Simple Plex for Bioprocess Development

Automation for Process-Related Impurity Testing

To meet increasing demands and safety standards, fast and reproducible detection of host cell proteins (HCPs) is essential during the manufacturing process of a biotherapeutic. Automated Simple Plex™ assays on Ella™ are the combination of sample throughput and hands-off workflow needed to increase your process development bandwidth.

• Ella reduces the manual operation of an immunoassay by 80%, to simply diluting samples and adding them to a cartridge
• With a run time of just 75 minutes, Ella allows your process development to iterate faster
• Simple Plex assays provide sub-picogram level detection, giving you superior assay sensitivity at each stage of the purification process

The reduction in manual steps enables a high level of reproducibility and data quality – all with a method that's fast and easy to transfer! Moreover, Simple Plex assays have broad detection coverage to the most relevant HCPs and automatically obtain triplicate results for every sample.

Partners in Process Development

To bring you the best quality immunoassays, we've partnered with the industry leader in bioprocess impurity testing, Cygnus Technologies.

Cygnus Technologies provides the highest level of validation and characterization of the antibodies that go into their assays, ensuring that HCP coverage is complete and reproducible. Learn more about Cygnus’ orthogonal characterization, in accordance with standard FDA and ICH guidelines.

How Does the Simple Plex CHO HCP 3G-1 Assay Compare with the Cygnus CHO HCP ELISA?

Take your CHO HCP measurements to the next level with Ella. In this application note, we demonstrate assay comparability between the Simple Plex CHO HCP 3G-1 assay and the Cygnus 3G ELISA (F550-1) to show that you get the same high-quality data you would expect from the Cygnus ELISA but with an automated, streamlined workflow. Now you can get the best of both worlds by running the Cygnus CHO HCP 3G immunoassay on Ella.

Linear correlation of the 3G-1 Simple Plex and plate ELISA assays

GlaxoSmithKline Uses Ella to Establish Walk-Away Method for CHO HCP Impurity Analysis

Biopharmaceutical analytical scientists at GSK use Ella to accurately quantitate HCP concentrations throughout process development. Read this Biotechniques publication to learn how Ella is allowing their scientists to quickly report CHO HCP trends and speed up process-related decision making and batch release of drug product.