GYROS KITS

Gyrolab kits: Bioprocess Kit convenience. Gyros quality.

Easy-to-use kits require fewer manual steps, reducing hands-on time and risk for error.

Gyrolab™ CHO-HCP Kit 1

Gyrolab CHO-HCP kit 1 is designed to measure Chinese Hamster Ovary (CHO) Host Cell Proteins (HCP) impurities with performance that addresses many of the limitations of ELISA. The kit, which covers a broad spectrum of HCPs, broadens the analytical range from typically two orders of magnitude to four, simplifying spike recovery and dilution linearity experiments.

Easy to use kit

• Optimized kit ensures assay robustness, convenience and rapid results
• No need for assay development

Broad dynamic range

• Measurement range over 4 logs
• Minimizes dilutions and repeats

Automation and efficient analysis

• Reduces hands-on time and risk for errors
• Reproducible high quality data
• 96 data points in 75 min

Assay principle

The Gyrolab CHO-HCP sandwich assay is run on Gyrolab Bioaffy 1000HC CD, which is optimized for HCP analysis. The biotinylated anti-HCP antibody, which is captured on streptavidin-coated beads in the affinity column, binds to a broad spectrum of CHO-HCPs. Bound HCP is then detected using a fluorescently labeled anti-HCP antibody. The Gyrolab instrument transfers reagents and samples to the CD and then records the laser-induced fluorescence from each column. Samples are quantitated using a standard curve.

Typical assay data

• Dynamic range compared to ELISA
• Accuracy, intra-assay precision and inter-assay precision
• Dilutional linearity
• Spike recovery

Gyrolab CHO-HCP Kits 2 -5 

Developing immunoassays to monitor HCP impurities faces many challenges. Typically, hundreds of different HCPs are produced during cell culture. HCP impurities may vary in abundance, physicochemical and immunogenic properties, and contribute differently to the overall response of the assay. A single, generic assay for HCP cannot cover the diversity of HCP mixtures from different bioprocesses. Therefore, reliance on one kit risks missing HCPs that could lead to adverse effects.

Gyros has therefore developed a panel of Gyrolab CHO-HCP kits to complement Gyrolab CHO-HCP Kit 1 and increase the possibility of finding a kit that best matches your bioprocess.

Gyrolab CHO-HCP Kits 2–5 provide diversity through being generated in both goat and rabbit using slightly different antigens. They have been optimized for the Gyrolab platforms to provide consistent and sensitive assay performance without the need for assay development. The analytical performance of Gyrolab CHO-HCP Kits 2 -5 is similar to Gyrolab CHO-HCP Kit 1.

Assay Performance

• Gyrolab CHO-Kit 2-5 Assay characteristics
• Dose response curves for all five Gyrolab CHO-HCP kits

Gyrolab CHO-HCP Scouting Kit

To simplify the selection of the optimal generic kit, the Gyrolab CHO-HCP Scouting Kit bundles Gyrolab CHO-HCP Kit 1–5 and includes guidelines on which experiments should be performed and how to evaluate and determine which kit works best for a specific process.

• Evaluation of CHO-HCP content in a bioprocess sample using 
  Gyrolab CHO HCP Kits 1 -5 

Gyrolab™ Protein A Kit

Gyrolab Protein A Kits are designed to detect MabSelect SuRe™ ligands and native protein A residuals in samples, such as antibody preparations after Protein A purification processes. In Gyros’ automated method, samples are acidified in Gyrolab Mixing CD 96 to dissociate protein A-IgG complexes. The amount of Protein A is then determined by a sandwich immunoassay.

• Gyrolab Protein A Kits for quantification of GE Healthcare’s MabSelect SuRe™ ligand and native protein A
• Automates acid dissociation
• Delivers precise, accurate data in the presence of high IgG concentrations
• Provides results for 96 data points in 2 hours

Standard assay protocol:

1. Dilute samples to appropriate IgG concentration
2. Dilute standards in series to set up seven points of diluted standard between 0.03 ng/ml and 120 ng/ml
3. Transfer the ready-made capture and detection reagents to the microtiter plate according to the Gyrolab Control Loading List
4. Prepare a microtiter plate with standards, capture and detection antibodies, acid dissociation buffers and wash buffers
5. Load samples, reagents and Gyrolab Mixing CD 96 in a Gyrolab instrument
6. Results available within 2 hours

Typical assay data

• Reproducibility — Protein A
• Reproducibility — MabSelect SuRe
• Intra and Inter Precision for Native Protein A and MabSelect SuRe
• Recovery

Gyrolab huIgG Kits 

Gyros has developed two kits to rapidly determine human intact IgG titers over broad concentration ranges;

• Gyrolab huIgG Kit– High Titer for µg – mg concentrations
• Gyrolab huIgG Kit – Low Titer for ng – µg concentrations

The kits are composed of ready-to-use reagents and are compatible with two Bioaffy CDs that differ in sample volume. The dynamic range of each assay, typically 3-4 logs, depends on the CD used – Bioaffy 1000 HC for low titers and Bioaffy 20 HC for high titers. Gyrolab systems completely automate the analytical process and generate 96 or 112 data-points in approximately one hour. The kits are designed to quantify human IgG1, IgG2 and IgG4 in cell cultures.

• Standard curves from Gyrolab huIgG Kits
• Gyrolab huIgG Kit description
• Results from Gyrolab huIgG Kit correlate well with those determined with ELISA