Serum and Plasma Assays
To predict the in vivo properties of a new biological entity (NEB) as precise as possible, it is inevitable to evaluate its stability and biological activity in a simulated natural environment.
At Biofidus AG we have access to fresh human whole blood, plasma and serum for performing bioactivity and stability assays. We offer a detailed characterization of degradation and efficacy profiles for your active pharmaceutical ingredient (API). Our experts in this field will guide you through the variety of available assay types and help you find the optimal analytical setup for your project.
In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods tailored to your API, its individual formulation matrix and your distinct analytical question.
Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert.
Our capabilities
- Stability and bioactivity assessment in human whole blood, plasma and serum
- Analysis of degradation profiles and adverse side products
- Tailored assays in accordance with ICH guidelines
- Sourcing of reference products (Originators)
- Method qualification according to ICH guidelines
Standalone and integral bioanalytical services
Tell us about your project
We‘ll advice you to define your assay needs
Technologies used
- LC-ESI-MS
- LC-ESI-TOF
- RP-UV
- Size exclusion chromatography (SEC)
- ELISA
- Cell-based assays
For all inquiries related to our serum or plasma assay portfolio reach out directly to our expert PD Dr. Johannes Greiner.
