Cygnus Technologies

Webinar Date/Time: Thu, May 21, 2026 11:00 AM EDT

This eBook explores the growing analytical challenges of managing host cell protein (HCP) impurities in biopharmaceutical manufacturing, with particular focus on complex biologics such as gene therapies and CHO-derived products. It examines the evolution of HCP analytics from early ELISA and Western blot methods to advanced orthogonal approaches combining Antibody Affinity Extraction (AAE™) with mass spectrometry, which enable more precise identification, coverage analysis, and absolute quantification of high-risk HCPs. A featured study demonstrates the utility of a parallel reaction monitoring (PRM) assay using stable isotope-labeled peptides to quantify six CHO HCP lipases at sub-ppm detection levels.

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.

Webinar Date/Time: Thu, May 16, 2024 11:00 AM EDT

Non-infectious mock virus particles that mimic the physicochemical properties of live infectious viruses can be used as spiking agents during viral clearance testing.

Webinar Date/Time: Tue, May 16, 2023 11:00 AM EDT

Tuesday, October 11, 2022 at 11 AM EDT Learn about best practices in Host Cell Protein (HCP) assay development and qualification. Improve your understanding of the advanced orthogonal methods used to fully characterize HCPs in your process

The Avitide AVIPure® – AAV9 Residual Ligand Assay kits are intended for quantifying the AVIPure® – AAV9 Ligand.

Bridging Anti-CHO HCP Antibodies from Two 3rd Generation Cygnus CHO HCP ELISA Kits by AAE-MS

Bridging Anti-CHO HCP Antibodies from Two 3rd Generation Cygnus CHO HCP ELISA Kits by AAE-MS

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.