Byosphere for Biosimilars

Maximize the potential of your biosimilar analysis with Byosphere. The Byosphere cloud platform effortlessly integrates data from diverse workflows and vendor instruments, ensuring data integrity and facilitating seamless collaboration across your organization.

Byosphere's comprehensive suite of analytical workflows, coupled with innovative tools like Dashboards powered by Deep Query, empowers you to gain rapid insights and accelerate your research and development initiatives.

The biosimilar industry faces increasing pressure to demonstrate the accuracy and reliability of biotherapeutic characterization workflows. Byosphere empowers seamless transitions between non-GxP and GxP environments, ensuring compliance with regulatory requirements.

With industry-standard scientific workflows and support for diverse mass spectrometry platforms, scientists can confidently compare biosimilars with speed and accuracy. Given the heightened analytical burden for biosimilars, efficient and reliable processing of LC-MS data under GxP conditions is crucial.

Complete analytical characterization is essential to support biosimilarity and involves a comprehensive assessment of various parameters, including glycosylation profile, PTMs, disulfide mapping, charge variant analysis, and higher-order structure analysis.

Byosphere provides a comprehensive suite of analytical tools with predefined data processing workflows to efficiently address these characterization needs. Efficient visualization capabilities enable seamless comparison of critical quality attributes (CQAs) between innovator and biosimilar products.

Disulfide bonds are crucial for the stability and function of antibody therapeutics. Disulfide mapping is a vital CQA workflow that requires accurate and efficient analysis. Byosphere's automated tools rapidly characterize disulfide bonds, identifying shuffling and quantifying disulfide pairs, trisulfides, and free cysteines.

The platform's automated labeling and in-depth data review facilitate detailed comparisons of expected and shuffled disulfide bonds. Additionally, Byosphere generates shareable reports that are consistent across different MS platforms and labs.