and high throughput quantitation of the VLPs using HPLC was a challenging task since the four types of VLPs had almost identical physicochemical properties.…”