Serum & Plasma Assays
Serum and plasma assays – what is special about them?
To predict the in vivo behaviour of a new biological entity (NBE) as accurately as possible, it is essential to evaluate its stability and biological activity in a matrix that closely mimics the human body. Assays performed in human serum, plasma or whole blood provide a more realistic view of degradation, binding, interference and functional activity than buffer-only systems and are increasingly important for biologics, biosimilars and advanced therapies.
At Biofidus, we have access to fresh human whole blood, plasma and serum to perform bioactivity and stability assays under physiologically relevant conditions. We offer detailed characterization of degradation and efficacy profiles for your active pharmaceutical ingredient (API), helping you understand how your molecule behaves in complex biological matrices. Our experts guide you through the variety of available assay formats and work with you to define the optimal analytical setup for your development stage and regulatory needs.
In accordance with your needs, we adapt and, where required, qualify (according to ICH guidelines) our platform methods, tailoring them to your API, its individual formulation matrix and your specific analytical questions – from early in vitro screening to late-stage CMC and comparability.
Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert
