To reach the market, biosimilars must follow a strict regulatory pathway and meet stringent requirements set by different regulatory agencies across the globe, which gives rise to a unique set of challenges.
Scientists at biotherapeutic companies can choose to address these challenges through in-house efforts, or partner with other organizations offering specialized services and products in this area, such as Labcorp and Svar Life Science.
We offer bioanalytical services for biosimilar development to help overcome several of the common challenges, such as bioanalytical program design, analyzing the clinical significance of identified differences, and obtaining critical reagents.
We can also help put processes in place for PK and immunogenicity biosimilar assay design, validation aspects, along with biosimilar bioanalytical development and sample analysis. > Learn more
The iLite® cell-based reporter-gene assays are MOA-reflective and biologically relevant assays that offer a fast and convenient way to accurately measure and quantify drug activity and immunogenicity.
As an added benefit, the cells are provided assay-ready for a quicker workflow and contain a second normalization reporter-gene for added convenience. > Learn more