Product Characterization Services
Ensure successful approval of biologics with comprehensive protein characterization and biosafety testing services
Successful approval of biologics depends on robust product characterization — an analytical data package that defines biotherapeutic structure and key attributes and demonstrates safety, efficacy, purity, quality, and strength. This analysis is essential for FDA and EMA | MHRA compliance and guides decisions from candidate selection through commercial-scale manufacturing.
Sartorius supports manufacturers from early development to commercialization with a complete biologic characterization solution, including purpose-built instruments, pre-validated assays, and custom methods for complex biologics across a range of modalities. Combined with access to industry experts, this approach saves time and resources while delivering the data package needed for success at every phase.
Accelerate your development timeline with validated analytical and safety assays from Sartorius, reducing the need for time-consuming assay development.
Our ready-to-use, pre-qualified assays have been extensively tested with a range of molecules. More complex methods can be customized to meet your needs
A dedicated client manager serves as a single point of contact. This manager develops an in-depth knowledge of your work and is positioned to provide concrete, individualized support.
In addition, you have access to the extended Sartorius team of experts, including technical and regulatory teams available to discuss challenges related to your product characterization work.
Manufacturers can rely on the quality of our validated equipment and systems. To support fast, efficient assay transfer to a regulated facility, Sartorius considers future validation needs during early-phase assay development. Sartorius facilities are fully cGMP-compliant and have excellent audit track records with the FDA and EMA | MHRA.
