The new services, called NBE Product Characterization, will be offered by Sartorius Stedim BioOutsource, a contract testing organization based in Glasgow, UK, and Cambridge, MA, US.
“For common phys-chem and mAb functional methods, we can now deliver a much quicker route to NBE characterization, in particular potency and binding assay development by working with our technology platforms,” a company representative told us.
Sartorius Stedim BioOutsource provides a range of testing for innovator molecules available either as off-the-shelf assays or custom assay development, according to the company. These fully-customizable tests include cell-based potency assays, bioassays and binding assays, as well as physicochemical and structural analyses.
The spokesperson said the demand for new biological medicines is driven mainly by the increase in demand for better treatments for chronic conditions and cancer therapy. “As the market for biologics continues to grow, new potential drugs enter the development pipeline and require extensive characterization to support their journey from pre-clinical research through to regulatory submission,” they added.
As part of a biologics regulatory submission at the investigational new drug (IND) and biologics license application (BLA) phase, the spokesperson noted that product characterization is essential, as it provides the required evidence to demonstrate proper identification, quality, purity, and strength of the investigational drug.