단백질 특성분석
신약 개발의 각 단계에서 수행되는 단백질 특성분석 결과는 신약 승인자료의 제출, 그리고 시장출시의 승인과 직접적인 연관이 있습니다.
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.
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.
