Impurity analysis| Gyros Protein Technologies immunoassays

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Impurity analysis for biopharmaceutical quality and safety

Impurity analysis is a critical component of biopharmaceutical development and manufacturing. During the production of biologics, various process- and product-related impurities can arise, including host cell proteins, residual reagents, aggregates, and other contaminants. These impurities must be carefully monitored and controlled to ensure product quality, safety, and regulatory compliance.

Our impurity analysis solutions support the detection and characterization of impurities throughout development—from early process optimization to late-stage manufacturing and quality control. By combining sensitive immunoassays with automated workflows, we help biopharmaceutical developers generate reliable impurity data that supports both development decisions and regulatory submissions.

Precision and reproducibility with Gyrolab automated immunoassay platform

Accurate impurity detection requires assays that deliver consistent and reproducible performance across many samples and runs. Using the Gyrolab automated immunoassay platform, we provide high-precision impurity analysis with minimal variability.

The Gyrolab system’s microfluidic disc technology allows precise control of assay conditions and reagent handling. Nanoliter-scale reactions ensure efficient use of samples and reagents while maintaining high analytical sensitivity. This automated approach reduces variability associated with manual assays and ensures consistent impurity quantification across studies.

These capabilities make the platform well-suited for both development studies and regulated analytical environments.

Reduced manual handling and increased data integrity

Manual immunoassay workflows can introduce variability and increase the risk of inconsistencies between runs or operators. The Gyrolab platform addresses these challenges by automating critical assay steps such as reagent addition, incubation, and washing.

Automation provides several key benefits for impurity analysis:

Reduced operator-dependent variability
Improved reproducibility across runs and laboratories
Consistent assay performance for regulated testing environments

By minimizing manual intervention and standardizing assay execution, the platform helps ensure robust, traceable, and high-integrity data, supporting reliable impurity monitoring throughout the product lifecycle.

Time to results

Results in just over an hour, compared to several hours or overnight with ELISA.

Hands-on time

Automated processing reduces manual pipetting and intervention.

Dynamic range

Fewer dilutions are needed to bring samples into range.

Matrix tolerance

The flow-through format reduces background in complex matrices such as serum.

Sample volume

Nanoliter-scale assays require significantly smaller sample volumes than plate-based methods.

Throughput and runs required

Higher pass rates and faster runtimes reduce repeat burden keeping your project timelines on track.

One primary goal during HCP assay development is a broad dynamic range to avoid repeat analysis and additional sample dilutions. A broad dynamic range is especially important for bioprocess HCP analysis, since the concentration range of HCP impurities in process samples may vary greatly. Gyrolab assays and kits offer broad analytical ranges, reducing the number of dilutions required to hit the analytical range, thereby reducing the need for repeat runs. CHO HCP 3G Solution for Gyrolab^® consists of the CHO HCP 3G Assay Reagent Set for Gyrolab

from Cygnus Technologies and the Gyrolab Bioaffy ™ 1000 HC Assay Toolbox. The reagent set is derived from the same antibodies and antigen used in the Cygnus 3rd Generation CHO HCP ELISA kit, Cat# F550-1.Link Consumables and accessories

In situations where assays with process-specific reagents are required, Gyrolab Bioaffy™ 1000 HC Assay Toolbox and Gyrolab Bioaffy™ 4000 HC Assay Toolbox provide the flexibility and automation needed to deliver rapid results.

Explore the CHO HCP 3G Solution for Gyrolab