Elucidation of Structure
With the current breadth of modalities used to express biopharmaceutical products, advances in antibody molecular engineering, contemporary biotechnological or biological products are inherently complex.
A core tenet of the CMC filing is the 3.2.S.3 characterization section, “Elucidation of Structure and Other Characteristics”. This section requires the in-depth characterization of a biotechnological or biological product. Your partnership with FUJIFILM Diosynth Biotechnologies provides access to leading-edge, innovative technologies to characterize your product.
The characterization module requires defining the:
- Physicochemical composition, physical properties, and primary structure of the desired product
- Pattern of heterogeneity of the desired product and demonstrate consistency with that of the lots used in preclinical and clinical studies
- Post-translationally modified forms (e.g., glycoforms, glycation, clipping, amino acid misincorporation)
- Biological activity, potency, and functional properties
- Higher-order structure, which may include secondary and tertiary structure, protein aggregation, and oligomerization
Our Characterization Technologies
Our comprehensive characterization technologies include:
- Mass spectrometry methods for primary structure, post-translational modifications, sequence variant analysis, structural characterization by Native MS and ion-mobility MS
- Biochemistry methods for physicochemical composition and product-related substances
- Cell-based assays, binding potency and functional properties
- Multiple orthogonal techniques to evaluate secondary, tertiary and quaternary structure
- Methods to characterize subvisible and submicron particles
- Hyphenated UPLC, CE and icIEF-MS methods for product-related species isolation and structural confirmation
- Host Cell Protein (HCPs) identification and quantitation, screening problematic HCPs and clearance studies
- LC/MS, CAD or ELSD based methods for process impurity characterization
No single analytical method can appropriately characterize the complexity and personality of these products. We will apply our collective experience with 1000+ biologics to guide you in selecting the appropriate characterization package based on the biopharmaceutical product modality and the appropriate regulatory filing (e.g. IND/IMPD to begin first-in-human clinical trials through BLA/MAA commercial applications).
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Discuss Your Project
Contact us to learn more about our elucidation of structure services.
