Analytical methods development
All-in-one analytical service platform including batch release, stability study and product characterization
Highly experienced in release and stability studies, including physicochemical, bioactivity, biosafety and characterization related testing as well as specification setting, for both clinical and commercial products, which can meet China, Europe, and the US filing requirements.
Standardized sample management workflow, including sample storage, sampling plan, as well as sample and data tracking with electronic management systems.
Comprehensive product characterization capabilities, including structure, function, heterogeneity, and impurity analysis for various biologics modalities (e.g., mono- and multi-specific antibodies, fusion proteins, ADCs).
Quality by design (QbD) guided product critical quality attribute (CQA) assessment, extensive experiences in analytical method development, validation, transfer, and life-cycle management.
Highly experienced in comparability study for both clinical and post-approval process changes, as well as similarity study for biosimilar development.
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All-in-one analytical service platform including batch release, stability study and product characterization
Highly experienced in release and stability studies, including physicochemical, bioactivity, biosafety and characterization related testing as well as specification setting, for both clinical and commercial products, which can meet China, Europe, and the US filing requirements.
Standardized sample management workflow, including sample storage, sampling plan, as well as sample and data tracking with electronic management systems.
Comprehensive product characterization capabilities, including structure, function, heterogeneity, and impurity analysis for various biologics modalities (e.g., mono- and multi-specific antibodies, fusion proteins, ADCs).
Quality by design (QbD) guided product critical quality attribute (CQA) assessment, extensive experiences in analytical method development, validation, transfer, and life-cycle management.
Highly experienced in comparability study for both clinical and post-approval process changes, as well as similarity study for biosimilar development.
High throughput and automated analytical instrumentation
Cutting-edge analytical instrumentation platform that can provide routine as well as enhanced characterization services, including primary structure, higher-order structure, purity and impurities, charge heterogeneity based on IEX and FFE separations, glycosylation heterogeneity, potency and biosafety, and pharmacopeia testing.
Fully automated and high throughput sample preparation platform (Tecan) and testing equipment (LabChip) helps reduce the sample analysis cycle significantly.
