Ensure Successful Approval of Biologics With a Complete Product Characterization Solution
Successful approval of biologics depends on robust product characterization — an analytical data package that defines the characteristics and structure of the biotherapeutic and proves the safety, efficacy, purity, quality, and strength. This in-depth analysis is not only required for compliance with FDA and EMA/MHRA guidelines, the information gathered also informs critical decisions as the product moves through each phase of the pipeline, from candidate selection to transferring processes to commercial-scale manufacturing.
Sartorius helps manufacturers advance drug candidates from early-stage development to commercialization by offering a complete biologic characterization solution. This solution consists of purpose-built instrumentation platforms and pre-validated off-the-shelf assays, as well as custom assays to meet the characterization challenges of increasingly complex biological therapeutics. That, combined with access to industry experts, saves valuable time and resources, leading to a robust data package that will guide success in every phase.
Accelerate your development timeline by skipping time-consuming assay development in favor of Sartorius’ validated analytical and safety assays to characterize your product.
Our ready-to-use, pre-qualified assays have been extensively tested with a range of molecules. More complex assays can be customized to meet your needs
A dedicated client manager serves as a single point of contact. This individual develops a depth knowledge of your work and is positioned to provide concrete, individualized support.
In addition, you have access to Sartorius’ extended team of experts — technical and regulatory teams available to discuss any challenge you might encounter related to your product characterization work
Manufacturers can rely on the quality of Sartorius’ validated equipment and systems. During the development of early phase assays, Sartorius keeps an eye on future validation needs to ensure the transfer of assays to a regulated facility is fast and efficient. Sartorius’ facilities are fully cGMP compliant and have excellent audit track records with the FDA and EMA/MHRA