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.

bioprocess development reactor

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.

Cygnus Technologies logo

The Simple Plex CHO HCP 3G-1 Assay

The Simple Plex CHO HCP 3G-1 assay (SPCKB-OT-003714) on Ella and Runner software are GMP-compliant and ready for establishment in GMP labs. The assay is based on the same antibodies currently used in the Cygnus CHO HCP ELISA Kit, 3G (F550-1), which utilizes antibodies that have been evaluated for reactivity to more than 1,000 individual HCPs present in CHO strains by state-of-the-art Antibody Affinity Extraction™ and mass spectrometry methods. The Simple Plex CHO HCP 3G-1 Assay is available for purchase directly from Cygnus Technologies.

Simple Plex CHO HCP 3G-1 Assay Specs
LLOQ 0.26 ng/mL
ULOQ 400 ng/mL

Download Spec Sheet

Ella Cygnus CHO HCP plate

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.

 

Simple Plex HCP Assay versus Cygnus HCP ELISA

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.

Discount Pricing on Ella for Biopharma Customers

Accelerate your biotherapeutic development with these exciting instrument bundles. For a limited time, receive 50% off Ella when you purchase a Maruice or MFI system.

Ella is your fully automated CHO HCP immunoassay solution. Purchase 10 Cygnus CHO 3G-1 Simple Plex 72x1 cartridges, and we’ll credit the cost towards an Ella system.

 

             

Talk to one of our Specialists about Bio-Techne’s full portfolio of bioprocess solutions for your lab today.

Simple Plex Applications

COVID-19

COVID-19 Research Multiplex Assays

Inflammation

Inflammation Research Assays

Cancer

Cancer Research Multiplex Assays

Neuroscience

Neuroscience Research Multiplex Assays

 

Cell Therapy

Cell Therapy Research Multiplex Assays

Bioprocess Dev.

Bioprocess Development Multiplex Assays

Preclinical Res.

Simple Plex for Preclinical Research
 
Other Simple Plex Products

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  16x1 32x1 16x2 16x3 16x4 32x2 72x1 32x3 32x4 32x5 32x6 32x7 32x8
Samples 16 32 16 16 16 32 72 32 32 32 32 32 32
Plex 1 1 2 3 4 2 1 3 4 5 6 7 8
Replicates 3 3 3 3 3 3 3 3 3 2 2 2 2
Reportable Results 16 32 32 48 64 64 72 96 128 160 192 224 256

Single Plex

Single Plex cartridge

Multianalyte

Multianalyte cartridge

Multiplex

Multiplex cartridge

Customizable

Customizable cartridge

Stocked

Stocked cartridges