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Simple Plex™ Assays for Bioprocess Testing
First, see how Simple Plex assays on the EllaTM platform can be used in the process impurity testing workflow. Next, meet Ella and request pricing. Finally, choose the Simple Plex Assay that best meets your needs.
Table of Contents
Ella Automates 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 less than 90 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 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.
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 |
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.
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.
Simple Plex Protein A Assay
The Simple Plex Protein A assay on Ella offers researchers an automated solution that minimizes user variability and ensures consistent and reliable results for your bioprocess workflow.
- Wide dynamic range reduces sample dilutions while maintaining sensitivity
- Quick results with data in less than 90 minutes
- Less hands on time with built-in standard curves
- Easier sample prep with simplified pretreatment
- Simplified workflow, just load your samples and walk away
Simple Plex Applications
COVID-19 Research
COVID-19 Research
Quantify cytokine and pro-inflammatory responses to SARS-CoV-2 infection in 90 minutes using an automated, multianalyte format.
Inflammation Research
Inflammation Research
Simple Plex assays enable rapid and reproducible quantification of inflammatory responses such as cytokine release syndrome and sepsis.
Cancer Biomarker Research
Cancer Biomarker Research
Simple Plex assays for cancer research have the sensitivity to profile low abundance cancer biomarkers.
Neuroscience Research
Neuroscience Research
Measure key neuroscience biomarkers such as neurofilament light (NF-L) and neurofilament heavy (NF-H) in CSF, plasma, and serum.
Cell Therapy Research and Development
Cell Therapy Research and Development
The Simple Plex HEK 293 HCP 3G assay on the Ella platform offers broad detection coverage of this host cell protein (HCP).
Bioprocess Testing
Bioprocess Testing
Iterate your workflow faster with Simple Plex CHO HCP 3G-1 assays for process-related impurity testing.
Preclinical Research
Preclinical Research
With a four-log range of detection, Simple Plex assays have the sensitivity to pick up even very low picogram-per-milliliter levels of endogenous mouse or rat analytes.
Viral Titer Assays
Viral Titer Assays
Get highly reproducible adeno-associated virus and lentivirus titer data with no manual steps in just 90 minutes.
Simple Plex Cartridge Denominations
| 16x1 | 32x1 | 16x2 | 16x3 | 16x4 | 32x2 | 72x1 | 72x2 | 32x3 | 32x4 | 32x5 | 32x6 | 32x7 | 32x8 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Samples | 16 | 32 | 16 | 16 | 16 | 32 | 72 | 72 | 32 | 32 | 32 | 32 | 32 | 32 |
| Plex | 1 | 1 | 2 | 3 | 4 | 2 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
| Replicates | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 2 | 3 | 3 | 2 | 2 | 2 | 2 |
| Reportable Results | 16 | 32 | 32 | 48 | 64 | 64 | 72 | 144 | 96 | 128 | 160 | 192 | 224 | 256 |
