Successful IND Submission and Market Authorization Rely on Robust Protein Characterization for Every Stage of Development
Biologics manufacturers must have an in-depth understanding of their therapeutic protein in terms of structure, physicochemical properties, and biological activity. With an increasing number of complex therapeutics based on multiple mechanisms of action, the identification and characterization of proteins have become equally complex. Identifying and linking the attributes of a protein to clinical performance are required through development, but those essential characterization activities also serve as the basis for program acceleration, reducing risk of delays down the line.
Sartorius’ protein characterization services are scaled to each phase of drug development. These services include development, qualification and validation of product characterization assays, such as cell-based potency assays, binding assays and physicochemical tests. Our panel of assays have been pre-qualified with commercial monoclonal antibodies and can shorten analytical development timelines.
The range of analytical testing services Sartorius offers is backed by a team of scientists with years of technical and regulatory experience.
Protein Characterization Services
Proven Experience and a Comprehensive View
Since 2007, our experienced team has established a range of platform methodologies available for quick development of critical bioassays. During clinical phases, a qualified potency bioassay is generally required for lot release, while at commercial phase, this assay must be fully validated. Leveraging a functional bioassay alongside structural and physicochemical analyses at early phases of development allows developers to make key decisions early on, minimizing delays in costly clinical phases.
Because characterization runs concurrently throughout clinical and commercial phases, it’s possible to inform decisions on pool and clone level, analyze critical quality attributes and get a head start on complex bioassay development needs. Plus, our protein characterization forms an integral part of our platform of services for protein-based therapeutics. This includes cell line development featuring the high-performing Cellca cell line and optimized media, as well as fully compliant cell banking and cell bank characterization services to ensure a seamless progression from DNA to MCB.