To analyse biosimilars you will have data from many workflows and many different vendor instruments, Byosphere can help you with how to get the most out of your data with the least challenges – it is vendor neutral, maintains data integrity, offers a complete suite of analytical workflows, being an enterprise system helps breaking down silos across your organization and with innovative advanced tools like Dashboards powered by Deep Query you can get insights rapidly on across studies and projects.
With the inexorable push towards large molecules, biosimilar companies are faced with fresh challenges to demonstrate the veracity and accuracy of their biotherapeutic characterization workflows.
Seamlessly move between non-GxP and GxP to satisfy regulatory requirements with Byosphere®. With industry accepted scientific gold standard workflows, regardless of the mass spec platform scientists can create workflows that allow comparisons with speed and with confidence
Shortly after the approval of US Biosimilar legislation in 2012, regulatory agencies made the point that the analytical burden was a much higher proportion compared to the innovator molecule. Therefore, it is important that the analytical data from tools like LC-MS are processed efficiently and reliably, under GxP conditions.