Cygnus Technologies

Articles by Cygnus Technologies

Host cell protein (HCP) analytics have evolved dramatically over the past 25 years from early “black box” approaches with only semiquantitative outputs to advanced mass spectrometry (MS) methods capable of identifying every HCP in a drug substance. Although HCP ELISAs remain semiquantitative, they are no longer opaque. This paper demonstrates how leveraging advanced technologies ensures that both generic and process-specific ELISAs are fit for purpose and support data-driven risk assessments for product safety. It also highlights case studies on HCP antibody coverage analysis using 2D-PAGE and MS-based approaches, along with new data from the Cygnus CHO Lipase Assay using stable isotope–labeled peptides and PRM-MS absolute quantification.

Predicting Viral Clearance: DOE, HTS, and AAV Case Studies Using a Non-Infectious MVM Surrogate in Downstream Development

Non-infectious mock virus particles that mimic the physicochemical properties of live infectious viruses can be used as spiking agents during viral clearance testing. Review results from several studies using an economical spiking surrogate—a non-infectious minute virus of mice-mock virus particle (MVM-MVP)—to demonstrate viral clearance in industrial processes. Tuesday, Oct 6, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST On demand available after final airing until Oct. 6, 2021.